ALCON
Carrie Corbett

Carrie was instrumental in setting Alcon up for success when they divested from Novartis in 2019. She undertook a companywide implementation program to replace all legacy systems concurrently with Veeva Vault Clinical Suite, Vault Quality Suite, Vault RIM Suite, and Vault PromoMats. Her leadership and desire for innovation enabled Alcon to complete this ambitious task ahead of schedule. Carrie’s can-do attitude and collaborative team-oriented approach were critical in achieving program excellence.

BECKTON DICKINSON
Montoya Love

Montoya led the implementation and rollout of Vault PromoMats to drive global, harmonized ways of working at Becton Dickinson (BD). During the implementation, BD also acquired two large companies and Montoya managed their integration into the business. Montoya’s positivity and energy, combined with deep product knowledge, has been inspirational to her team members. She was critical in holding many moving parts together to successfully complete the global rollout.

ILLUMINA
Matthew Purner

Matt spearheaded the implementation of Vault CDMS, Vault CTMS, Vault eTMF, and Vault MedComms during a pivotal time as Illumina transitioned from a laboratory to a diagnostics business. He recognized the need to move away from legacy systems and adopt modern technology solutions. As business lead, Matt’s inspiring vision kept everyone on track to meet an aggressive timeline. His infectious enthusiasm inspired the Illumina team to work together to establish a strong technology foundation for future growth.

PENUMBRA
David Templeton

David led Penumbra’s journey to achieve a single clinical view of data and operations. He managed the implementation of the Vault Clinical Suite to achieve this, replacing disconnected systems. His relentless focus on the end goal and articulation of his vision ensured teams were clear about their part in the program. David set a high standard and held himself and others accountable. This commitment to quality resulted in full visibility across clinical data and operations.

The post Celebrate the Leaders Advancing the Medical Device and Diagnostics Industry first appeared on Veeva.

Although we missed connecting in person, we were pleased to welcome more than 500 people to the regulatory track of the 2020 Veeva R&D and Quality Summit Online. Over the course of two days, Summit attendees participated in small group discussions, watched live demos, and joined sessions led by 12 different Veeva Vault RIM customers.

The Regulatory track kicked off with a fireside chat featuring two heads of global regulatory operations. Dominique Lagrave of Amgen and Gina Schmidt of Sanofi—both Veeva Hero award winners—provided practical advice for organizations undertaking a regulatory business transformation.

Lagrave described Amgen’s four-year, multi-phase journey to bring together regulatory data and documents in a single source of truth. Their Vault RIM solution now supports nearly 10,000 users with streamlined, end-to-end regulatory processes for submission planning through archiving. Lagrave called change management one of the project’s biggest challenges and encouraged attendees to engage the business early to ease the transition to new ways of working.

Schmidt shared Sanofi’s experience replacing 50-plus legacy systems with a global Vault RIM solution for all products, markets, and functional areas. She said a key objective of the transformation is to enable more data-driven decision making throughout the company. In a later session, Marianne Smith, Joe McLaughlin, and Donna Wolfington echoed that sentiment when they shared Sanofi’s strategies for driving a cultural shift that makes improving data quality everyone’s responsibility.

The regulatory track’s second fireside chat focused on the benefits of taking an agile approach to RIM implementation and business transformation. Veeva welcomed back Dr. Stephen Cook, regulatory processes and systems business lead at GSK, who credited an accelerated RIM rollout to agile system delivery. He also explained how an agile mindset helped his team realize opportunities for Vault RIM to transform the daily work of colleagues in clinical, non-clinical, CMC, and manufacturing.

Regina Freunscht, head of global regulatory operations at Merck KGaA, Darmstadt, Germany, said agile working methodologies reduced the time and resources required for their global Vault RIM implementation. Freunscht also stressed the value of agile thinking and processes in today’s rapidly changing regulatory environment. Merck KGaA’s transformation is ongoing, and teams continue to “create their own future.”

In addition to a full slate of customer-led sessions, Summit attendees also heard from Veeva’s product management experts in two roadmap sessions. Kate Wilber and Kelly Finlan-Dansbury explained how Vault Registrations is evolving to support new IDMP regulations. Later that day, Uri Reich, Cindy Ling, Rich Merrick, and Rolando Sa shared enhancements for Vault Submissions, Vault Submissions Publishing, and Vault Submissions Archive including a key initiative around Active Dossier.

To view these and other Summit sessions on demand through November 13, please register here.

The post Top Pharma Companies Discuss Regulatory Transformation at Veeva R&D and Quality Summit first appeared on Veeva.

As pharmaceutical companies produce higher volumes of digital content to meet ever-growing demand, we need to stay focused on complying with regulatory requirements. Just last year, the Office of Prescription and Drug Promotion issued numerous warning letters with regard to claims, and because of this, the agency has now increased its focus on false or misleading claims.

This doesn’t mean that anyone is intentionally doing anything wrong. But it does prompt us to take a closer look at how we currently manage our claims and to work towards having the best, most effective claims review process possible.

Several considerations make this critical. The first is the significant time and expense required for an agency to reference a piece of content. This is especially true if you’ve just hired a new agency – they need to get up to speed on learning your library, your claims, and the content they’ll be working with. Bad or faulty referencing can increase the number of review cycles, which in turn leads to reviewer fatigue. A good way to prevent this is to incorporate a medical pre-review, to ensure that the medical material is fully vetted before other committee members start their review.

A second obstacle to effective claims management is high personnel turnover at agencies, which means that who you previously trained may not be the same person handling your work. It’s therefore critical to establish well-documented training for your claims management process. Claims are not easy. Input from highly skilled subject matter experts is essential: regulatory professionals, legal counsel, and medical information advisors. We rely on these well-trained experts to keep up with industry trends, assist with business strategy, provide direction, mitigate risk, and interpret medical data and regulatory requirements.

During the approval process for a claim or reference, subject matter experts should review marketing content to determine if it’s appropriate for a specific audience, such as HCPs or consumers. Your medical expert should always have the final word in ensuring that references are credible and medically accurate.

Another aspect of the claims process involves what I call my “cousins,” by which I mean the people or places I look to for guidance. I trust several organizations as authorities on referencing citations for websites, reprints, and other kinds of literature: the Modern Language Association, the American Psychological Association, and the American Medical Association. Every company I’ve worked for relies on at least one of these bodies for formatting their references. Once you’ve chosen and set up your format structure, it becomes easy to search and locate references in your library.

Claims Management Goals

Claims come from a variety of sources: for example, a label update, a new campaign tactic, or a recent publication that aligns with how your product is being used. As you develop a piece of content, you’ll want to highlight the list of supporting references. When new information arises, your first priority should be ascertaining whether you have approval to include it in your materials.

It’s important to identify the individuals within company leadership who need to sign off on new claims and references. Performing this evaluation upfront will eliminate confusion for the team during the materials review process, enabling you to focus on your desired claim and its supporting evidence. It also helps foster a well-organized reference library that sets the standard for all stakeholders. In addition, it can serve as the basis for establishing an anchor naming convention that will be helpful to others later on.

The most critical goal is gaining leadership agreement and sign-off. Once you have both, you can begin tracking your information. Bring together your list of claims, audience information, and supporting evidence to create a reference usage report that documents the citations in your materials.

This usage report will be helpful when transitioning to Veeva’s new claims management feature, Vault PromoMats Auto Claims Linking.

Automating and optimizing the claims management process with Vault Auto Claims Linking will help you gain the following:

• Less reliance on paper and spreadsheets
• A standardized workflow that helps save time
• A seamless process for providing claims information
• An established program for onboarding new personnel

Vault Auto Claims Linking has improved claims creation and management across all points of the process: agencies can more easily find and link claims, MLR teams can review and approve claims quicker, and marketing organizations can create content faster.

If you’re interested in learning more about Vault Auto Claims Linking, check out this video on Automating Claims Management.

The post Journey to Claims Management first appeared on Veeva.

Life sciences companies – both small and large – shared the benefits of their quality transformation initiatives at the 2020 NA R&D and Quality Summit. They drove greater operational agility, seamless information exchange across functions, and improved partner collaboration.

Bristol-Myers Squibb: Harmonizing quality across GxPs to achieve operational excellence
In the quality track keynote, BMS shared how they integrated, streamlined, and simplified quality systems and processes across GxP domains. The BMS quality team worked with all GxP domains to understand their review and approval processes and replace their local SOPs with global policies and procedures. The team also provided dedicated support to their users who were at different maturity levels along the change curve. Establishing standardized workflows across GxPs, BMS improved operational efficiency, reduced 100+ procedures across functional areas, and achieved a 50% reduction in workflow roles. View their presentation here. (Non-registered users can get access here)

GSK: Increasing collaboration and compliance with global document management
In their presentation, GSK discussed their approach to simplifying and modernizing global document management. With more than five million controlled documents stored across multiple legacy systems, GSK needed a modern digital platform that would improve user experience and provide various options to share content across the organization. “We found that users were navigating across different applications and experiencing delays when searching and printing documents,” said Marcus Massingham, senior director of quality systems at GSK. “We consolidated all GxP and non-GxP content in a single modern document management system, achieving 60% usability improvements, and improving system responsiveness by 75%.” See GSK’s presentation here.

Gilead: Increasing manufacturing agility through improved partner collaboration
Gilead shared their quality modernization and expansion journey to support multiple acquisitions and rapidly expanding manufacturing network. Leveraging the same Veeva Vault for internal and external documents, the company streamlined information exchange across 130 contract manufacturing and contract test lab partners. “A single user interface, automated user provisioning, and combined security management have dramatically simplified content management for our users and our partners,” said Jennifer Trundle, director of quality management systems at Gilead.

The company also selected Veeva Vault QMS to transform quality management. “We plan to support our rapid growth in manufacturing and oncology by standardizing quality processes in a single modern, easy-to-use cloud solution,” Trundle said. View their presentation here.

Dicerna: Optimizing business processes with unified quality
Dicerna shared how they unified and optimized core quality processes like GxP training, deviation, CAPAs, and change control across all departments. Three years ago, the company began to grow and needed to replace their paper-based system with a scalable cloud platform to achieve better quality outcomes. “Our goals were to improve efficiency, oversight, and decision making,” said Anthony Davis, sr. director of quality assurance & compliance at Dicerna. “We reviewed the efficacy of our processes through the lens of inspection readiness, quality performance, and oversight, and eliminated several non-essential steps.” View Anthony’s presentation on unifying and connecting quality here.

Watch these and other sessions on demand. If you haven’t registered yet, gain access here.

The post Transforming Quality Across the Enterprise: 2020 Veeva R&D and Quality Summit Highlights first appeared on Veeva.

The accelerated uptake in digital channels such as remote meetings and rep-triggered emails¹ over the past few months compel life sciences companies to deliver more personalized and impactful content faster.

Combining your medical, legal, review (MLR) process with your digital asset management (DAM) solution not only allows your company to adapt to these increasing demands for content but also streamlines workflows, maximizes its breadth, and addresses compliance.

Here are three ways best-in-class life sciences companies benefit from a combined MLR and DAM solution:

1. Improve collaboration across a decentralized organization

Roche’s merger with Genentech was the catalyst for a centralized content strategy model. Although the two companies continue to operate as separate entities, they realized they would benefit from having a centralized solution globally, and across brands.

“Imagine a world where we have a single source of truth, and that we can adjust content depending on the customer and market,” said Samantha Knott, global customer operations leader at Roche. “This was our vision for Roche and Genentech, and where we’re heading.”

With this strategic initiative, Roche and Genentech now benefit from harmonized processes, improved collaboration across multiple stakeholders, and a more consistent insight gathering approach.

2. Adapt to the ever-evolving customer journey with content tracking

An interconnected customer engagement solution provides a holistic picture of the content journey, from creation, review & approval, and multichannel distribution. Merck KGaA, Darmstadt, Germany, had this in mind when they created their “Trace n’ Track” program.

The program allowed Merck KGaA, Darmstadt, Germany, to manage content in a compliant and consistent way, enhancing content reuse and faster time to market.
Fabienne Vanderpoel, senior director of business optimization at Merck KGaA, Darmstadt, Germany, says, “With the right content journey, you can trace your material from global creation to local customer engagement. ”

3. Drive better customer experience and global-local brand consistency

“Think global, execute local” is what LEO Pharma had in mind to align creative local content initiatives with global brand guidelines and strategy.

To achieve this, LEO Pharma built an integrated digital ecosystem to globally manage its content and engagement channels. This solution and the global messaging framework they made allow markets to creatively adapt their content to the customer needs while remaining on-brand.

“Our solutions at LEO Pharma are integrated so that we can track customer engagement across channels,” said Kasper Jerlang. “This allows us to create better customer experiences through personalization, increased compliance, and brand coherence.”

Bayer, GSK, and Merck KGaA, Darmstadt, Germany will share commercial content strategies, learnings, and best practices at the 2020 Veeva Commercial & Medical Summit Online, Europe. Sign up now.

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^{1 Veeva HCP Pulse. Veeva Systems. September 2020}

The post 3 Ways Combined DAM and MLR Drive Success in Roche, Merck KGaA, and LEO Pharma first appeared on Veeva.

Greater than 90% of events conducted since April 2020 are virtual. Customers often ask, “how do I differentiate our virtual events? I need a playbook that guides us on how to host the best virtual events.” In a recent blog, we’ve identified five considerations to execute an immersive event experience. Here’s the next-level detail for the first key consideration: rethink the format of your events. What does it mean to have a well-architected event?

While it’s essential to experiment with different virtual event formats to help overcome the two-dimensional fatigue, pick one or two types and become masters at those events. Format examples include:

On-demand content

• Build on-demand content for easy access to short pre-recorded presentations (e.g., 20-30 minutes).
• Offer ongoing live Q&A sessions, with multiple dates/time options, where HCPs can register and actively participate at their convenience.

Virtual presentation followed by breakout sessions

• Virtual events provide the ability to break out into smaller groups quickly and allow for more in-depth discussions, increasing overall engagement. Assign a group leader in advance to ensure meaningful conversations.
• Allow enough time for the breakout groups to reconvene and share highlights.

Hybrid events (multiple variations combining virtual and in-person events)

• Requires an infrastructure that can support multiple remote participants – including HCPs gathered in an office setting, groups of remote sites, or individual HCPs participating independently from their home.
• Hosting hybrid events will require more resources as you need to accommodate both in-person and virtual needs.
• HCPs will expect flexibility in having options for participating in an event (i.e. from home, office, or remote site).

A successful event is based on the quality of attendees, level of engagement, and overall seamless experience for the HCP. Set clear goals and continuously refine your events strategy to improve the quality of your events.

Want more tips for transforming your digital events? Read about the five ways to execute an immersive event experience.

The post Transform your digital events: Rethink the format first appeared on Veeva.

We were honored to welcome nearly 800 people to the clinical operations track at this year’s Veeva R&D and Quality Summit Online. Industry experts from eight life sciences companies – both small and large – shared their experiences streamlining clinical operations to increase efficiency, quality, and speed in clinical trials.

Modernizing Clinical Trials

Anders Persson, a digital transformation leader at AstraZeneca, kicked off the clinical operations track by detailing AstraZeneca’s multi-phase deployment and change management program to transform clinical trial operations globally – across 40 countries and 3,000 users, with eight million records migrated for 1,350 studies – in 16 months. They outlined their vision, strategy, and implementation approach as well as the positive impact of a unified clinical landscape on global study execution.

As highlighted in the Veeva 2020 Unified Clinical Operations Survey Report, unifying clinical operations is a top priority for improving trial performance. This view was echoed by Marc Nephtali, Jessica Skrine, and Garrick Myers from Vertex Pharmaceuticals, who modernized its operating model by unifying clinical systems throughout the enterprise. They shared Vertex’s complex and accelerated implementation timeline, key measures of success, and lessons learned along the way.

Jess Robinson from GSK discussed the importance of aligning people, processes, and technology to achieve a unified clinical environment and speed study execution. Jess shared change management techniques that enabled a successful global launch of Vault Study Startup and best practices for managing multiple Vault applications.

Active TMF Management

Summit attendees heard about the benefits of active TMF management in improving TMF quality. Leila Ponce, clinical trial manager from Seagen, explained how metrics, dashboards, and reports built within Veeva Vault eTMF are used to maintain an ongoing culture of inspection-readiness, and subsequently, helped the TMF team prepare for, and pass, an inspection.

Jessica Vicari, director of clinical digital solutions from Immunomedics, shared their best-in-class TMF management processes and how they used a people-process-technology framework to enhance their TMF operations.

Leveraging Vault eTMF to streamline TMF processes and improve inspection readiness was a priority for JC Sheridan and Heather Frankhouser from Janssen. By bringing together both essential and non-essential trial documents that were previously managed across multiple systems, they were able to more clearly tell the full story of a trial.

Streamlining Information Sharing and Collaboration

Current technologies provide the opportunity to transform trial execution through simplifying and streamlining the flow of information between studies partners, as Julie Saathoff, executive director at Celerion, elaborated. As an early adopter of Veeva Site Connect, Julia discussed their vision to streamline how information is shared during clinical trials. She outlined how Celerion is leveraging Site Connect to eliminate manual processes, improve study quality, and increase site engagement by automating the flow of trial information across systems, processes, and study partners.

Jeff Wiley, head of global clinical project delivery at Covance, broached the difficulties in monitoring and source data verification (SDV) activities once COVID-19 hit. He spoke about how they dealt with this situation specifically, encouraging their sites to use Veeva SiteVault to not only manage site processes but also support easier remote monitoring and document transfer during the study. This allowed Covance to keep their trial on track with minimal delays, despite the challenges posed by the pandemic.

This year’s Summit encouraged peer learning and focused on thought leaders in clinical trial operations. We’re looking forward to seeing how this collaboration and knowledge-sharing drives the industry forward in the coming months. To view the presentation portion of these sessions on-demand, please register here.

The post Trial Efficiency and Collaboration Key Topics at 2020 Veeva R&D and Quality Summit first appeared on Veeva.

As a global pharmaceutical company, Eisai manages thousands of medical inquiries about their commercial drugs and emerging research. After using disaparate medical information databases that couldn’t scale, they identified the need for centralized medical information to create consistency across the regions and affiliates and a more robust audit trail.

In a recent webinar, David Robertson, business solutions director for Eisai EMEA, and Elizabeth Rance, head of medical information for Eisai EMEA, shared why they selected Veeva Vault MedComms for medical information management and their experience to optimize their medical information, processes, and technology, especially during the COVID-19 pandemic.

“We have really all been affected by COVID-19 and it’s caused us to think very differently about the way our business is going to work in the future. So, we’re very concentrated on global digital transformation,” says Robertson.

Laying the Foundation

Once the technology decision was made, Eisai decided to implement the system in several phases. Phase one focused on their UK European Knowledge Center to establish the foundations.

“We wanted to ensure that we had a strong base in the UK to build on,” says Rance who oversaw the implementation.

Rance discussed how laying the foundation in phase one helped the team refine the process, learn from the experience, and feel confident in their approach before deploying across EMEA in phase two.

The phase two regional deployment will satisfy all the local requirements in each of the countries and build their centralized system across EMEA in order to roll up reports to leadership and increase their efficiency and compliance as a team.

A Single Medical Information Management System
Robertson shared how they historically experienced inconsistencies and a lack of transparency with medical inquiry responses at the affiliates and that multiple databases lead to duplication and manual tracking of content.

By replacing disparate systems and workflows with a single source of truth for medical information, the team ensured that headquarters and affiliate teams not only have accurate content and a clear inquiry response process, but also a robust audit trail for traceability to reduce compliance risks.

“We wanted a system that would give us a holistic approach to managing medical information inquiries,” noted Robertson.

Intelligent Insights to Make Informed Decisions
With Vault MedComms reporting, Eisai has the ability to understand how teams are managing medical information inquiries and what content is most utilized. “We worked hard with Veeva to make sure we had the type of reporting and insights that brought value to our business,” shared Robertson.

The team reports on questions asked, product inquiries, and what country the inquiry is from. This reporting gives leadership the insights that help them make continuous improvements in their medical information management operations.

Learn more about end-to-end medical content management here.

The post Eisai: Laying the Foundation for Centralized Medical Information Management first appeared on Veeva.

This year’s safety track at the 2020 Veeva R&D and Quality Summit focused on streamlining and collaborating. With many people working virtually, making processes easier across teams and partners is critical.

The opening Veeva keynote with Kelly Traverso, VP Vault Safety Strategy, outlined the Vault Safety vision of building a modern and unified solution that provides real-time visibility into safety data. The current pharmacovigilance system architecture is fragmented and, in some cases, outdated. Requiring significant upgrades, it is a strain on resources and budgets.

A unified pharmacovigilance solution simplifies processes and provides better visibility and traceability of safety data. To learn more on unified safety, download our infographic.

There was also a sneak peek of the upcoming Vault Signal product. As part of the Vault Safety Suite, Vault Signal will manage signal detection through risk evaluation and mitigation.

G1, a Vault Safety customer, discusses how integrating Vaults can further streamline pharmacovigilance processes. Their Vault MedComms and Vault Safety integration will allow adverse event data collected in the call center to be immediately visible to the safety team – eliminating duplicate data entry, allowing tracking of adverse events back to the original call, and reducing data reconciliation. It is “a huge step forward in terms of efficiencies for case processing and reporting of safety data,” said Richard Dyer, senior information technology solutions architect, G1 Therapeutics. Vault Safety is also making it easier for G1 to work with their CRO as all parties have direct access to case data. With Vault Safety, the G1 safety team does not have to wait for information from their CRO and are able to easily find and address erroneous, duplicate, and other data issues.

CROs provided their perspectives on collaborating with biopharma companies and Vault Safety in the panel session. With recent changes in work environments, ease of working across geographies became important. Catalyst and Arriello found Vault Safety easy to use for administrators and end users. They are able to easily onboard clients – anywhere – and share information and collaborate. Bringing on existing Veeva customers of other Vault applications was even faster as they are familiar with the solution. The system is also flexible said Catalyst’s application admin, with “high configurability without high complexity,” according to Lisa Hornick, M.D., chief medical officer, Catalyst Clinical Research.

There was a lot of interest in connecting Vaults and Veeva provided an overview on the approach. We looked at how connections are enabled by Veeva Vault Spark and potential use cases for integrating Vault Safety with the following Vaults:

• Vault eTMF to streamline management and distribution of safety letters
• Vault EDC to provide real-time visibility of adverse events collected from sites
• Vault CTMS to eliminate duplicate data entry. Vault Safety will share product information and Vault CTMS will provide visibility into trial information such as sites, study arms, and investigator information
• Vault MedComms for automatic transmission of AE data for processing

Over the two-day event, best practices regarding implementation and migration were shared by NNIT and Veeva. NNIT has extensive Vault migration experience and discussed essential ingredients for success, and considerations for migrating safety data. The Veeva services presentation focused on implementation best practices and explained their holistic approach, implementation risks, and ways to mitigate them. They also reviewed implementation accelerators such as best practice methodologies, templates, and validation kit.

If you missed one of the sessions or would like to see it again, please click here to view the recordings.

The post Safety Track Highlights from 2020 Veeva R&D and Quality Summit first appeared on Veeva.

At this year’s 2020 Veeva R&D and Quality Summit Online, we heard how emerging biopharma companies are centralizing regulatory information, streamlining processes, and establishing a solid foundation for growth.

Rusty Ang of SeaGen described how the fast-growing company replaced email, spreadsheets, and file shares with a single system for managing submissions, health authority interactions, registration tracking, and published dossier archiving and viewing. He was joined by colleagues H Bondar and Verchel Wunpheng, who each shared lessons learned from their Vault RIM implementation, including strategies to improve user adoption and manage the migration of existing documents and data. Lastly, the SeaGen team provided a look ahead into their plans to implement cross-Vault connections for regulatory, clinical, and quality.

In a follow-up to last year’s Vault Submissions Publishing panel, Veeva welcomed back Anthony Ochoa from Myovant along with Lisa Pitt and Ayesha Ullah from Viela Bio and Jason Maze from Dermavant. They discussed how a continuous publishing approach creates process efficiencies and provides real benefits for smaller teams looking to advance regulatory operations.

Attendees also heard from Craig Gassman of Vericel who shared five simple configuration updates for Vault Submissions that put more information at users’ fingertips. The updates—all driven by user feedback—include a dashboard that provides one-click access to commonly retrieved documents like correspondence and approved labels.

Matt Neal from Atara Biotherapeutics explained how Vault RIM has evolved into a platform for growth and competitive advantage, simplifying the day-to-day work for integrated regulatory teams. Neal also advocated for risk-based validation to promote agility and accelerate the delivery of business value to end users. In the same session, Scott Cleve laid out bluebird bio’s plans to leverage more of Vault RIM’s capabilities that go beyond document management. The initiative will transform Vault RIM from a “place to upload documents” to a strategic asset that supports regulatory processes and decision making.

Arcus Biosciences closed out the regulatory track by detailing their journey from a disjointed environment of email and SharePoint sites to the company’s first-ever validated RIM system. Patty Carlos, Lisa Owens, and Mike Tarsa reviewed their considerations for IT infrastructure, business processes, system configuration, validation, data migration, and training.

Thanks to our presenters for sharing their experiences and insights. To view these and other Summit sessions on demand, please click here.

The post Innovative Companies Share their RIM Strategies at Veeva R&D and Quality Summit first appeared on Veeva.

Much to the excitement of migraine sufferers, Nurtec™ ODT was approved by the FDA in February 2020. As Biohaven prepared for its first commercial launch, COVID-19 changed everything. Chris Deluzio, senior vice president of sales and commercial operations for Biohaven and an industry veteran with over 23 years’ experience, acknowledges the challenge the neuroscience sales representatives faced with their first launch. “COVID-19 is something the world has never experienced in our lifetime. We asked ourselves how to adapt our approach to get patients the help they needed and physicians the product they wanted.”

Biohaven’s Deluzio offered four key areas to consider when developing a digital engagement strategy:

1. Meet the customer where they are

Biohaven changed its deployment approach to align with new market conditions, changing physician behavior, and shift to virtual meetings. “As it relates to our activity in HCP engagement, we focused on meeting the customer where they are and reframed the expectations related to call plan, reach frequency, and activity. Our expectation for the sales force to deliver an excellent customer experience, specifically in clinical data, didn’t change, the way they told the Nurtec™ ODT story for a virtual engagement did.”

2. Rely on data to make decisions

With COVID-19, Biohaven adopted an agile, data-driven approach to their sales strategy. The company leveraged Veeva CRM to better understand regional engagement trends and capture physicians’ preferred communication methods to create personalized communication plans. Deluzio explained, “Probably the most important data we attained in this process was from our reps. One thing we consistently say at Biohaven is, we need to meet the customers where they are. We took an opportunity to leverage our neuroscience sales specialists, and the data they were gathering to learn which physicians were willing to engage in a virtual meeting.”

3. Implement sales training and regular sales team communication

Because digital communication methods may be new to your sales teams (and HCPs), offering more sales training opportunities is essential to increase confidence and success. Biohaven’s sales training included best practices for video communication effectiveness, including effectively communicating by focusing on the camera and creating passion and excitement through a virtual platform.

Biohaven also created an internal communication strategy to ensure sales reps understood the new sales vision and were aligned. “Putting together a communication package around the vision, and sharing the roadmap consistently over time has been where we’ve been able to get the sales buy-in. With this virtual environment, we flipped what a traditional rep would have done. If we didn’t have their buy-in along the way, we would not have been successful and had the impact that we did,” Deluzio explained.

4. Aim for agility, not perfection

Agile sales planning and execution focus on rapid iteration rather than perfection. Not every strategy will succeed, but the important thing is to create a culture of innovation where new ideas are welcome and tested. Biohaven found that an agile approach allowed them to test and refine sales processes quickly. “We continue to assess and make changes where we need to. I found that we do not need to be 100% with our plan…80% was good enough. We didn’t compromise anything significant enough to be a detriment or force us to take multiple steps back. Speed is important, and perfection is great, but in this environment and how quickly it’s changing, 80% was good enough for us.”

Prepare for the Future
Like many companies, Biohaven believes it is unlikely sales teams will return to a 100% in-person sales strategy after COVID-19 is resolved. “Customers are telling us, ‘I don’t know that I’ll go back to how I practiced medicine before COVID-19. I like this engagement. I feel I can still get that connection with my patients. And more importantly, I still feel I can get that connection with my pharmaceutical reps while always meeting our customers where they are in their preference and readiness,’” Deluzio stated.

While no one can predict precisely how the future will look, it’s clear the shift to digital isn’t a temporary tactic but a long-term strategy. The good news is you don’t have to do it alone. Veeva Systems can help you continue to adapt with solutions, services, and best practices for optimizing digital engagement.

The post Going Digital: Four Considerations for a Remote Launch first appeared on Veeva.

The United Kingdom formally left the European Union on January 31, 2020, and we are quickly approaching the end of the Brexit transition period on December 31, 2020. Because Brexit impacts every sponsor that has marketed products in the EU and wants to continue marketing them in the UK, the Veeva team is working with customers to ensure they can manage this transition seamlessly.

The first major milestone that sponsors need to consider is that MHRA is converting all existing Centrally Authorised Procedures to UK applications on January 1, 2021. Sponsors will then need to submit an initiating sequence (representing the currently authorised product), a list of historical regulatory activity, the SmPC, package labels, and leaflets to the MHRA by January 1, 2022. All products approved in the UK via MRP/DCP will remain valid and receive a UK MA number on January 1, 2021, but sponsors need to remove the UK from the MRP/DCP prior to that time.

In addition, for all EU procedures, the Marketing Authorisation Holder (MAH), Qualified Person for Pharmacovigilance (QPPV) and Pharmacovigilance System Master File (PSMF) locations must reside in the EU. If marketing in the UK, the MAH must be located in the UK by January 1, 2023. The QPPV and PSMF location may be in the UK or EU, but if the QPPV is in the EU then the MAH must nominate a national contact person.

Organizations that manufacture medical devices should also be aware that the CE mark will only be recognized by MHRA until June 30, 2023. After that time, the UKCA mark will be required. Starting on January 1, 2021, all medical devices and IVDs placed on the UK market will need to be registered with the MHRA, although there will be a grace period for registering depending on the classification of the device. Foreign device manufacturers will need to establish a UK Responsible Person by January 1, 2021 who will be responsible for acting on behalf of the manufacturer, including registering the device with MHRA.

Below is a summary of the Brexit timelines:

Veeva will continue to monitor changes in this area and work with sponsors to overcome the challenges that evolving regulations can create. We will provide our Veeva Vault RIM customers with guidance and best practices for compliance, and we will empower them with the information they need to take action in a timely manner.

To see how Vault RIM helps sponsors streamline global regulatory processes, watch this six minute product demo.

The post Tips for Managing the Brexit Transition Within Your Organization first appeared on Veeva.

In a recent Veeva survey, 47% of pharma and biotech professionals claimed that personalized content and experiences are a top content priority. To differentiate your virtual event, focus on personalization and, more importantly, elevate your content.

How do you elevate content? Here are three considerations:

Pre-event prep work
Especially for virtual events – it’s no longer about the number of attendees – it’s about having the right group of HCPs that will engage in a meaningful discussion. Elevating content is not just about delivering insightful information to attendees. It’s also about the broader conversation and shared experiences around the topic. Spend time thinking through which HCPs will actively participate and benefit from the event experience.

New styles to deliver insights
HCPs have expressed fatigue over the surge of webinar invites they’ve seen due to COVID-19. They miss peer-to-peer interactions they would typically experience at in-person events. Use that gap as a leverage point to differentiate your event—host breakout sessions to promote colleague discussions and audience engagement. Consider delivering insights through other non-traditional formats such as gamification or workshop-style events. Exploring new ways to provide insights can help combat virtual meeting fatigue.

Content Reuse
Part of elevating content means that the information is shared beyond the event experience and put into practice. Build on the educational content delivered at the event so that HCPs can fully internalize the information. Eighty-six percent (86%) of marketing, IT, and commercial operations professionals say they are producing more content now than six months ago. Utilize a platform to create and streamline the delivery of relevant information across multiple channels.

To enable an immersive experience for HCPs, offer a content experience beyond a one-time presentation given by a speaker at an event. Consider sending follow-up materials as part of a broader strategy to communicate relevant insights on an ongoing basis.

Want more tips for transforming your digital events? Read about the five ways to execute an immersive event experience.

The post Transform Your Digital Events: Elevate Your Content first appeared on Veeva.

IDC Health Insights predicts that by 2022, 30% of life sciences companies will achieve data excellence, which is defined as “the concept of effectively using the right data at the right time.” How can organizations that are early in their data management journey work towards this vision?

We spoke to Scott Brannigan, Head of IT at Immunomedics, about what he learned from leading grassroots efforts to define their data management strategy before the launch of their first product. Here are some of his recommendations for early-stage life sciences companies looking to establish a strong data foundation for commercial operations and insights.

First: build a core set of capabilities to drive other decisions. It is critical to determine the overall strategy from a platform and information capability perspective. Focus on getting the foundation right, knowing that it will grow and advance over time. Without a well-defined strategy, companies will inevitably face data management challenges in the long run.

Second: prioritize change management. Don’t underestimate the change management necessary as new capabilities are introduced. Collaborate and partner with the business on mutually agreed goals, such as cultivating a data-driven culture.

Third: take advantage of a pre-integrated solution. Integrating multiple solutions from different vendors into a homegrown platform is a time-consuming, resource-intensive, and expensive endeavor. Integration points are often weak points in a company’s data management strategy.

Fourth: expect change and maintain flexibility. Companies must be flexible in their approach as outcomes will undoubtedly be different than expected, either from a business perspective as they enter a market or from a technology perspective as they implement their data management solution.

Fifth: choose the right partner that is invested in your business needs.

“The right partner really wants to listen, understand your business, and help you achieve your goals. My strongest strategic partner is Veeva,” said Brannigan.

Watch this video to learn more about Scott’s recommendations and explore the Veeva Nitro product page to see the benefits of a pre-integrated commercial data management solution for life sciences companies embarking on a data management journey.

The post Immunomedics' Top Five Tips in Starting your Data Management Journey first appeared on Veeva.

The MedTech industry is changing with today’s regulatory professionals at the center of this evolution. For most, managing regulatory activities creates several challenges: struggling with poor data quality, duplication, and limited visibility as a result of disjointed processes and a myriad of tolls for each task. Add in new regulations like EU MDR and IVDR with a global pandemic and the complexity is compounded.

This is why executives from leading device and diagnostics manufacturers came together at Veeva Summit to share their successes and best practices for modernizing regulatory technology and processes. The ability to innovate while complying with ever-changing requirements proved to be a consistent theme across the board, including:

• Harmonizing regulatory operations
• Enabling better compliance
• Providing a single source of truth
• Streamlining and measuring success

Harmonize Regulatory Operations

The introduction of cloud-based Regulatory Information Management (RIM) systems have enabled companies to harmonize their regulatory functions, globally, and move with greater speed. Moving away from manual processes with limited visibility to utilizing systems that create transparency and the ability to share real-time data is resulting in more efficient submission development, better compliance, and speed.

At Summit, Baxter Healthcare shared their RIM implementation best practices and approach to modernizing regulatory operations. The speaker outlined the company’s project scope, guiding principles, and measurements of success for how RIM centralized regulatory operations into one tool and is part of a larger ecosystem of data and documents.

Enable Compliance

Complying to regulations is an on-going challenge for most companies. When operating with outdated tools and processes, the risk of a mismanaged process can lead to serious financial penalties, product delays, and a tarnished corporate reputation. Fortunately, advanced technology enables regulatory professionals to keep up with a growing amount of global information, quicken the pace of change, and collaborate with more people. As highlighted by Alcon and others at Summit, a unified RIM platform facilitates better access, visibility, and control over regulatory documents and data processes in real-time.

Single Source of Truth

Regulatory teams across an organization need to be connected throughout the product lifecycle by maintaining a single source of truth that feeds critical commercial processes. With regulatory teams tasked with managing ever-increasing volumes of information, including promotional materials, the stakes are too high for errors associated with misinformation across multiple siloed systems.

Adopting a single, connected commercial application as a “source of truth” was echoed throughout Summit as a solution to ensure teams collaborate on the latest version, shorten regulatory review times, and bring a compliant message to market with speed unparalleled to previous disconnected systems.

Roche Diagnostics elaborated on this by sharing best practices to implement and utilize technology for a single, connected source of truth with better compliance and acceleration of the digital supply chain process of creating, approving, and distributing commercial content across their organization and digital marketing channels.

Streamline and Measure

A unified RIM solution empowers organizations to work smarter by streamlining processes and measuring tangible results. We heard this loud and clear from GE Healthcare, who shared how a cloud-based solution allows their leaders to easily identify bottlenecks with a full 360 degree view into the process. Previously, leaders knew there were inefficiencies but had no visibility into the impact or where to target a remedy. With RIM, management at GE is now able to quickly pinpoint inefficiencies and pivot strategies targeted at the biggest impact.

Reiterated by other device and diagnostic companies, a modern RIM solution also reduces administrative burden and frees up valuable resources for more value-add tasks. GE demonstrated this case by sharing how their affiliates now access one system to update data, rather than previous methods of filling out a form and emailing to HQ for data entry.

The bottom line is it’s critical for companies to reduce complexity, streamline regulatory operations and compliance processes, globally, to stay competitive. To learn more and watch on-demand sessions from companies leading the way in modernizing regulatory, register here.

The post Four Key Areas To Streamline Regulatory Operations and Compliance first appeared on Veeva.

EMA’s Clinical Trial Regulation (CTR) aims to create an environment that is favorable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information. With CTR, the assessment of clinical trial authorization will be done in two parts. The Part I assessment is performed by a single, designated member state (reporting Member State) who evaluates compliance with the regulation and completeness; Part II is done by each of the Member States where the clinical trial will be conducted to assess compliance around local legislation with respect to informed consent, compensation of subjects and investigators, suitability of sites, ethics, etc.

Mandating the submission and review of all common trial data to a single reporting Member State increases efficiency for trials conducted in multiple Member States in Europe. The key benefits of the regulation are expected to include:

• Harmonized electronic submission and assessment process for clinical trials conducted in multiple Member States
• Improved collaboration, information-sharing and decision-making between and within Member States
• Increased transparency of information on clinical trials
• Highest standards of safety for all participants in EU clinical trials

This process will be facilitated by EMA’s Clinical Trial Information System (CTIS), which will be the single entry point for submitting clinical information in the EU. The system includes three central areas:

• Sponsor workspace – assist sponsors in preparing and compiling data to submit to the system for assessment by Member States
• Authority workspace – support the activities of Member States and the European Commission in assessing and overseeing clinical trials
• Public website – allow the public to access detailed information on all clinical trials conducted in the EU, in all official EU languages. EMA will make information stored in CTIS publicly available subject to transparency rules.

The planned timeline for the CTR is as follows:

While it’s clear that the new Clinical Trial Regulation harmonizes the process for assessing and conducting clinical trials in Europe, it may also blur the lines of responsibility between different functional areas within the sponsor’s organization. CTR creates a unique opportunity for sponsors to rethink how they manage data and documents. Traditionally, planning, managing, and conducting clinical trials sits within the clinical domain, while the submission of data to attain approval and ensuant interaction with health authorities is the responsibility of the regulatory organization. However, the new regulation may encourage sponsors to re-evaluate the value of this approach.

CTR does not mandate a submission in the traditional sense, but rather it requires sponsors to upload clinical documents and data points into CTIS, which in lieu of interfacing capabilities is a manual process. Since the vast majority of data and documents that govern this process are generated throughout the lifetime of the clinical trial, it may be more efficient for the clinical domain to own the interaction with CTIS directly.

To learn more about how Veeva helps customers adapt to evolving regulations, check out these tips for managing the Brexit transition.

The post Assessing the Organizational Impact of EMA’s Clinical Trial Regulation first appeared on Veeva.

Veeva hosted a panel discussion with several pharmaceutical companies to understand how they’ve adapted to the new post-COVID reality. They provided five recommendations to help companies create a successful digital sales strategy.

1. Personalize interactions for higher quality engagement
   Consider shifting from a product-focused sales approach to a customer-centric approach. Russ Larson, an associate director of sales solutions from Merck, explained that his organization experiences a significant difference in the quality of provider conversations using virtual meetings. “Any company that’s using virtual sales meetings has probably seen an immediate shift towards a customer-centric engagement approach, as opposed to product and brand-driven conversations. I think we’re seeing that shift occurring immediately. It is less about producing new information on ‘product X’ that might benefit your patients because that will come naturally.”
2. New channels require new skills
   A critical component of a virtual sales strategy is ensuring your sales team can access the proper training materials and understands digital selling nuances. Rob Kauffman, AstraZeneca’s senior global business relationship manager, suggests incorporating role-playing into virtual sales tool training. “The most important step out of all the digital sales tool training is role-playing. Each sales rep needs to take turns role-playing the provider and the presenter personas. Role-playing is very important, especially when it comes to any kind of technology troubleshooting with the customer. As the final step, we have the sales manager participate in role-playing, taking on the provider persona. This acts as a certification step to ensure sales rep competency with the technology as well as the digital sales process.”
3. Virtual sales tools are not “just” a replacement for in-person meetings
   Larson believes that companies that embrace virtual meetings as a new form of communication, not just replacements for on-site meetings, will begin to see provider conversations with up to 5x longer meeting durations. “The other aspect of virtual meetings is you’re going to have more purposeful and deeper discussions. We shouldn’t think of Veeva CRM Engage Meeting as just providing the alternative to the in-person visit now that the COVID-19 situation is here. I truly believe that sales reps can have deeper, more meaningful conversations when providers are at their computers. With the move to more digital engagement, we’ve seen the average meeting duration increase beyond 20 minutes.”
4. Don’t let tech support distract from your meetings
   Because providers and office staff have varying degrees of technical understanding and experience, there is a likelihood of someone in the office needing help preparing for a virtual session. Darran White, Upsher-Smith’s manager of sales operations, cautions that it is okay to provide some basic troubleshooting help and advises sales reps to resist “playing IT technician” for providers and their staff. “Our reps shouldn’t be IT. Not every office has an IT professional that’s willing to troubleshoot if we run into an issue. One critical thing that we’ve always had is a backup in place. If something’s going on, the rep will go through some basic troubleshooting and send a prepared email that can direct the provider to additional troubleshooting resources. You do not want to lose valuable time towards troubleshooting a technical issue but also want to create a pleasant overall experience.”
5. Track meeting engagement metrics over time
   Life science organizations agree that adopting a digital engagement strategy requires new performance metrics to be analyzed. Top performance metrics to consider include sales team adoption of technology, provider engagement and re-engagement, and changes in meeting duration over time. Once you’ve measured how frequently digital channels are used, the next step is to understand what is happening during these digital interactions. For example, Veeva Pulse Data Trends show that 33% of Engage Meetings include remote sampling¹. This type of insight can help you learn and improve over time. If you need help getting started, subscribe to Veeva industry trends and compare your metrics to industry benchmarks.

Looking ahead
Companies are evaluating their post-pandemic sales meeting strategy. Most are already planning to use digital engagement solutions to enable a future hybrid sales strategy. “I think there’s going to be a continuation of in-person visits. I do believe that this hybrid approach of mixing digital capabilities with in-person visits is here to stay, and there’s no going back from that,” said Larson.

Combining digital tactics with in-person visits provide commercial operations leaders a significant opportunity to double the impact of their salesforce and provide a superior experience for HCPs. With the widespread adoption of virtual meetings, geographic borders disappear, giving reps an expandable call deck to go deeper and further in their region.

Take time to build a strong foundation for a virtual selling culture and ensure your business can maintain a competitive advantage within the market. Discover more best practices for optimizing digital engagement with Veeva CRM Engage Meeting.

^{1. Veeva Pulse Data Trends, Engage Meetings in the US, September 2020}

The post Five Strategies to Overcome Barriers to Physical Access first appeared on Veeva.

Life Sciences brands are redefining HCP communications in light of the COVID-19 pandemic. From February to November 2020, the number of Veeva CRM Approved Emails have increased by three times and field reps hosted 70 times more Veeva CRM Engage Meetings.¹

With this rapid shift in customer engagement practices, delivering capabilities to support the needs of a dynamic industry is critical. “Our dedication to product excellence and rapid innovation helps Veeva customers quickly deploy new digital capabilities and channels” said Arno Sosna, general manager of Veeva CRM. “We’re continually reimagining Veeva CRM to give customers a flexible solution that accommodates the way they work.”

Here’s a recap of five Multichannel Veeva CRM innovations that will help you drive better digital engagement and user experience.

1. Salesforce Lightning Business Apps for Veeva CRM

What is it: Veeva CRM Lightning Business Apps give users a personalized experience with functionality based on different roles and tasks. Veeva CRM provides four Lightning Business Apps to use and customize based on business requirements. Each app is included with the Veeva CRM license and contains default configuration for Tabs, Views, and Page Layouts:

• Brand Operations App: Provides insights into the brand, content utilization, and performance across channels
• Key Account Manager App: Focuses on Account planning and execution processes needed to manage key accounts across teams
• Pharmacy Sales App: Streamlines tracking, management, and execution of daily administrative tasks around the sales order process
• Primary Care Sales App: Supports the planning, execution, and analysis of the call and sampling processes

How this feature will help you: By providing tailored capabilities for different business users, the Lightning Business Apps improve usability and productivity. Here are three main business benefits:

1. Streamlined navigation: boost productivity with a workspace built to accommodate the way you work.
2. Role-based data visualization capabilities: focus on business insights that matter to your role to complete your tasks.
3. Enhanced flexibility for faster execution: save time with the ability to toggle between apps with ease.

Use case: 5-minute demo

Learn more about Veeva CRM Lightning Experience.

2. Veeva CRM Dynamic Attributes

What is it: Veeva CRM Dynamic Attributes enable business end users to quickly add new data fields in Veeva CRM and capture additional information about healthcare professionals and their organizations without IT support. The attributes display in a dedicated section on the account page layout, differentiating them from standard account fields.

How this feature will help you: This new feature empowers business users by eliminating the need to burden the IT team for support. Capturing account information, such as detailed targeting and customer segmentation, is easy and enhances go-to-market planning. Some use cases for which Dynamic Attributes will be useful:

• Feedback from a marketing campaign
• Quick survey/profiling question
• Metrics to be gathered as part of a new launch

Use case: 2-minute demo

3. Veeva CRM MyInsights Visualization Sharing

What is it: Veeva CRM MyInsights Visualization Sharing enables users to share MyInsights visulizations using iOS share actions.

How this feature will help you: This new feature allows end-users to share information from customized visualizations with people who do not have access to Veeva CRM. Below are three business scenarios where exporting the MyInsights visualization supports the rep’s workflow:

• Create a copy of your Territory Performance report: A commercial sales rep needs to share the current Call Plan page with her manager as part of an upcoming coaching session. She navigates to the MyInsights visualization that shows the Call Plan progress where she is able to print a copy to make notes and review in the meeting.
• Email a KOL profile to senior members of the organization: An MSL needs to share the profile of a Key Opinion Leader (KOL) with a senior member of the Commercial Team for an upcoming appointment they have with the said KOL. The senior member does not interact with CRM and just needs to view the KOL profile. The MSL navigates to the MyInsights KOL profile view and can easily email it to the senior member.
• Share Account Plan Progress for an HCO: A KAM manager reviews the Account Plan Progress visualization which shows top level progress metrics for a specific HCO. The KAM managers can save this view locally to an iOS file drive to use it in an upcoming business meeting.

Use case: 2-minute demo

4. Veeva CRM Approved Notes

What is it: Veeva CRM Approved Notes allows customers to monitor free-text fields, such as pre-call or post-call notes, for compliance purposes while enabling field reps to record detailed notes directly in Veeva CRM.

Approved Notes consist of the following processes:

1. Creating Monitoring Rules and Phrases: Compliance users define fields and phrases for monitoring.
2. Viewing Approved Notes Monitoring Results: Compliance users receive an email with results and metrics from the monitoring process.
3. Reviewing Violations: Compliance users review the notes text with violations and provide feedback on whether the violation is correct or not.

The compliant note-taking functionality is included in Veeva CRM.

How this feature will help you: By detecting compliance risks such as off-label messaging and inappropriate words, reps can build stronger customer relationships and drive more informed, compliant interactions.

Use case: 4-minute demo

Learn more by watching the full on-demand session “Approved Notes: Compliant Free-text Notes in Veeva CRM” from 2020 Veeva Commercial & Medical Summit Online.

5. Veeva CRM Engage Meeting: New Capabilities

1. Email Consent Capture

What is it: Users can choose between capturing an in-person signature or sending a double opt-in confirmation email to collect email consent.

2. Remote signature capture for sampling

What is it: Field reps can capture and fulfill HCP sample requests while hosting an Engage Meeting in compliance with 21 CFR Part 11 and PDMA requirements. Reps can confirm license and address information, validate sample details, and save HCP signatures as part of the call record. HCP signatures can be captured online across a mobile device or desktop.

3. Medical inquiry

What is it: Reps can compliantly capture signatures for HCP medical inquiries while hosting an Engage Meeting in compliance with 21 CFR Part 11 and PDMA requirements.

4. HCP experience rating

What is it: Attendees can rate their meeting experience, granting customers insights into the quality of the remote experience.

How these features will help you: By capturing remote consent and signatures compliantly, companies can deliver drug samples without the need for a face-to-face meeting. Reps can complete the same compliant process they would follow during an in-person meeting. HCP experience ratings enable customers to determine how remote interactions can be improved in the future.

Use case: 3-minute demo

Want to have a deeper look at these new features and see more use cases? Access the on-demand sessions from Veeva Commercial & Medical Summit Online until 8 January, 2021.

The post Top Features in Multichannel Veeva CRM You Should Use Right Now first appeared on Veeva.

What We Learned About the Digital Transformation from Veeva Medical Device & Diagnostics Summit

We have reached an inflection point within the MedTech industry where digital transformation translates to competitive advantage. Recognizing that well-embraced, quickly deployed, and easily maintained cloud-based quality applications can vastly improve both efficacy and efficiency, further quantifiable value can be had when these applications are unified within a single suite with the same underlying platform/technology. And the resulting efficiency gains translate to time that can be allocated back to the focus at hand – product quality, patient safety, and rapid innovation.

The presenters at Veeva’s Medical Device & Diagnostic Summit and their respective stories all share the same reverberation – one can see and hear the speakers’ passion for product quality and patient safety, and their recognition that their quality applications must be able to scale with them – in growth and in innovation.

Regulations and compliance serve as the guiding principles to the quality discipline. We were honored to have seasoned veteran Mike Baca, of industry stalwarts such as Johnson & Johnson, Medtronic, and Stryker, to speak to us about salient MedTech regulations that we operate within, day-in and day-out. In addition to the regulations, Mike shared his experience leading organizations through successful FDA inspections in his presentation: FDA Inspection Preparedness and Best Practices. The session contained the most memorable quote of the summit (in my opinion) – a humorously simple, yet impactful message of “if you didn’t document it, it didn’t happen”.

Building on that foundation, leading medtech companies discussed quality modernization efforts, operations best practices, transformational initiatives involving GMP expansion, and QA/RA connectedness. We also heard how a blisteringly fast implementation of Vault QMS supported an effort to save lives.

Through her presentation – Digitizing Quality to Drive Production Velocity During Public Health Crisis – Mary Ryan, Director of Innovation, Technology, and Regulatory Affairs at Penlon Ltd. shared how Penlon, along with a multi-national consortium of manufacturers, technology and services providers, came together to help build and deliver over 12,000 ventilators in record time for NHS as part of the VentilatorChallengeUK initiative. To achieve the velocity and quality required, Penlon and the consortium implemented and validated Vault QMS as an eDHR solution, in ten days’ time from start to finish, to help scale operations and meet their goals.

Establishing a quality center of excellence was the focus of a session presented by Tristin Wolff Cope, Regulatory Compliance Officer of Biodesix. She shared how Biodesix modernized its content management, by way of an acquisition, to a modern, cloud-based solution. Biodesix was able to quickly implement and adopt QualityDocs for all of its content management needs. Tristin provided insights into the implementation, shared her lessons learned with the audience, and her best practices on establishing a quality center of excellence.

Lee Young, Principal Consultant of Lee Young Consulting, provided his observations on the diagnostics industry in his presentation, Modernizing Quality Systems to Support cGMP Requirements. From changing regulations (e.g., IVDR) to increased reimbursement rates with top line revenue impact, there is an influx of diagnostics organizations – along w/ CLIA certified labs seeking to support GMP requirements – looking to modernize and get more value out of their quality systems.

Along the same vein, Mark Ramser, Sr. Director of Global Quality at Epredia, shared how Epredia leveraged a spin-off from Thermo Fisher as an opportunity to transform both quality and regulatory solution landscapes. Mark provided an inside look to Epredia’s drivers for change, its selection process, and future plans to connect its quality and regulatory functions through the Vault Platform to help maximize efficiency and increase value.

And last but not least, Adam Burgess, Director of Quality Assurance at Oval Medical Technologies, sat down for a virtual fireside chat to discuss their expansion into manufacturing and the importance of a modern, easy-to-implement, easy-to-use content management system to make that expansion a success.

While we all agree that compliance is the keystone at the crown of the “quality arch”, having a compliant solution simply isn’t enough in 2020. To learn more from these companies leading the digital transformation of Quality, watch on-demand sessions here.

The post Are Modernized Quality Applications a Predictor of Global MedTech Growth? first appeared on Veeva.

This is part one in a series about how collaboration can impact TMF quality and inspection readiness.

In the race for a COVID vaccine, we’re seeing amazing collaboration between the private sector, government, and academic research. Collaboration can become a force multiplier for speed and impact, leading to greater productivity, increased efficiency, and better outcomes.

If collaboration isn’t the heart of your solution, your organization will struggle as the trial landscape becomes increasingly complex. Pharma companies are spending more and more on partners and CROs. In fact, some sponsors are hiring multiple CROs to handle individual functions, such as one to execute the trial, one to monitor the trial, one for data management, one for feasibility and startup, etc. With so many hands in the cookie jar, driving collaboration among the increasing number of actors is critical to successfully conducting the study and maintaining the TMF properly.

The importance of the TMF on the outcome of studies is well understood. If trials take longer due to regulatory inspections or poor collaboration, it can significantly impact the bottom line. Some potentially blockbuster drugs could lose tens of millions of dollars due to these types of delays. We see TMF findings becoming more common as well as more severe. Simply having a TMF is not adequate. The quality of the content in that TMF is paramount and must be addressed across the board by all parties, not just individual contributors. This requires a coordinated joint effort as well as oversight, typically by third-party providers. The result should be a collective goal of stronger TMF quality overall throughout the course of a study.

Although managing this collaborative effort can take longer to create and maintain, the increased attention by all involved parties focuses and elevates its importance. The goal is to embrace and drive collaboration to put people in a position to succeed. Overall, the benefits can be significant. You’ll be able to improve inspection readiness, improve compliance, find and implement efficiencies, and maintain a higher level of TMF quality throughout the trial. Collaboration matters and can have a significant impact on your outcomes. Make sure your company is considering its impact and how you can start working towards better collaboration throughout.

So, how do we get there? In the second part of the series, I’ll talk about what steps organizations can take to increase their collaboration capabilities.

Watch this video to learn more about collaborating effectively to transform clinical trials.

The post Why Collaboration is Important to TMF Quality first appeared on Veeva.