Technology has transformed almost every aspect of our daily lives, yet site coordinators and clinical research personnel still rely on pen and paper to record patient visits before transcribing into EDC. Considering smart devices are nearly a decade old, it’s remarkable that critical patient information is first recorded onto paper rather than captured digitally.

The above estimates do not even include the cost of correcting the data, which is often incorrectly transcribed or not collected per the protocol. They also don’t consider the cost of onsite monitoring and source data verification (SDV), the process that checks the accuracy of the transcription. Onsite monitoring and SDV typically consume 14% of a study’s total budget¹, increasing the costs from paper data collection many times over.

Why hasn’t eSource taken off?
 
These many challenges, combined with the advancements in technology and increasing regulatory focus, naturally lead to electronic source (eSource) as the solution. Per the FDA, eSource is defined as “data initially recorded in electronic format…can include information in original records and certified copies of original records of clinical findings, observations, or other activities captured prior to or during a clinical investigation…”

eSource technology addresses data quality and productivity challenges by eliminating paper source and allowing sites to electronically capture and submit patient source data. Sites no longer have to spend days creating their own paper source documents, nor transcribe the collected data into EDC. eSource drives higher quality data through real-time data validation, preventing queries that typically occur when data is transcribed into an EDC application and the data is immediately available for review. Despite such benefits, eSource usage is still low and it has only been utilized in a fraction of studies.

This lack of adoption is even harder to understand when regulators have in recent years encouraged eSource adoption. The FDA promotes moving away from paper source in its 2013 electronic source guidance. Their final guidance on electronic source data in clinical investigations recommends elimination of “shadow CRFs.” The 2016 integrated addendum to ICH E6 also incorporates various approaches based on electronic data recording such as certified copies, ALCOA (attributable, legible, contemporaneous, original, accurate), and centralized monitoring.

So why is eSource adoption still so low? The biggest obstacle is that it is still very difficult to run an eSource-only study and in many studies, EDC is still required. In these situations, organizations have to work with separate EDC and eSource technologies. This immediately doubles the overhead: another software license, managing the design, build and validation of an additional application, trying to integrate these two disparate systems, and often provisioning device hardware for this additional eSource application. At the end of all this, study teams cannot expect real-time data access between two disparate systems.

eSource & EDC combined in a cloud platform

eSource and EDC need to be combined in a single platform to successfully drive the industry’s move away from paper as source. A combined platform allows study teams to perform just one design, build and validation for both EDC and eSource. This single build automatically generates tailored interfaces and workflows for sites, monitors and data managers. Study data is then accessible across the platform for instant review and decision-making without any integrations required.

Modern eSource and EDC combined should enable study builds in days, not weeks, through features such as simple ‘drag and drop’ user interfaces that remove the need for technical skills and programming. Review and approval times can be cut using configurable workflows using triggers and notifications to prompt activities – also giving project managers immediate visibility into any bottlenecks. The output is a dedicated user experience for each consumer/contributor, not a single view prioritized for one user community (e.g. Data Managers). As every site is different, with localized practices and requirements, modern eSource should enable sites to easily customize their electronic source forms to suit their workflow – without impacting the CRF data that the sponsor receives.

Intuitive eSource CRFs, with increased data collection guidance, reduce the number of queries and drive greater site protocol compliance. The data collected in eSource is immediately available for review and monitoring in EDC. However, this elimination of paper will naturally reduce source data verification and allow monitors to either consolidate onsite visits or focus onsite time on higher value activities, such as patient recruitment.

To learn more on this topic, please join us for our recent webinar ‘EDC and eSource: Combined for Better Data and Faster Insights.’ – you can access it here.

¹Clinical Trials, February 2016

Ms. Vernazza contributed to this article in her personal capacity. The views expressed are her own and do not necessarily reflect the views of Sanofi or Sanofi Genzyme.

Life sciences leaders are scaling medical teams to match the role’s expanded remit – a move that means increasing not only their size, but also their strategic scope. While our industry is making strides in expanding the number of medical science liaisons on the job, more work is needed on the second half of the equation: transforming the role itself and empowering MSLs to thrive in it.

Today’s healthcare landscape is incredibly networked, and HCPs face an acute need for timely answers to more complex scientific questions. Layer on the demands of transitioning to digital, and it is clear that field medical requires a shift in approach. Medical field-based teams should consider new processes enabling MSLs to reach the right stakeholders, quickly tailor engagement, and capture insights for more data-driven strategies. Fueled by a multichannel CRM systems designed for medical affairs, this represents a new way of approaching scientific engagement.

In my last post, I discussed key capabilities the modern MSL needs. But what steps can companies take to move forward, and what does the journey look like?

As medical teams evolve, they’ve uncovered best practices along the way that have smoothed the path toward thinking and working differently:

Creating a Culture of Change

Successful, strategic organizational change requires a high level of communication (early and often) to all relevant teams. Months before a roll out, start communicating about the change in order to foster high adoption when the system is deployed. Also, recruitment of a strong network of internal change champions is key. Digital-savvy end users not only help design the requirements and customize the build out, but also act as ambassadors for the impending change. They will talk with colleagues about the timeline, the benefits of the change, and what to expect. This way, all stakeholders know exactly who contact with questions and where to get updates.

Data-driven Planning and Engagement

Another success factor in implementing a new CRM is taking full advantage of medical data. With so much valuable information collected, how will it be used effectively to shape medical strategies? Using and analyzing data on customer interests and channel preferences, as well as leveraging reports and dashboards to evaluate performance of teams, is crucial. Taking hundreds of clinical insights collected in a CRM and performing data mining or text analytics to pull out scientific trends is extremely valuable. When MSLs start seeing this data, and uncovering insights that are immediately actionable, they get excited about building stronger relationships – in turn speeding adoption.

Leveraging the data in medical CRM, medical affairs teams can get a full picture of KOLs’ scientific interests in order to improve KOL engagement.

Key activity metrics can be viewed to determine resource capacity planning exercises and how to best grow field-based teams. For instance, if data shows MSLs are spending most of their time on internal activities, it signals a fundamental is needed with either team sizing or prioritization. At the end of the day, the value of technology is its ability to contribute meaningfully to business decisions.

The Right Foundation

Another key success factor is the ability to maximize technology to achieve medical goals without being burdensome for MSLs. Tool and systems should be as easy as possible for field teams, meaning the system has to work seamlessly from a technical perspective, with short data sync times, and proper alignment of stakeholders into their universe. Because MSLs spend so much time traveling in the field, the system needs to be intuitive – these teams don’t have time to waste figuring out software between meetings with stakeholders.

Beyond usability, it should be easy for MSLs to visualize the healthcare landscape as well as gain deep insight into each stakeholder, directly in their workflow. This level of visibility allows for faster and more strategic pre-call planning, as well as mapping strategies to account-specific objectives. Finally, tools should be easy for MSLs to capture information from interactions, across all channels, and refine engagement based on insights and analytics.

It’s an exciting time to be in medical affairs. Science is advancing every day, and field-based medical teams have the opportunity to make an impact in delivering better healthcare and improving patients’ lives. Realizing this vision means taking a look at how we approach our partnership with healthcare, adapting and growing with the evolution of our industry.

Ms. Vernazza contributed to this article in her personal capacity. The views expressed are her own and do not necessarily reflect the views of Sanofi or Sanofi Genzyme.

With medical affairs’ shift to a critical strategic function, the role is seeing tremendous growth – medical science liaison opportunities alone are expected to grow by 20% this year¹. However, this change also demands new skill sets and competencies. As the HCP-facing branch of medical, field teams are at the forefront. Today’s MSLs are essentially the CEOs of their territory, and a key local resource as the rare disease space continues to grow.

As MSL roles grow, companies can refine their approach to KOL engagement and MSL enablement and learn new ways to approach some relevant key areas – including the MSL role, digital strategy, and the building blocks of an effective field medical function.

Changing the MSL Role

MSL teams are expanding because they are increasingly relied upon as both the internal and external expert for the diseases they cover. Much of their time is spent working with and training internal sales, marketing and R&D teams on the medical education around these diseases. They can also be responsible for understanding the healthcare landscape, spending hours of prep time researching the publications, recent clinical trials, and scientific interests of key stakeholders. Beyond serving as an internal scientific resource, MSLs can be the voice of the HCP back to the company. This data generation is a unique resource that MSLs can deliver.

Cultivating Digital Savvy

More and more, digital and technology savvy is a core distinguishing factor of an effective MSL. As new tools emerge, such as medical-specific multichannel CRM, eMSL, MSL on-demand, and virtual meetings and events, MSLs are expected to be proficient in these technologies. Moreover, leading MSLs are helping to shape innovative use cases and digital strategy. Reliance on paper-based processes is declining as MSLs start realizing the benefits of leveraging technology to break down silos and improve transparency.

To meet the expanding demands of KOL engagement, medical affairs departments are rethinking how they engage, their core technologies and processes, and the core competencies of their departments.

Medical affairs will also need to have a more structured approach in planning for KOL engagements, as HCP time is limited and valuable. So leveraging HCP information captured in CRM, along with other external data, is crucial to tailoring communication. For example, we are now leveraging stakeholder data to segment thought leaders in a new and different way so that “rising stars” can be identified. This can lead to new relationships that possibly would have been missed entirely.

Additionally, the process of delivering scientific statements will also change as MSLs use iPads and other mobile devices to augment and capture feedback during face-to-face interactions. And even as access challenges proliferate, one can see a counter-trend of HCPs reaching out directly to MSLs, enabled by emerging virtual meeting and MSL on-demand technologies. This requires a mindset shift, but as seen consistently in KOL surveys, timely responses are extremely valuable to HCPs who have to make quick decisions about patient care. Instead of waiting for an MSL to visit, HCPs will more proactively reach out to get information these days – and expect to receive the right answer, regardless of channel.

Finally, the process of reporting back to the company with key field clinical insights and synthesizing these learnings will continue to evolve. Integrating field medical-derived insights with data from clinical trials and real-world evidence promises to be very powerful, and will ultimately improve outcomes.

Developing a Strategic Mindset

In addition to a scientific knowledge foundation, the capabilities to look for in MSLs are soft skill focused, such strong business acumen and emotional intelligence, sound judgment, integrity, self-motivation, and learning agility. They must also possess an entrepreneurial spirit and leadership presence, and be able to tell a compelling story with scientific data. MSLs are essentially managing their own territory like a mini-business so need to be able to think creatively, while strictly adhering to compliance guidelines and internal policies.

Within life sciences, strategic development and commercialization cannot fail to account for the value and insight medical affairs delivers. In my next post, I’ll explore how one can design a change management plan, and progress toward a vision of a fully empowered medical affairs function.

¹ “8 Reasons MSL Opportunities will Grow in 2017,” MSL Society.

Highlights from Veeva’s 2017 Unified Clinical Operations Survey Presentation at #DIA2017

Over 7,000 life sciences professionals from more than 50 countries came together in Chicago last week to discuss the future of clinical development and share their valuable experiences at the DIA 2017 Global Annual Meeting. The 53rd annual meeting provided a rare opportunity to meet people from around the world in an open exchange of ideas, research, and trends impacting the global life sciences community. Veeva was delighted to attend the conference and participate in the numerous activities and discussions taking place throughout the event.

In his DIA Innovation Theater presentation, Veeva’s Michael Burton presented the findings from Veeva’s 2017 Unified Clinical Operations Survey. As one of the industry’s largest global surveys, the research found that 99% of respondents see the need to unify clinical processes and systems for faster study execution, improved study quality, and lower costs.

Top Drivers of Unification

To the degree your organization needs to better integrate/unify the clinical applications identified in question 3 (e.g., CTMS, EDC, eTMF, etc.), what are the most important drivers? Select all that apply. (Q.5) Percent of total respondents, N=300

To help explain this concept of clinical unification, Michael used the analogy of shopping on an iPhone. Consumers research products, read reviews, view product videos, shop for the best price, and buy online in one seamless experience. At no point does the user need to log in and out of different applications. All the heavy lifting takes place behind the scenes on modern technology platforms, designed to provide the best possible user experience. This concept can similarly be applied to improve clinical operations.

Veeva’s Michael Burton explaining unification and delivering the findings of the
Veeva 2017 Unified Clinical Operations Survey

Take, for example, the current clinical ecosystem. Most sponsors report using an average of three to five different applications, each supporting a discrete area, creating information and process silos that prevent efficient study execution and severely limit study visibility. Unlike the seamless iPhone example above, most of the challenges sponsors face today in managing clinical trials stem from the disparate nature of their processes and systems. Nearly all survey respondents cited at least one major challenge with their clinical applications and the top two issues – integrating multiple applications and reporting across applications – are a direct result of system silos.

It is no wonder then that the study reveals universal agreement that organizations need to unify their clinical applications, including EDC, CTMS, and eTMF. The research finds that those who adopt modern, purpose-built applications report fewer challenges and see greater study benefits. And when unified, these applications enable life sciences organizations to establish repeatable, collaborative processes, and increase oversight and accuracy.

While managing clinical trials will never be as simple as ordering a product from an iPhone, there is a tremendous opportunity for life sciences companies to transform their operations and processes through a unified clinical environment.

Read the full global report to gain insight and analysis on the needs, barriers, and opportunities for unifying the clinical trial process.

Josh Hopkins, Marketing Manager Analytics & Digital Marketing at Roche Diagnostics

Both pharma and medical devices and diagnostics companies share similar marketing hurdles, and pressure around regulatory challenges. Though these two segments of the life sciences industry differ in many ways, at the end of the day, everyone is dedicated to putting the patient first.

What are the content management and distribution challenges we face in our industry? Firstly, keeping up with our growth. A growing number of products means the complexity of your business may require additional content for each piece of the business. Managing and distributing all of this content, while remaining compliant, can be difficult. But, shouldn’t the solution be simple?

Where Do We Start?

First, it’s essential to create a project team who is responsible for the ongoing success of your organization’s content. Next, identify procedural gaps. Map out and define who is responsible for posting, removing, and updating content. Finally, standardize your procedure with a quality process and set clear accountability for how content is distributed and managed outside of your content management system.

The Three R’s of Content

The three R’s of content are key principles and ways that you can eliminate content waste and protect your marketing investment.

Reduce
One of the first steps in looking at ways you can maximize content is to remove the clutter. If you can’t identify the purpose of a piece of content, stop investing in it. Be sure to have proper metrics in place so that you can analyze your content’s performance to determine what moves the proverbial content needle and what doesn’t.

Reuse
Reusing content does not simply mean republishing verbatim. One of the most critical concepts of maximizing the return and life span of your content is identifying opportunities to update, enhance, or repackage existing content. According to Jay Baer, a leading marketing expert, there are four primary content marketing metrics you should be paying attention to: consumption, sharing, lead gen, and sales.

Recycle
Think of recycling as a way to creatively repackage an existing piece of content at the end of its lifecycle. Make sure you’re repurposing high-priority assets into multiple formats to expand marketing opportunities. You can break down large content into smaller pieces, or combine small pieces of content into something bigger.

Keep in mind that recycling content is more than just creating a new format. When strategically planned and mapped across the customer journey, be sure you are creating the right amount of content for each stage of the funnel.

Tying it All Together

When working to deliver tailored content faster, be sure you perform content audits on a regular basis to identify where potential gaps exist. If you aren’t actively checking for version changes and control, then you’ll most likely still have outdated, promoted content that isn’t in compliance with your MLR process. Create compliance procedures and processes by establishing a team, clear accountability, and set defined procedures.

Finally, remember the 3 R’s of content – reduce, reuse, and recycle your content.
Repackaging, repurposing, and recycling content is one of the only ways to make content marketing scalable at no extra cost. These compliance standards and processes can help your organization deliver content faster in a more compliant way.

Territory alignment and targeting are crucial business processes for life sciences commercial teams. They are the bridge between a company’s go-to-market strategy and its execution in the field. However, the traditional way of managing territory alignments is complex, burdensome, and highly inefficient. As a result, alignments are often unable to keep pace in the highly dynamic commercial environment. Companies typically rely on spreadsheets, multiple systems, or third-party vendors. The resulting administrative burden drives up costs without necessarily leading to better customer engagement.  

Our vision is that territory alignment and targeting are managed in a single, integrated solution by empowered commercial teams with full visibility and control of go-to-market planning. And with our latest release of Veeva Align, our customers will now be able to conduct target planning alongside territory alignment, directly in Veeva Align, providing the ability to:

Align reuses common channel criteria across field teams to significantly reduce transition time between cycles. In addition, its targeting rules engine finds targets automatically so they no longer have to be manually identified.

Of course, this is all in addition to current Veeva Align capabilities. The ability to manage territory structures and assignments, determine target customers, and generate and execute multichannel cycle plans in a single, integrated solution is novel in the life sciences industry, and will greatly streamline the go-to-market process for Veeva Align customers.

By tightly integrating territory alignments with CRM, commercial teams can reduce the administrative burden of alignments, eliminate the need to rely on third-party vendors, and deliver better multichannel resource allocation.

We’ll be discussing this, plus lots more, in our next Veeva Align webinar. Please register now to see all of our latest innovations.

At Veeva, the most important thing is our relationship with our customers. We aim to help companies and the individuals working on Veeva projects to be successful. Many customers are pushing the boundaries and driving transformation in the industry, presenting an opportunity to collect and share their insights to help evolve your company’s commercial operations.

In our new “Digital Accelerator” series, hear from trailblazers that are implementing digital innovations to transform their organization. You can learn about emerging trends and discover actionable best practices from commercial leaders to accelerate your own digital transformation journey.

In the first installment of the series, host Lisa Henderson, editor-in-chief of Pharmaceutical Executive, talks with digital pioneers at Biogen, GSK, Medac, and Nestle Health Science about their digital transformation journey and strategies to help you achieve your business goals. She also interviews industry leaders Alex Azar, former president, Lilly USA & former Deputy Secretary, U.S. Department of Health, Veeva CEO Peter Gassner, and Veeva President Matt Wallach to gain their perspective on major trends that are impacting the life sciences industry.

Here are the first six episodes:

Fireside Chat with Alex Azar and Matt Wallach
Alex Azar, former president, Lilly USA & former Deputy Secretary, U.S. Department of Health sits down with Matt Wallach to discuss the major trends impacting the life sciences industry.  Listen to these industry leaders talk about why the death of the pharma sales rep is greatly exaggerated, the pivot to key account management, and the impact of digital disruption.

Strategies to Drive Digital Transformation  
Pioneers from leading biopharma companies share insights about their digital transformation journey. Learn best practices to integrate digital into the business for more efficient customer engagement across multiple channels.

Executive Spotlight: A Conversation with Alex Azar  
Alex Azar, former president, Lilly USA and former Deputy Secretary, U.S. Department of Health shares insights about the impact of specialty medicine, tactics to succeed at key account management, and the importance of modernizing content management capabilities.

The Evolution of Intelligent Engagement
The next phase in commercial operations is intelligent engagement, where teams can better use data to make smarter decisions to better engage with customers. Industry experts reveal their strategies to make engagement more tailored and seamless.

Executive Spotlight: A Conversation with Peter Gassner
Veeva CEO Peter Gassner talks about digital transformation in the life sciences industry and the importance of industry collaboration. See what’s next in life sciences.

The Changing Role of the Sales Rep
Life sciences professionals share their perspective on the evolving role of the sales rep. Hear how these leaders are enabling sales teams to drive smarter, informed interactions with customers.

These six episodes are just the beginning of the series. Future episodes will cover the impact of specialty medicine, the importance of industry collaboration, shift to patient outcomes, and much more. Stay tuned and subscribe to the Digital Accelerator page. Please share your feedback about the series and let us know what other topics you would like to see covered.  

Ms. Vernazza contributed to this article in her personal capacity. The views expressed are her own and do not necessarily reflect the views of Sanofi or Sanofi Genzyme.

Life sciences leaders are scaling medical teams to match the role’s expanded remit – a move that means increasing not only their size, but also their strategic scope. While our industry is making strides in expanding the number of medical science liaisons on the job, more work is needed on the second half of the equation: transforming the role itself and empowering MSLs to thrive in it.

Today’s healthcare landscape is incredibly networked, and HCPs face an acute need for timely answers to more complex scientific questions. Layer on the demands of transitioning to digital, and it is clear that field medical requires a shift in approach. Medical field-based teams should consider new processes enabling MSLs to reach the right stakeholders, quickly tailor engagement, and capture insights for more data-driven strategies. Fueled by a multichannel CRM systems designed for medical affairs, this represents a new way of approaching scientific engagement.

In my last post, I discussed key capabilities the modern MSL needs. But what steps can companies take to move forward, and what does the journey look like?

As medical teams evolve, they’ve uncovered best practices along the way that have smoothed the path toward thinking and working differently:

Creating a Culture of Change

Successful, strategic organizational change requires a high level of communication (early and often) to all relevant teams. Months before a roll out, start communicating about the change in order to foster high adoption when the system is deployed. Also, recruitment of a strong network of internal change champions is key. Digital-savvy end users not only help design the requirements and customize the build out, but also act as ambassadors for the impending change. They will talk with colleagues about the timeline, the benefits of the change, and what to expect. This way, all stakeholders know exactly who contact with questions and where to get updates.

Data-driven Planning and Engagement

Another success factor in implementing a new CRM is taking full advantage of medical data. With so much valuable information collected, how will it be used effectively to shape medical strategies? Using and analyzing data on customer interests and channel preferences, as well as leveraging reports and dashboards to evaluate performance of teams, is crucial. Taking hundreds of clinical insights collected in a CRM and performing data mining or text analytics to pull out scientific trends is extremely valuable. When MSLs start seeing this data, and uncovering insights that are immediately actionable, they get excited about building stronger relationships – in turn speeding adoption.

Leveraging the data in medical CRM, medical affairs teams can get a full picture of KOLs’ scientific interests in order to improve KOL engagement.

Key activity metrics can be viewed to determine resource capacity planning exercises and how to best grow field-based teams. For instance, if data shows MSLs are spending most of their time on internal activities, it signals a fundamental is needed with either team sizing or prioritization. At the end of the day, the value of technology is its ability to contribute meaningfully to business decisions.

The Right Foundation

Another key success factor is the ability to maximize technology to achieve medical goals without being burdensome for MSLs. Tool and systems should be as easy as possible for field teams, meaning the system has to work seamlessly from a technical perspective, with short data sync times, and proper alignment of stakeholders into their universe. Because MSLs spend so much time traveling in the field, the system needs to be intuitive – these teams don’t have time to waste figuring out software between meetings with stakeholders.

Beyond usability, it should be easy for MSLs to visualize the healthcare landscape as well as gain deep insight into each stakeholder, directly in their workflow. This level of visibility allows for faster and more strategic pre-call planning, as well as mapping strategies to account-specific objectives. Finally, tools should be easy for MSLs to capture information from interactions, across all channels, and refine engagement based on insights and analytics.

It’s an exciting time to be in medical affairs. Science is advancing every day, and field-based medical teams have the opportunity to make an impact in delivering better healthcare and improving patients’ lives. Realizing this vision means taking a look at how we approach our partnership with healthcare, adapting and growing with the evolution of our industry.

Monica Kennedy, Director, Regulatory Operations at Halozyme

Halozyme is growing and our methods for managing regulatory information weren’t scaling with the rest of our business. Regulatory needed an efficient way to capture an accurate record of our products, activities, and partnerships. That simple business need triggered a substantial overhaul of our information management processes. Now, we can easily answer questions about our business, whether looking for outstanding commitments, locating FDA concerns on a specific submission, or providing a list of all adverse events submitted to a study during a specified period.

Before Vault RIM, we used 35 Excel workbooks to track submissions and correspondence by product. The workbooks contained separate tabs by country where relevant. While there were many spreadsheets, each one only tracked eight fields. Our tracking was limited to critical items, such as date, sequence number, description, and content hyperlinks. In some cases, related information was captured elsewhere in a separate spreadsheet. In most cases, non-critical items didn’t offer sufficient value when maintained in a spreadsheet, therefore they weren’t captured.

We now use Vault RIM and have comprehensive visibility across regulatory activities and information. We track 17 different dimensions of our business, including drug products, active substances, submissions, promotional pieces, registrations, and more. Each dimension (or tracking object) has its own set of unique tracking fields and relationships. For example, our submission tracking object has 15 descriptive fields and eight relationships. The relationships connect submissions to things like clinical studies, drug product, and related correspondence. From the correspondence, we can now navigate to related applications, submissions, health authority questions, commitments and back to the correspondence.

There are immediate benefits, such as it being substantially easier to find a piece of information in question, and it being substantially easier to generate status reports and performance metrics. Yet the biggest benefit is the ability to answer questions about the business. Put simply, the visibility enables me to be more efficient, effective, and credible as I can substantiate my requests and claims with data. When I need to highlight an increase in workload to justify additional headcount, craft a performance review, or submit a promotion for someone on my team, I can run a report that showed how many submissions were produced during a given period and how the volume of submissions has increased as compared to another period. That would have taken hours to produce before we had Vault RIM.

As we embarked on this RIM transformation, the biggest question from my team was “How are we going to possibly collect all this additional information?” I’ll answer that question in detail during my presentation at the Veeva 2017 R&D Summit. But in a nutshell, the information is collected progressively as it is needed and only if relevant. We’ve designed new business processes for things like managing correspondence and questions from health authorities. We’ve also centralized data collection – Regulatory Operations and Regulatory Affairs used to maintain separate spreadsheets, each for their own responsibilities. Now, Regulatory Operations is the custodian of all regulatory Information and Vault RIM is where it is housed and consumed.

If you’d like to hear more about our journey or ask questions in person, I’ll be presenting at the Veeva 2017 R&D Summit, on October 3. You can register here.

Patterson Shafer, Life Sciences Specialist Leader, Deloitte Consulting LLP

Regulatory Affairs teams can be instrumental in speeding time to market through innovative registration strategies as well as effective submissions development. Regulatory also plays a key role in maintaining patient access to products and optimizing profitability through effective lifecycle management. The business case for leading-class regulatory capabilities should therefore be focused on maximizing revenue and minimizing compliance and quality costs, rather than simply focusing on process efficiency.

Value reflects the balance between costs and benefits. Investment in an effective RIM solution involves not only the RIM technology, but process, organizational change, and data management elements. However, investing in the regulatory function, if made appropriately, could return substantial benefits in cost avoidance and improved financial performance.

Previous challenges defining the business case for RIM are due in part to how the scope of change radically effects the financial impact. Any single RIM capability will likely have a proportionally smaller impact if changed independently rather than as part of a broader initiative. Due to the complexity of regulatory processes, particularly in multi-national companies, taking a unified approach will likely deliver returns far greater than the sum of smaller, isolated initiatives. Below are a few of the potential benefits from a unified approach to RIM:

When making the business case for RIM transformation, companies should plan, and budget for, non-technology activities such as process re-engineering and data governance initiatives. It has been said that “culture trumps strategy;” as such, changing attitudes and behaviors is no simple effort. Organizational Change Management should be integrated in all design, piloting, and implementation efforts. Investing in communications, training, and ongoing support can help ensure successful adoption and sustainment of the changes associated with implementing RIM.

We will be at the 2017 Veeva R&D Summit this year sharing our latest whitepaper on the value of a holistic RIM capability. Please stop by to pick up a copy or discuss your own RIM transformation goals. If you haven’t registered yet, you can do so here.

The agenda for Veeva Global R&D Summit is now live!

The life sciences industry continues to evolve and change. As a result, more and more organizations are looking at their business processes and supporting technology landscape to gain efficiencies, increase collaboration, enhance compliance, and ultimately, bring products to market faster. Across the board we are seeing an unprecedented and industrywide shift towards unified systems and processes that are connected across the enterprise. This year’s Veeva R&D Summit will explore what the move towards unified and connected systems and processes means for the individual, the functional areas, and the enterprise.

The Summit’s clinical track will highlight lessons learned and best practices for moving to a modern, unified clinical operating model. Hear from Ora, Inc. on how leveraging the Vault Clinical Suite is not only modernizing and unifying their clinical systems, but also supporting an integrated set of business processes across many global studies. Eli Lilly will discuss how a holistic strategy for deploying connected eClinical systems can drive clinical development activities and build collaboration across team members. Also, hear directly from customers C.R. Bard and Daiichi Sankyo on how to achieve a constant state of inspection-readiness by transitioning from a passive to an active TMF model. And don’t miss our session on next-generation EDC.

Over on our quality track, discover how unifying quality document and data management provides greater operational visibility into quality processes across the enterprise. Learn how UCB closed the gap between their internal functions and external partners by leveraging a single quality application to increase business alignment and collaboration. Additionally, see how REGENXBIO leveraged quality metrics and unified dashboards to monitor and accelerate processes and improve overall operations.

In regulatory, the buzz is all about RIM transformation. BMS kicks things off by reviewing their plan to achieve a global, unified RIM environment, starting with submission tracking and content planning. Halozyme will share their journey to increased visibility and traceability across submissions, regulatory activities, and registrations with Vault RIM.

Achieving a unified application environment would not be possible without a strong Vault foundation. Join the Vault Foundations track to discover how the Vault platform unifies content and data, enabling organizations to quickly deploy powerful solutions to specific business challenges. Attendees in this track will also learn about tips and tricks for global deployments, managing Vault in a multi-application environment, and technical configuration of broad capabilities, such as Vault security.

Finally, join us on the second day for more than 15 Vault roadmap sessions, covering everything from Vault applications to Vault Platform. These in-depth sessions with our product management leaders will give you an exclusive look at the latest innovations and capabilities coming your way.

View the full agenda here and register now!

Jen Goldsmith is SVP, Vault at Veeva Systems

From conferences to symposiums and user groups, there are no shortage of industry events focused on digital asset management. The trouble with these events is that they are often focused on non-regulated industries so the learnings are not transferable to the challenges facing life sciences professionals.

Until now….

On October 26, 2017 eighty life sciences professionals will converge on Philadelphia for the Digital Asset Management for Life Sciences Forum – the first, and only industry event dedicated to digital asset management for life sciences organizations.

Here are the top three reasons to attend:

1.The Lineup
We’ve compiled an experienced panel of speakers from Bayer, Merck, GSK, and Pfizer, as well as leading DAM experts who have first-hand experience with DAM for life sciences organizations. They’ll cover everything from creating a content marketing factory and using DAM to manage modular content, to usage rights, and how to successfully implement a DAM.

2.The Learning
As the volume of digital content continues to rise, managing assets while maintaining compliance with industry regulations remains a top priority for organizations. We’ll discuss trends in content marketing for life sciences, review case studies, and examine the latest thinking and direction for DAM. Whether you have implemented a DAM, are just starting to explore the benefits of a DAM, or are looking for best practices, you will take away valuable insights.

3.The Networking
Since this is the only event dedicated to DAM for life sciences, you will be in a forum of peers where you will have the opportunity to meet individuals who understands the nuances and unique challenges of marketing, content management, and digital asset management in a complex regulatory environment. We’ll provide an intimate and unique environment to share experiences and build long-lasting connections.

Learn more about the Digital Asset Management for Life Sciences forum here.

For small-to-medium life sciences companies, events are often the primary means for engaging face-to-face with key thought leaders. But as a pharmaceutical marketer in a growing company, taking advantage of those critical opportunities was an uphill battle. A convoluted events management process managed in a multi-page Excel spreadsheet, unclear communication, and transparency challenges meant delays. As a result, our team was scrambling to meet deadlines and incurring greater costs – including increased fees for late registrations, which ate into our budgets. It’s a common pitfall for marketers: less time to prepare for events, and more process inefficiencies.

We needed to evolve our events program to become a true driver of our business. And to enable this change, we required a simple way to manage some of our core processes:

By eliminating manual event management processes and centralizing all activity on a single solution designed for life sciences, we gained visibility and control. Within two months, we went from tracking 3 to a core set of 10 event types, and we can easily report and see results against them.

Today, we’re able to collaborate more effectively with our logistics providers, develop event-related content more quickly, and gain efficiencies across the event management process. As a result of this increased transparency, we were able to reduce our marketing spend by 15%. And critically, we are seeing a six-month event lead-time that enables us to plan our program strategy more strategically. And those results have been truly significant to our overall marketing strategy.

From beginning to end, all event information is captured in our CRM system and combined with customer profiles, giving us visibility into the impact of our messaging, as well as aggregate spend. For our reps, gaining immediate insight into event details in their workflow helps them maximize the opportunity to meet face-to-face with core stakeholders.

Across the myriad of moving pieces that comprise a scientific events program, the key to success is maintaining alignment – not only across teams and partners, but also with customers. Looking to the future, we’re excited by the potential of events to serve as a driver of customer experience, as we continue to track HCP event data over time. To learn more about our journey, please take a look at how we designed our new event management process, and our key takeaways from implementing a new approach at a growing organization.

More than 250 global, clinical operations professionals came together at the fourth Veeva R&D Summit this month in Philadelphia. Two key themes dominated discussions; unified clinical and the move from passive to active TMF.

Janssen’s Terry Murphy kicked-off the clinical sessions by detailing his company’s approach to unifying clinical operations on a single platform. Coming from a manufacturing world before joining Janssen, Terry was “stunned by the amount of paperwork still moving around.” He talked about the benefits of implementing a wholesale change, including leveraging real-time data for better patient engagement, proactive trial adjustment, and ultimately, delivering cures faster.

In a separate session, Ed Leftin discussed Ora, Inc’s journey to modernize and unify their clinical technology landscape. He described some of the challenges that drove them to find a better way to manage clinical trials – such as spreadsheets to track spreadsheets. The audience nodded in agreement at a slide depicting how clinical operating environments typically look prior to unifying clinical systems.

A typical clinical operating environment before unifying, according to Ed Leftin

He described Ora’s approach of bringing together CTMS, eTMF, and study start-up on one system with Veeva Vault Clinical Suite and shared tips on successfully transitioning to a unified clinical operating environment. Improved collaboration and real-time reporting and visibility were just some of the benefits cited.

The move from passive to active TMF management was high on the agenda for another year at Summit. In a passive TMF operating model, documents are only uploaded to the system when they are finalized. Conversely, active TMF management ensures all TMF information and processes are managed in the same system, in real-time, as they are being executed.

C.R. Bard, Inc and Daiichi Sankyo, Inc explored the advantages of transitioning from legacy systems to active TMF. Daiichi Sankyo, Inc’s Jamie Toth talked through their journey to streamline manual processes globally and the benefits achieved, such as improved quality control. C.R. Bard, Inc’s Rushil Sankpal shared his company’s dramatic increase in TMF maturity level – particularly with collaborative content creation and compliance and governance – since moving to Vault eTMF.

Janssen’s Shayna Lambert suggested making inspection readiness part of a daily, active TMF routine. She led the audience step-by-step through preparation for a recent, successful inspection and offered a sneak peek at her inspection-ready checklist. She also reinforced how planning is vital for smooth-running inspections.

This year’s Summit was a great platform for peer learning and advice-sharing. It was exciting and informative to be part of those conversations. We’re looking forward to watching the industry’s progress over the next 12 months. Until next year…

To find out how unifying clinical operations can enhance your clinical trials, check out our unified clinical demo here.

Click here to catch up on this year’s Summit presentations

The Veeva Creator Series is a regularly published series of interviews with Veeva product leaders and strategists highlighting the backstories to key CRM innovations. This month, we interview Mark Johnson, VP of Product Management, about the coming Veeva CRM Sunrise UI.

What is the Sunrise UI?
Sunrise is a refresh of our Veeva CRM user interface. It strikes a balance between familiarity and innovation. Users will be able take better advantage of a fresh UI without having to relearn everything. Sunrise is also fully adaptive to different types of devices – field teams will be able to use CRM on their computers, tablets, and phones. This type of complete mobility will be a first in the life sciences industry.

What compelled you to update the UI?
Customers are used to a consumer experience in which they get regular software updates for their apps. At Veeva, we believe business apps can be as modern and intuitive as the consumer apps they use every day.

That is why we consistently strive to provide a modern CRM experience. The new UI is part of our ongoing commitment and investment in Veeva CRM. And because Sunrise is designed to be intuitive, users will also be able to more quickly find the information they need to get their jobs done.

Can you provide some specific examples?
There are lots of updates throughout the app but our design is heavily focused on providing a user-friendly CRM. For example, we’re moving the navigation bar from the side to the bottom, allowing us to use more of the screen real estate to improve information density and clarity. We’re also placing an emphasis on discoverability of information, to intuitively help guide users on what to do next in the application. The functionality and flows of Veeva CRM, however, will remain the same as they are today.

What is the biggest challenge in developing Sunrise?
The Veeva CRM user base is large and highly diverse. There are enterprise-scale companies all the way down to specialty start-ups who are launching their first product. Furthermore, the app itself is highly configurable. So, in essence, there are many different user experiences out there today. We took extra care to make sure that we strike the right balance of familiarity and improvement. It is an important aspect of the release for us.

How should customers prepare for the upgrade?
From a user perspective, we purposefully designed Sunrise so that if someone is already familiar with Veeva CRM today, they will be able to start using Sunrise right away.

On the back end, there are no setting or layout changes to worry about and admins won’t have to do any object configuration changes either. It is as simple and straightforward as any of our regular product releases.

What is the big takeaway about Sunrise?
We are confident that Sunrise will strike the right balance between familiarity and innovation. Our goal is that the field force feels like it has made their jobs easier. Similarly, we don’t want admins to be concerned about a massive, complex, and IT-intensive upgrade. With Sunrise, we have worked hard to make sure that the burden of upgrading is not on our customers, whether end users or home office IT.

Where can customers get more information about the upgrade?
Our FAQ answers many common questions and there are links to more in-depth training videos as well.

About Mark
Mark Johnson is responsible for the Veeva CRM roadmap, product innovation and customer success. He has been with Veeva for three years and comes from a background of both product management and software engineering. His favorite thing about Veeva is the speed of solution delivery: “Our product roadmap is always ambitious. I love to watch the team execute on it, to make those innovations real for our customers. It’s a constant source of pride for us.”

This year’s Veeva Summit was a culmination of many key milestones for quality. The Veeva Vault Quality community, comprised of quality professionals from life sciences companies, previewed its first position paper, “Risk-based Approach to Change Management of Validated GxP Systems.” A working group of six community members, led by Sean Smith from Blueprint Medicines, proposes a risk-based approach to streamlining GxP system configuration changes and release updates – without compromising the quality of the “system product” or the integrity of the validated state. While the scope of the paper focuses on Veeva Vault QualityDocs, the principles and methodology can be applied to a wide range of GxP systems and aligns with ICH Q7, ICH Q9, ICH Q10, and GAMP 5. Numerous companies are investigating, or in the process of implementing, risk-based processes and were thrilled to get a first look at the position paper. It will be widely available in mid-November – please register here for a copy.

Applications that do not work well together and fragmented processes have always plagued quality organizations. Ionis’ presentation discusses how it was difficult for users to traverse between separate QMS and content management solutions. Creating new processes in the legacy QMS system was also challenging. Moving to a unified quality suite that is easy to use and administer provides a superior user experience and enables Ionis to keep up with new business requirements. Veeva Vault QMS was launched just over a year ago and companies are seeing the benefits of it working seamlessly with Veeva Vault QualityDocs – driving rapid growth in the Veeva Vault Quality Suite. Ionis joins more than 30 of the 120 Vault Quality Suite customers that own Vault QMS – with many of them deploying or having deployed Vault QualityDocs.

Keeping employees trained so they can perform their jobs at the highest level of proficiency is also crucial to quality. UL presented a case study on Insmed. By leveraging the UL connector to integrate ComplianceWire, a LMS solution, with Vault QualityDocs, Insmed improved inspection readiness, learner retention, and employee performance.

As companies outsource critical functions, they need to work closely with partners to maintain quality oversight. Companies, such as Gilead and Karyopharm, are directly incorporating partners into quality workflows – improving data integrity, accelerating cycles times for processes including lot disposition, and keeping vendors informed on current policies and procedures. There are now over 100 contract manufacturers, test labs, and other partners that leverage Vault QualityDocs to send data and documents, or stay up-to-date on contractor manual changes. A chronological audit trail of who sent, reviewed, or accepted the data or content is captured for audits and inspections. The information can also be leveraged to track partner performance and help both parties achieve common goals. With Vault QMS, pharma companies will be expanding access to partners and allowing them to directly respond to audits, or enter deviations and corrective and preventive actions (CAPAs) – gaining real-time visibility.

Processes such as change control require orchestration of event or time-driven tasks across many different parties. Multiple customer presentations, including “The Future of Quality Management” customer panel, echoed that there are significant opportunities for streamlining cross-functional processes. The Veeva Vault Development Cloud provides a technology foundation for drug development, and is gaining momentum. For example, with the Vault Quality and Vault RIM suites, companies can manage the change management process from the beginning where regulatory insight is needed by the quality team for decision-making, to downstream document and regulatory changes, and finally determining shipping decisions based on regulatory approvals – all on a single platform. Hopefully, next year we will see presentations on how customers are leveraging the Vault Development Cloud to drive more efficient end-to-end processes. Mark your calendars for September 18-20, 2018 at the Philadelphia Convention Center. Hope to see you there!

Earlier this year, EMA announced delays in the implementation and enforcement of the of IDMP standards to beyond 2020, due in part to Brexit and the EMA headquarter relocation. EMA also delayed progress on the controlled vocabularies program for Referential Management Services (RMS) and Organizational Management Resources (OMS).

Following this announcement, IRISS surveyed the industry to gauge the impact of further delays. Some interesting observations emerged:

• Most respondents are optimistic that the IDMP and Substances, Products, Organisations and Referentials (SPOR) initiatives still hold business value. Additionally, most companies (59%) with an IDMP/SPOR program are proceeding, despite the deadline delay and lack of clear guidelines from EMA. However, about one-third of respondents put their program on hold, awaiting the publication of the EU implementation guidelines and an EMA revised plan. Less than 10% of respondents have closed or reduced the scope of their projects.
• The delayed EMA guidance is having a greater impact on plans for internal process changes to support SPOR and IDMP compliance. A minority will proceed as planned, while 24% will put process changes on hold. Many of those indicating there will be “some impact” will narrow their focus to those process improvements with internal business value, whereby IDMP compliance becomes a side benefit.
• How to access and consume the EMA master data management services is a key area of focus for respondents. Access through the web UI is preferred over using the API (application programming interface). Plans for consuming the Organizations and Referentials data varies broadly, as about 30% of respondents will align these terms with all internal systems. Another one-third will align the terms with only regulatory systems. The remaining respondents will align the data fields on a case-by-case basis.
• The technical approach to managing IDMP data varies: 43% of the respondents plan to use a separate IDMP hub with data feeds to and from other systems, 20% will manage IDMP data within their RIM system, and 26% have yet to decide.
• Most RIM system initiatives will proceed despite the delays: 29% will continue even though related to IDMP/SPOR, 29% will continue decoupled from IDMP/SPOR dependencies, and 17% will continue as they had no relation to IDMP/SPOR. Similarly, most initiatives around Falsified Medicines Directive (FMD) will proceed, with 31% decoupling their FMD initiative from IDMP/SPOR dependencies.

From the IRISS survey results, it is evident that industry still supports IDMP/SPOR initiatives. However, requirements and specifications from the EMA are critical to ensuring success.

Cindy Piccirillo
Group director, global regulatory business capabilities
Bristol-Myers Squibb

“We can’t move at the pace of pharma, we need information instantly. That’s where working on one single platform is the natural solution for us.” Cindy Piccirillo took the stage at Veeva R&D Summit to describe their regulatory transformation program, an initiative to transform their business operations with a global, authoritative source of regulatory information.

BMS as a company is transforming its portfolio, shifting their focus to oncology medicines where the pace of innovation is extreme. For the regulatory team to keep up, they needed to address their disparate legacy systems. “Some technologies were quite aged and no longer of use. The primary system is seventeen years old. The team jokes that it is old enough to drive.”

Phase one of their three-part initiative addressed global submission planning and submission content plans. This was an area with no supporting systems, work was done manually on spreadsheets. This is also an area that plays a key role in getting medicines to patients quickly. When getting executive sign-off on such a major initiative, the business case needed to demonstrate that they would accelerate their submissions and could quantify the benefit of getting to patients faster.

The BMS partnership with Veeva is built around a shared desire for speed. One of the IT leaders at BMS noted the historic difficulties of working with software releases that slip past their original delivery date. Piccirillo noted how Veeva’s firm timeline with known releases makes budgeting and planning so much easier. “The company is becoming accustomed to a faster pace of change and is building a culture of speed. It has been a fantastic partnership – it’s one team, one dream.” To hear more about BMS’s RIM transformation, listen to their keynote address at Veeva’s R&D Summit or view their presentation within the regulatory track.

Veeva customers continue to push the industry forward with initiatives to streamline product development in clinical, quality, and regulatory. Recently at the Veeva Global R&D Summit, we recognized five trailblazers that are transforming product development processes.

Danielle Beaulieu, Bristol-Myers Squibb

Danielle is at the forefront of BMS’s RIM transformation program to simplify global submissions and tracking globally. She is leading the implementation of Veeva Vault Registrations and Veeva Vault Submissions Archive to unite headquarters and local affiliates on a single platform for submission planning and tracking, product registration information, regulatory correspondence, HA commitments, HA queries, and archived submissions. She has also been a resource to the industry, sharing best practices with her peers to help advance their regulatory transformation initiatives.

Patrick Fredericksen, TESARO

Patrick played an instrumental role in helping Tesaro streamline regulatory, quality, and clinical processes on one platform to drive greater business efficiency. By implementing Vault Development Cloud applications, including Vault eTMF,  Veeva Vault QMS, and Vault Submissions, Tesaro centralized content and data management across the company, delivering a unified source of truth for regulatory and clinical information to speed drug development.

Ed Leftin, Ora Inc.

Ed and the leadership team at Ora had the vision to modernize clinical operations by moving to a unified clinical model. As pioneers, they implemented Veeva Vault Clinical Suite to bring together eTMF, study start-up, and CTMS on one platform. Ed helped streamline clinical processes to speed execution, improve study quality, and gain visibility across the trial lifecycle.

Jamie Toth, Daiichi Sankyo

Jamie is committed to transforming clinical operations and how Daiichi Sankyo manages eTMF globally. Jamie led the implementation of Vault eTMF to 1,600 users across the globe, including internal teams and external partners to standardize business processes and improve collaboration. After the successful implementation, other business groups rolled out Veeva Vault QualityDocs, Vault Submissions, and Vault Submission Archive. Daiichi Sankyo is now driving greater consistency globally at every stage of product development, from clinical to quality to regulatory.

Praveen Vangeti, Gilead

Gilead modernized quality in the cloud to enable a comprehensive audit trail and improve data integrity between the company and its many partners. Praveen’s pragmatic and methodical approach contributed to the successful rollout of Vault QualityDocs across both internal and external stakeholders. Now it is easier for external partners, such as contract manufacturers and contract test labs, to submit content directly to Gilead securely and efficiently as well as participate in review and acceptance workflows with a comprehensive audit trail. Based on the success, Gilead is expanding Vault QualityDocs across the entire global enterprise to manage all standard operating procedures.

Life sciences is on the cusp of a “digital transformation economy”: by 2020, digital revenue is expected to increase by 80%, with 50% of IT budgets tied to digital transformation.¹ Chances are, if you’re in life sciences commercial operations, you have been thinking deeply about digital transformation, what it means to your customers, and how to make it a reality within your organization.

Often, digital adoption within life sciences can look uneven – different brands and teams may undertake separate initiatives, making it difficult to get a single customer view and engagement approach. But as companies mature, the next step to using digital to add value to HCPs is ensuring that engagement looks consistent – though not necessarily identical – across brands, and continually refining content based on data. And with the breadth of what digital transformation can entail, knowing where to start can be its own challenge.

Digital transformation is key to competitive advantage in life sciences, but how can companies achieve differentiated multichannel engagement strategies?

Over the past several years, as digital disruption has revolutionized life sciences, best practices and operating principles have emerged. Join Veeva for an in-depth, step-by-step look at what it takes to establish a successful multichannel strategy, featuring a case study on Sanofi’s new digital content operating model.

You will learn about:

Don’t miss this chance to learn about multichannel from the experts, and get your questions answered.

¹ https://whatsthebigdata.com/2015/12/27/gartner-idc-and-forrester-on-the-future-of-digital-transformation/