The pharmaceutical industry has a reputation for making significant investments in risk management. After all, they manage a business with a high level of risk – financial risk from very expensive research programs, reputational risk from testing new compounds on humans, and constant regulatory compliance risk. Mitigating these risks are a core determinant of success, and a quality risk management (QRM) approach that is well understood and commonly accepted is required.
I recently had the opportunity to present at the Institute of Validation Technology (IVT) Quality Risk Management conference, which brought together quality professionals from pharmaceutical companies. One of the hot topics was the industry’s true level of maturity in applying QRM principles. Recent press about poor product quality suggests pharmaceutical companies may not be far along the ‘Risk Maturity Model1‘, and there are many opportunities for improvement.
We explored recent research in QRM2, and trends in compliance enforcement actions – namely FDA warning letters:

• Drug product recalls from 2006-2013 is increasing
• Recalls related to product quality is increasing
• cGMP-related warning letters with 1 or more QRM citations is increasing
• The majority of QRM citations issued were due to a failure to apply QRM

In looking at the five phases of the Risk Maturity Model, these findings indicate that some pharmaceutical companies are between Phase 1 and Phase 2, where QRM activities are informal, inconsistent, and insufficient.

While not a reflection of QRM adoption in every company, it’s nonetheless a good call to action as quality professionals expand efforts to improve product quality.
To support continuous improvement in quality, please join a quality roundtable with thought leaders on Thursday, May 28, 2015 to discuss how organizations can move up the quality maturity curve with risk management being a key aspect. Look for additional information in the coming weeks.

1. Risk Maturity Model adapted from PDA Technical Report No. 54. PDA Technical Report No. 54. “Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.” 2012.
2. Quality Risk Management: Diagnosis or Cure?, Kelly Waldron, PhD Researcher, January 25, 2015

Customer success manager, Bob Kenney, recently caught up with Brandi, the Vault QualityDocs administrator and quality systems specialist at Forum Pharmaceuticals, on how the latest version of Vault QualityDocs has improved their organization. Here is an excerpt from their conversation.

Bob: What capability in Vault QualityDocs V10 has made the greatest impact to your company?

Brandi: Before V10, a SOP could sit around for 3 weeks or more waiting for everyone to review it, even though we knew the document had to be revised – as one person had already rejected it. Now with the short-circuit workflow, cycles times are much shorter and we don’t waste people’s time. Once someone rejects the document, the task is removed from everyone else’s queue, and the author/owner is notified of the rejection and can immediately make changes.

Bob: Were there any other capabilities that improved the timing of SOPs?

Brandi: Yes, the bulk read and understood (R&U) feature combined with binders organized by job role. For example when there was a new employee, it use to take about 40 minutes to get all the SOPs that they needed to be trained on out the door, as we had to find and click each SOP to send the R&U task. Now it takes about a minute – we click on bulk R&U for that job role binder, check desired SOPs, and Vault QualityDocs sends an R&U task for all selected content.

Bob: You said you use the delegation functionality, and I was surprised at how quickly you adopted it.

Brandi: This capability helps us keep things moving. People who are out-of-office delegate tasks to other team members, and our executives/senior managers can delegate tasks to their admin to get help managing their queue. The admin reminds them to review, and approve documents as due dates approach. The executive still ultimately owns the approval or rejection, and if the admin does approve any of the items on the executive’s behalf, it is logged in the audit trail and everyone can see who approved it.

If you have favorite features that you would like to share, please send an email to jing.to@veeva.com.

By Michael Hughes, Head of IT, Kythera Biopharmaceuticals

Disclaimer: The views and opinions expressed in this post are those of the author and do not necessarily reflect the official policy or position of KYTHERA Biopharmaceuticals, Inc.

During a career span of nearly 20 years in the life sciences IT industry, I have witnessed my share of tools and technologies come and go—from clinical development to commercial operations, our industry has adopted hundreds of solutions over the years. Almost without fail these tools and technologies have been siloed and heavily customized. After years of steadily proliferating on-premise systems—and the array of hardware and software that comes with them—we’re finally seeing technology move in the opposite direction. In today’s IT department, the next big thing isn’t the pursuit of more—it’s consolidation, harmonization, and shifting to the cloud. At Kythera, I run an IT organization that is 100% cloud-based, and the difference in efficiency is having a significant impact on our agility and the bottom line.

Standardizing on using the cloud has eliminated the time, expense, and hassle of maintaining hardware and software in-house. As Kythera makes the journey from a clinical-stage biotech to a mid-sized commercial business operation, we don’t worry about maintaining, updating, and validating dozens of systems. It may be hard to imagine, but we don’t even have a data center facility. The only hardware we maintain are employee laptops and iPads and network equipment. When it comes to securing our data, we focus on internal policies and rigorous audits of our cloud providers, which eliminates the need of an onsite security team. The vendors we’ve chosen can implement security and disaster recovery measures that far exceed what most companies can provide with their own resources

With the thousands of hours IT is reclaiming, we’re adding higher-level value. For instance, we were heavily involved in the optimization of our document management solutions. We worked with our internal business groups to design a more efficient way to get documents reviewed and approved throughout the organization. Kythera is filled with industry veterans accustomed to the struggle of legacy systems, and we’re able to deliver solutions that work. We are more agile now, so can respond quickly to changing business needs and ultimately deliver results in a timely manner.

In line with our “cloud-first” strategy, we standardized on Veeva’s solutions across our commercialization process. Veeva Vault helps us manage our content from study to launch; Veeva CRM enables more effective selling and marketing; and Veeva Network Customer Master delivers key reference data, software, and services.

In most companies, business groups don’t always expect IT to serve as a strategic partner. Our experience with Veeva and other cloud providers has been positive enough that it’s actually changing their perception of IT. We are included in strategic planning off-sites, which acknowledges the crucial role IT is playing within the organization.

When people ask me about being one of the first Veeva Vault customers, I tell them innovation is the lifeblood of biotech and that it permeates everything we do. As a company dedicated to continuous innovation, we wanted to live it and innovate across the board.

Agility can mean a lot of things. It’s grace and strength on a basketball court and it’s highly functioning teams working in unison to accomplish things that they couldn’t do alone. But, what does agility mean in the promotional content management space? What exactly does it take to be agile in managing promotion? Getting materials to market quickly and effectively is key.

Companies who demonstrate agility in managing promotional content have:

• Well organized teams
• Highly structured, yet flexible processes
• Highly collaborative environments
• Content control from creation through distribution

And, most importantly, effective companies are compliant at every stage of promotion.
Agency partners play a key role in helping life sciences companies remain agile. They must react quickly in preparing content, yet follow strict guidelines to obtain approvals and ensure that only current content is in the public domain.

From content creation through expiration, agencies are often responsible for uploading and shepherding materials through online promotional review systems. Vault PromoMats offers life sciences companies and their agency partners an advantage in achieving agility – and fast reference linking is just one way to accomplish this:

“You can upload references as a specific type of content, so that we know that they’re not for review, and that they’re easily linked, and you can annotate your pieces by linking to those references. It’s very easy and it’s very time efficient. It all leads to creating the ability for us to get things done faster in smaller budgets. So it’s hugely helpful.” – V.A. Lopes, Giant

In addition to systems that control document preparation and review, a central content repository ensures all team members receive the latest approved material. On the distribution end of the process, integration with CLM, Approved Email and other applications speeds distribution and tracks content usage in the market. Feedback on content use is just one way that life sciences companies can know what is and isn’t playing in Peoria.

Whether you are managing 100 pieces of content a year or thousands, today’s competitive space requires speed to market while meeting strict regulatory and legal requirements. Now, more than ever, it’s important to utilize the most sophisticated, yet easy to use tools, to gain cross-functional team alignment that will accelerate agility in promotional content development and use.

Brian Harper is director of Vault PromoMats strategy

Is Quality Ready to Embrace Cloud?

Over 800 quality professionals attended the Society of Quality Assurance (SQA) 2015 annual meeting. There was a lot of interest in cloud/SaaS with several presentations focused on the topic. Veeva, in partnership with Quintiles and an emerging biotech, had the unique opportunity to host a series of sessions on cloud computing exploring regulatory, validation, and implementation implications. You can view the presentation here. Highlights included:

Quintiles Advisory Services, John Rogers, lead a discussion on regulatory requirements for compliant and validated applications and considerations for cloud:

Next, Veeva examined best practices for validating cloud applications, specifically looking at:

Finally QA Manager at Medicines360, Kevin Loftus, provided a customer perspective on the implementation and validation of a cloud application – Vault QualityDocs. Working with vendors that build applications specifically for life sciences, drastically shortens project timelines. Kevin also reviewed:

View the SQA 2015 presentation here.

By Daniel R. Matlis, President, Axendia Inc. Advisor, FDA Executive Forum.

Can you distribute poor quality products while complying with regulatory requirements? Sure, after all, you can conduct a recall of poor quality products while in compliance with all applicable regulations.

Regulatory compliance and quality are not the same. In fact, industry’s hyper-focus on compliance is often an obstacle to quality. The matter of product quality vs. compliance has recently been given a push toward the quality side through a number of agency initiatives. FDA Commissioner Margaret Hamburg, M.D. states “In recent years the FDA has identified significant lapses in quality by some companies operating in the U.S. and around the world…maintaining high quality standards is a part of the cost of doing business.”

As a result of these serious quality events, “we at the FDA will continue to increase our focus on quality. One way we are doing this is through the creation of a new Office of Pharmaceutical Quality (OPQ) that will create one voice for drug quality at the FDA, and improve our oversight of quality throughout the lifecycle of a pharmaceutical product… All companies must understand that quality is the basis for the public’s trust and confidence in their products and maintaining high quality standards is part of the cost of doing business.”

FDA is shifting its primary focus from regulatory compliance to driving the industry beyond compliance to quality – with the formation of the OPQ as the first step. Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy at FDA, was instrumental in establishing the FDA’s OPQ and explains why the change in stance was necessary; “We don’t have the capacity to be in every firm all the time. We want to encourage firms to prioritize quality – and encourage their boardrooms and their pocketbooks – because quality costs money.”

With the renewed focus from regulators on improving quality, the question life sciences executives should ponder is: how can we improve quality and ensure that our company does NOT have to execute regulatory compliant field actions?

The answer is to evolve from reactive to proactive and predictive quality measures, pushing organizations up the quality maturity curve. Driving life sciences organizations to prevent issues before they happen avoids corrective costs that are often magnified post facto. In addition, as the FDA develops their industry wide risk model, developing a lower risk profile will reduce the chances of an inspection, and compliance or enforcement actions following an inspection.

Figure 1 – FDA Grading Industry on a Curve

To learn how the FDA is “encouraging” the industry to move up the quality maturity curve and hear expert advice to support your journey, join me and other life sciences industry leaders for a Quality Roundtable. Register here.

The 7th annual Veeva Commercial Summit is just weeks away, June 9-11 in Philadelphia. This annual gathering of life sciences commercial and medical leaders is one of the largest in North America. We are very excited to bring together nearly 1,000 attendees from over 100 top pharmas and emerging biotechs to learn, share, and connect.

This year’s program will be our best yet with eight distinct tracks, offering 50 sessions focused on industry trends, best practices, customer case studies, product-specific workshops, and discussion groups. And new this year are targeted Medical, Brand, and Data Summits that will offer a deep dive into these important areas of interest, and a full second day of in-depth workshops.

A great speaker lineup of industry experts and business leaders from some of the world’s largest pharmaceutical companies and emerging biotechs will offer customer success stories, best practices, and ways to get the most out of your investment with Veeva. Hear from more 30 customer speakers representing 17 innovative life sciences companies like Celgene, Boehringer Ingelheim, Kythera, and Medac.

Summit is not just about learning—you will also have a time to unwind and connect with fellow attendees. Tuesday evening’s welcome reception will give you a chance to network with colleagues and plan your next two days at Summit as well as reunite with friends you may have met at a previous Summit. Also, one highlight of this year’s Summit will be our Wednesday evening gala at the fabulous Penn Museum, one of the world’s finest archaeological and anthropological museums.

Summit is only four weeks away! Visit the Summit website to view the agenda and register now to secure your spot.

The days of one-to-one customer engagement are long gone. Now multiple individuals from life sciences commercial teams interact with the same customers, often using different communication channels. This leads to increased complexity in tracking and managing the quantity and level of interactions.

Events are an important channel of engagement that can often be overlooked. But, even within life sciences organizations the term “event” means different things depending on your role. On the commercial side, there are speaker programs, consulting, training, symposia and more. On the medical side, events range from investigator meetings to advisory boards and committees.

Each event type has a different purpose and a separate budget. But there is frequent event crossover for participants, creating compelling reasons for a complete view of all events across your enterprise. Here are a few:

The most serious consequence of an incomplete view of your customer across events is the threat of non-compliance with regulatory requirements. Risks such as non-adherence to a Corporate Integrity Agreement, exceeding expert’s internal spending cap and inaccurate transparency reporting cannot be taken lightly.

Some pharmaceutical companies customize and cobble together a variety of internal systems in an attempt to match the workflow of each unique event type. Others leverage their logistics partners’ proprietary software, but they weren’t originally designed with customer data management in mind. While this might works to some degree for an event type or two, these methods are very time–consuming, expensive and results in multiple applications with limited utility that don’t share data with each other.

The answer is a single system for all event types that delivers better visibility with greater compliance—and is built with commercial life sciences organizations in mind. To achieve a complete view of your customers across all interactions, the application should be pre-integrated with your customer relationship management (CRM) software so that it functions as an extension of CRM. To support the planning, management and execution of events, the solution should also be open so that it can be used to collaborate with logistics partners.

Veeva CRM Events Management is the solution Veeva customers have been asking for—a single solution to execute better events with greater compliance. By capturing customer data for every event, you can achieve what was once impossible—total visibility of your speakers, attendees and events across all geographies.

Access to physicians has declined steadily since 2008, with about half of physicians in the U.S. placing moderate-to-severe restrictions on visits from pharmaceutical sales reps, according to ZS Associates.

Economic forces and a fierce competitive landscape demand that commercial organizations do more with less. At the same time, changing customer profile information, like office locations, affiliations to larger healthcare organizations, and rules on physician access tests even the best data stewards to keep customer data current. This creates an additional challenge for an already stretched field to effectively engage with their customers.

In order to go to market effectively, you must strategically align your limited resources to the right healthcare professionals (HCPs) and healthcare organizations (HCOs). The practice known as alignment optimization has historically been a painful, protracted process fraught with inefficiencies, errors, and frustration. It is expensive, it requires many data hand-offs between disparate systems and partners, and it is slow. A complete enterprise-sized realignment can take upwards of six months. With the speed in which the market changes, you don’t have time to measure alignment changes in months.

Compounding the issue is rapidly changing customer data. During the alignment process, you are working off of a customer data snapshot that quickly becomes stale. With six-month lead times for a new alignment, even new territory assignments are chronically outdated. So, while your reps should be engaging customers at the start of every new sales cycle, they are instead on the phone with the home office to resolve their alignment inaccuracies. These kinds of inefficiencies lead to poor sales execution, field dissatisfaction and a lack of trust.

Commercial organizations need a new approach to alignments, one that provides new iterations in minutes, not days or weeks, so you know you are allocating your resources effectively. Interoperability with your CRM will enable collaboration with the field for greater accuracy. With a single solution for the entire enterprise, you can leverage the efficiencies of centralized management but still maintain local control.

Although the solution is not easy, there is a means to alleviating many of these challenges. Veeva developed Veeva Align specifically to help sales organizations realign faster and provide sales reps with an easy way to provide feedback on new alignments before they are pushed live. In upcoming releases, you will see how Align enables multichannel and multidimensional alignments, changing the way the industry looks at territories in the future.

Veeva presents 2015 Paperless TMF Survey results at DIA

The use of paper in clinical operations and drug safety decreased significantly, as did the exchange of paper documents between CROs and sponsors, according to findings from the 2015 Veeva Paperless TMF Survey. These are positive indicators of an industry moving away from paper and embracing more mature processes.

I presented results from the survey this week at the DIA Annual Meeting in Washington D.C. As always, the seminal industry event for collaboration and knowledge sharing.

Sponsor-CRO collaboration and the large number of documents managed by clinical operations departments (typically more than half of all TMF documents) are obvious pain points for the industry to start migrating into electronic processes. It was not surprising then to see this drop in paper in clinops and a jump in the use of eTMF applications among sponsors and CROs. Likewise, the fact that almost 60% of respondents electronically archive documents is in line with this industry transformation.

While these are encouraging signs, manual and paper processes remain. Email is far and away the most common method for exchanging documents between sponsors and CROs. Email offers few advantages over paper (It’s unstructured; lacks context; fraught with version control issues; etc.). Less than one third of respondents are leveraging esignature, or ecollaboration, or electronic document creation.

Another important finding is respondents extensively using TMF data see significantly greater benefits, particularly improved inspection readiness and cost savings. This should be a clarion call for the industry to evaluate performance metrics as part of any ROI analysis when selecting eTMF systems.

The 2015 Veeva Paperless TMF Survey is a rich source of data on the maturity of TMF technologies, processes, and metrics. The information in this blog just scratches the surface and I encourage you to download the full report. This type of information is fundamental to learn how the industry can increase efficiency, compliance, and ultimately brings products to market faster.

Kathryn King, vice president of clinical at Veeva Systems

Life sciences leaders from commercial, regulatory and IT disciplines gathered last week at the 2015 Veeva Commercial Summit in Philadelphia. Over the two-day event, they discussed new approaches to promotional content management, shared best practices and joined the Veeva Vault PromoMats community meeting. Peer-to-peer networking among participants provided an opportunity to share unique perspectives aligned on a common goal of simplied, compliant content management.

Consistent themes included the urgent need to achieve global content harmonization and increase promotional compliance, while driving better customer engagement with compelling content.
Key insights:

• Global promotional content management processes and systems are critical to cross-region content harmonization, enabling unified access, content reuse for consistent messaging and cost savings, and system consolidation.
• Defining a global rollout plan is essential—system pilots, regional buy-in, and ongoing governance accelerate the transition to a new system.
• Multichannel communications require advanced content management tracking, search, and reporting capabilities to maintain claims and compliance.
• Flexible systems that manage multiple types of content, beyond promotional assets, are desired. For example, a single system to manage contracts, market research, and promotional materials helps companies consolidate systems and align team efforts.

Meeting participants left armed with new insights, a current understanding of industry best practices, and a host of contacts to help drive greater impact and compliance with promotional content management.

With nearly 1000 attendees, representing 110 companies and more than 25 industry partners, the 2015 Veeva Commercial Summit marked the largest gathering of commercial leaders in the U.S. This interactive forum provided the ideal setting for life sciences commercial, medical, and IT teams to learn, share, and connect.

Customer success, a Veeva core value, comes to life at Summit, where Veeva customers gather to share accomplishments and the latest best practices. In his opening keynote, Veeva Founder and CEO Peter Gassner highlighted customer achievements during the Veeva Heroes Awards ceremony. This year’s 10 Veeva Heroes represented a diverse range of companies—from small biotechs to large pharmas— and demonstrated exceptional leadership, helping their companies thrive in the new commercial world. A big congratulations to all our heroes!

Matt Wallach, co-founder and president, outlined how companies are deploying global commercial infrastructures with Veeva Commercial Cloud today, and described Veeva’s vision for the future. He unveiled the new Veeva CRM Suggestions, which brings the power of data science to Veeva CRM. Now recommendations for the best customer actions and channels are delivered directly within reps’ workflow—allowing customer-facing teams to have timely and impactful conversations with the customer. All reps are empowered with clear suggestions for the next interaction, transforming sales and multichannel effectiveness.

First announced at the 2014 Veeva Commercial Summit, Veeva Align and Veeva CRM Events Management are now generally available. Brian Longo, general manager of Veeva’s commercial products, provided the first look into these offerings.

Tracks dedicated to customer data, medical affairs, and brand management expanded the number of tracks to eight for a total of 60 insightful sessions. With 26 customer and 10 partner speakers, open panel discussions, workshops, and “birds of feather” gatherings, the 2015 Veeva Commercial Summit enabled customers to collaborate, network, and learn from one another.

Of course, fun was to be had by all! Attendees gathered at the magnificent Penn Museum of Archaeology and Anthropology to experience awe-inspiring artifacts from Japan, China, and Egypt.

Year after year, the continued success of Veeva Commercial Summit hinges on the invaluable contributions from our customers and partners. Heartfelt appreciation goes to everyone who helped make this event a huge success. For those of you unable to attend this year, blogs highlighting key learnings from each area of interest will be posted in the coming days. So check back for more details.

Hope to see you next year in Philadelphia or at the upcoming 2015 Veeva Commercial Summits in Europe, China and Japan!

Aggressive timelines, shifting priorities and high stakes business objectives mean there is never an easy time for a life sciences company to implement a CRM system. For firms launching their first product, it’s both more daunting and more important to invest in a system that will help these companies flourish in their transformation to newly-commercial firms

Over a career of five years in life sciences, I’ve had the opportunity to work closely with customers on more than fifteen Veeva CRM implementations. Across all these launches, however, among the most exciting—and the most rewarding—is implementing Veeva CRM as a foundation for pre-commercial clients.

In recent months, I’ve had the opportunity to work on two projects for pre-commercial clients. To help ensure your teams are ready for launch day—fully empowered with Veeva CRM—I’ve compiled some best practices and insights to keep in mind as you juggle bringing your first product to market and implementing a CRM system to help make sure it is a success.

Developing Field Forces

One challenge in pre-commercial client implementation, is that there may be a limited number of stakeholders available during the requirements and iterative review phases. Both of my pre-commerical clients, for instance, were in the process of hiring and developing their field forces during the implementation.

When faced with this challenge, it’s important to clearly identify the key decisions that will lead to a successful deployment. While it’s crucial to prioritize day one needs and focus on essential core functionality to meet your main business processes, it’s also important to take advantage of the flexibility of cloud technology. This involves proactively planning a change control process and release management strategy to deploy enhancements in future releases post go-live. Remember, the speed and configurability of cloud means that functionality which is not there on day one can be released in future implementations.

Shifting Milestone Dates

When working with a pre-commercial client, planning a go-live date that coincides with the commercial launch can be challenging. The commercial launch is often a soft date that is dependent on the drug’s FDA approval. In some instances, the drug may be fast tracked, which will move timeline dates up. It’s important to stay ahead of the curve and be prepared to shift milestone dates to meet your objectives. An expert project team will have experience planning for the unexpected and will work with you to adjust the plan to reach a successful go-live.

Competing Priorities

When companies are ramping up for their first launch, the CRM project is not their only priority. Directors are hiring managers, managers are hiring reps, legal compliance teams are educating the new teams, marketing is working on branding the product and leadership is working to keep all of the pieces together. There is a lot going on and the CRM implementation is competing for time from all of the key players. This can often lead to shifting meeting times and decreased face-time with the business. It’s important to make use of the time you have available with them and be prepared to adjust and stand meetings up on the fly.

Guiding the Client into the Commercial CRM Landscape

Often times, members of the business are learning the rules of engagement on the commercial landscape. When it comes to CRM, you should be able to trust your project team to provide insight and guidance on key decision-making.

Although making the transition to a commercial company can seem like a daunting task, it really provides an excellent opportunity to set yourself up for success with the right commercial operations. Cloud-based and built specifically for life sciences, Veeva CRM is designed to help companies deliver a customer-centric, tailored engagement strategy across all channels. And along with cloud technology and industry expertise, a strong customer success focus is built into our DNA—meaning that we’re with you every step of the way.

Multichannel excellence requires a deep understanding of the customer journey, enabling the delivery of relevant, timely, and compliant communications through all personal and digital channels. At the 2015 Veeva Commercial Summit, industry leaders shared new best practices for personalizing customer interactions across all channels.

Understanding the Customer Journey Enables Relevant and Timely Communications

Companies of all sizes came together to discuss how to eliminate barriers between sales, marketing, and IT—creating fully coordinated customer engagement strategies.

Key insights:

Utilizing data science to improve customer engagement was another hot topic. Sessions covered cases of using powerful data science tools to make the field force more effective—elevating reps to active conductors of orchestrated messages. Empowered by data science, reps can now receive recommendations on the right actions to take based on customer behavior and preferences, and drive customer conversations utilizing the right channel mix. During the interactive expert panel, “The Role of the Rep of the Future,” life sciences leaders discussed the evolution of the field force—and the change in the field’s relationship with marketing, medical, and access teams. Highlights included:

Attendees discussed the increasing use of social networks to better understand and engage customers. A number of sessions provided guidance on how companies can benefit from social channels in a controlled and compliant way. Social networks are also an excellent source of information about customer preferences. Experts discussed extending KOL engagement with social relationship maps and sentiment analysis, and outlined a new approach for personalizing customer interactions.

Veeva Commercial Summit 2015 showcased the innovative ways companies are increasing efficiency, delivering a better customer experience, and improving their commercial models. Let’s keep the conversation going, and take advantage of the growing opportunities for differentiated, customer-centric multichannel interactions.

To maintain business flexibility and a positive user experience over time, every business needs a smart approach to change control. On one hand, over-inflated processes limit the responsiveness needed to quickly react to change. On the other, a lack of formal procedures can lead to poor user adoption because a system that changes too frequently or too drastically can inhibit user satisfaction.

Establishing a formal procedure to make changes to Veeva Commercial Cloud helps ensure the business gains maximum value from its investment. For example, making sure systems can talk to each other across technologies is an important key to efficiency. For vital processes to continue to function after any configuration changes, it’s crucial to consider integration concerns along with any changes to Veeva.

Creating strong, detailed rules and policies to govern change control helps avoid the risk of excessive flexibility, which could lead to an inconsistent user experience. Additionally, robust change control policies ensure users aren’t hampered by narrow or limited-use configuration. Change control ensures all requests are properly evaluated and have long-term viability prior to release.

However, too frequently, change control takes on a life of its own, putting process and documentation itself above the goal of maintaining a healthy and responsive CRM system. A change control process that demands exponentially more time and resources than is required to make the actual change is counter-productive. A cumbersome process can deter users from making valuable system change requests—just to avoid the headache of the change control process. Processes that require multiple layers of administration may lead to approvals by individuals who do not have working knowledge of how the requested changes may impact the system as a whole. At worst, over-engineered change control policies can hinder the speed of Veeva Commercial Cloud by reinforcing legacy processes Veeva Commercial Cloud was meant to replace.

By bringing change control into the cloud for greater visibility and better process management, Veeva CRM can help ease the pain of change control. Managing this process in the cloud eliminates the need to download and locally save information to revise change control documentation, provides real-time update capability and ensures requests are accessible throughout the change control process. Veeva CRM can be enabled with the PMO Toolkit during any Services or Managed Services engagement. This toolkit allows companies to easily centralize user requirements or system enhancement requests in a single location—enabling easy tracking and planning of releases. Teams can create, update, and track improvement projects in the cloud— removing the burden of resource-intensive change control procedures that simply add manual labor. Striking the right balance between process control and flexibility will help companies appropriately manage change—and ultimately, create a strong foundation for their commercial operations with Veeva Commercial Cloud.

Life sciences companies will soon be required to submit promotional materials electronically to the U.S. Food and Drug Administration, according to FDA guidance issued earlier this year. But the time to act is now. As of June 15, 2015, the FDA has opened its doors to accepting electronic submissions.

The move to digital, rather than paper, submissions is an important sea change. The risks and inefficiencies associated with sending CDs—or worse, stacks of paper documents—down to the FDA will soon disappear. For companies with an upcoming product launch, submitting promotional materials digitally now will eliminate the need to switch submission formats midstream.

Many life sciences companies are responding to these new regulations by investing in an electronic promotional content management system, which keeps them ahead of the next requirement and ready to share, update, track and submit all promotional materials in a compliant digital format.

At Veeva, we readied our customers for these industry changes some time ago, and can help companies make a smooth transition to these new regulations. With Vault PromoMats users can automatically generate submission-ready forms and create a bulk package consistent with the latest eCTD data requirements.

To further facilitate electronic submission, Veeva has partnered with leading publishing providersto establish integrations between our solution.

As life sciences companies are readying for eCTD, many are taking the opportunity to invest in systems that stay ahead of evolving regulations and don’t prompt a new software upgrade every time the rules change. This is a key benefit of multitenant cloud solutions, which simply deliver new innovations to all users faster, typically at least three times per year, without the added cost or delay of upgrades. A great example is Veeva Vault, where users are already performing digital FDA submissions today—proof of the benefits of this rapid innovation and delivery.

Talk to us about how Vault PromoMats can help your business leverage the efficiency of the new eCTD guidelines and keep you in compliance, effortlessly. Learn more.

Version 3.0 of TMF Reference Model was published on June 16, 2015, marking an important milestone in the evolution of this popular industry initiative. As the “Controller” (Project Manager) for TMF RM v3.0, I had a unique perspective on this industry-wide collaborative effort. For almost eight months (October 2014-June 2015), more than 100 volunteers contributed or reviewed material and worked diligently to further this shared asset.

Use of the TMF Reference Model has grown to the point that it has become a near-standard reference for clinical development organizations worldwide. The model fills a significant gap in regulations & guidance – ICH GCP does not provide a comprehensive list of contents for a trial master file.

The model is organized into “Zones”, “Sections”, and “Artifacts” — a common misconception regarding the model is that the artifacts are intended to be specific records. While some artifacts are specific (e.g., FDA 1572), most artifacts are, by design, “buckets” into which many kinds of records would be filed (e.g., IP Shipment Documentation). One of the most important changes in the new version is the addition of a column for “Sub-artifact Examples.” Adding this new column should help drive understanding of this key concept by providing companies with a clear place to document the mapping of their company specific records to the TMF Reference Model. In version 3.0, example sub-artifacts are also provided with the intent that organizations adopting the reference model will map and overwrite those examples with the specific names of the records called for in the organization’s’ SOPs. Such a mapping exercise is step 1 for any organization that wishes to adopt the model.

The project team was very careful with content changes, thus the volume of such changes was kept fairly low. A few highlights:

Several ancillary deliverables were developed to coincide with the publication of the new model version. These include:

These deliverables are and/or will be made available to the public via the TMF Reference Model website.

The consensus I have heard from Veeva customers is an eagerness to begin using v3.0 of the model. As a volunteer who has worked on the TMF Reference Model for nearly four years, this is a great sign – many of these companies used their eTMF implementations to introduce the model to their organization, and using it has simplified communication with internal and external team members. With more volunteer power than ever behind the model, I look forward to hearing the additional benefits that version 3.0 will bring our customers and the industry as a whole.

As sales and marketing executives acknowledge, successful multichannel engagement requires a deep understanding of the customer. Master data management (MDM), the process of creating a trusted, single view from multiple sources of information, establishes this critical foundation. Working from a single view, or ‘golden record,’ life sciences companies can create more targeted interactions, delivering relevant information at the time and place of the customer’s choosing.

At the 2015 Veeva Commercial Summit, industry practitioners and data management experts described their experiences and best practices for successful MDM projects. They shared key insights, including the following:

Global healthcare leader Eli Lilly placed organizational change management at the center of its MDM project plan. Data management leads Ashley Kalmbach and Mark Kopetsky first aligned with executive leadership on project goals. Throughout the project, frequent communication with senior management and field stakeholders allowed them to answer questions and address outstanding concerns. And despite some unanticipated speed bumps, Kalmbach and Kopetsky succeeded with a project that is helping Eli Lilly to improve customer centricity at all touchpoints.

Specialty pharmaceutical company Medac Pharma knows that a trusted, single view helps raise the bar on customer engagement, enabling sales representatives to conduct more meaningful conversations. Adopting a phased approach to their customer master rollout enabled Medac’s Michael Henrick and Glenn Tate to first deliver quality HCP and HCO data to sales, in order to support new product launches. Beyond the basics, they also identified the compliance and marketing teams as key stakeholders, and planned for additional uses of customer master data to improve Medac’s commercial operations both near and long-term.

Aggregate spend disclosure requirements are top of mind for life sciences companies. But when it comes to producing transparency reports, these firms are challenged to recognize their customers across multiple systems, such as CRM, Events, and Samples Management. As a result, they may file inaccurate reports, and possibly incur financial penalties. But as Veeva’s Lynzee Collins explained, master data management can help pharma companies more easily identify the people that have received promotional funds – even when they look different among various systems. With MDM, life sciences organizations gain a consistent view of the customer, improving support for compliance reporting and reducing the risk of inaccurate reporting and penalty assessments.

There are new master data management innovations in store for Veeva customers. To learn more, listen to my podcast on the vision for Veeva Network.

Over the past six years, the number of life sciences data providers has shrunk, leaving the remaining providers with little motivation to innovate. Similarly, data technology has remained static, with few providers fully leveraging advances such as the cloud. Meanwhile, life sciences companies are struggling data limitations that prevent them from meeting regulatory needs and effectively interacting with customers. Ultimately, life sciences companies are disadvantaged in reaching their full potential as improvements in the quality of data and services decline.

Customer data is paramount—but quality is a challenge

The disconnect can be seen in the fact that 88% of life sciences executives believe that customer data is a top priority for their organization, and yet 86% believe that data quality is lacking, according to a recent survey results*.

Moreover, the need for consistent, cross-border customer data has never been more urgent. Only 28% of respondents say that current data allows them to fully manage healthcare professional (HCP) engagement across geographies. This global and regional visibility is critical for compliance and transparency.

Clearly, life sciences companies are not getting what they need from their customer data. But that does not have to be the case anymore. Trends in customer data are changing. Data management experts at the 2015 Veeva Commercial Summit described the evolution, referencing three main themes:

Leverage Single Sourcing to Optimize Efficiency and Quality
Reliable and complete customer data is the lifeblood of commercial life sciences, enabling everything from customer engagement to compliance. Selecting a single provider for all kinds of data including compliance data, KOL data, email data and customer data is a prerequisite for a complete and accurate multi-country data with comprehensive HCP tracking. Minimizing the number of data integrations and maintenance greatly improves data quality.

Feel the Need for Speed
Many life sciences companies have simply accepted the status quo: some providers can take a month or more to process Data Change Requests (DCR). But it doesn’t have to be that way. Commercial teams now demand faster DCR response times from their data vendors.
It’s all about agility. Sales reps are working from their mobile devices, looking up HCP profiles and changing call plans on the fly. The faster they can receive DCR updates from their data vendors, the sooner they can efficiently update their call plans for the week. Why not make your data provider accountable for being a partner in data quality over time, suggested experts at the conference.

Predict Future Data Costs
The market now expects to be charged for every single use of the data, taking it from a capital expense to an operating expense.
A simplified, cost-effective data pricing model is needed to ensure predictable budgeting and improve return on investment. With predictability and insight into future data expenditure, commercial organizations can maintain their budget more consistently.

Session attendees also discussed both long-standing challenges, like data accessibility, as well as new breakthroughs. Innovations in data science and analytics, for instance, are now allowing commercial organizations to better engage customers. Vast volumes of data—including information on customer behavior and preferences derived from CRM—are mined to deliver customer-facing teams concrete, actionable recommendations on creating the most effective interaction for a particular HCP. This capability gives clear guidance on the best channels and messages, allowing companies to provide more coordinated, customer-centric experiences.

Data challenges are among the most vexing, and pervasive, in life sciences. Commercial excellence largely relies upon customer information—and improving the delivery and quality of data is a key component of the Veeva OpenData vision.

We will continue conversation during the Veeva European Commercial Summit on 2-4 December, 2015! Click here to register.

* Source: Veeva Systems, “European Life Sciences Industry Survey on Customer Data, May 2015“ final results. Download the summary of Preliminary results.

If you feel like your company is struggling to manage the exponential growth of promotional content, you’re not alone. The rising number of engagement channels, stakeholders, and customer-facing personnel make it increasingly difficult to keep track of where claims reside in the public domain. Add to this mounting regulatory scrutiny, and it’s clear that failing to adopt a new content management approach opens life sciences companies up to significant risks.

While many companies do maintain a brand book or core claims guide to document approved claims, these paper-based or static online resources are often outdated shortly after completion. This leaves your business open to a number of risks. On the marketing front, discrepancies between different versions of a brand book hurt the harmony of the message. From a compliance standpoint, the lack of an up-to-date list of each instance of a claim across all promotional materials could hamper speedy resolution of a regulatory action.

So what does the next generation of promotional content management look like? Instead of paper-based or static online methods, current best practices in promotional content management include an integrated, searchable solution to track, review, approve, and remove each promotional claim. Here are three key capabilities that form the backbone of a complete claims management system:

Next generation promotional content management helps companies reduce regulatory risk by improving visibility into documents and individual claims at every stage. Automating manual processes makes it easy to track, amend, or remove promotional assets if necessary, simplifying regulatory compliance. And streamlining the entire promotional content management process—from creation to expiry—speeds time to market for new materials.

A transformation to this new claims management approach will require time and resources. If you’re ready to take the plunge, here are some next steps:

The upfront investment will yield dividends for years to come in terms of improved operational efficiency and greater harmony of message among all stakeholders. A new claims management strategy will also help your company keep pace with changing regulations, and ensure you can quickly and confidently respond to any regulatory action. For further guidance on transitioning to the new model of promotional claims management, download this new white paper providing detailed guidance and industry best practices.

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The new approach to promotional claims management improves both compliance and efficiency—as content volume, communication channels, and regulatory scrutiny increase. Read the blog on new strategies to manage complex promotional content needs.