TRUSTED ADVISORS TO HEALTHCARE AND LIFE SCIENCE EXECUTIVES
UNIFYING APPLICATIONS TO DRIVE EFFECTIVENESS,
EFFICIENCY AND COMPLIANT COLLABORATION
By: Sandra K. Rodriguez, Market Analyst
USING A CLOUD PLATFORM TO CONNECT THE LIFE SCIENCE VALUE CHAIN
Pharmaceutical, Bio-Tech and Medical Device companies are increasingly adopting cloud
platforms to drive effectiveness and efficiency throughout the value chain. These organizations
are unifying applications that support the total product lifecycle in a compliant manner, without
losing sight of what matters most – product quality.
This shift from disconnected point solutions to a platform approach became clear at the
Veeva Systems Global Summit for Clinical, Regulatory, and Quality in Philadelphia on
October 17-19, 2016, where I joined over 600 attendees representing 154 companies.
Client presentations ranged from start-up to multi-national Life-Science companies
including Regeneron, Shire and Johnson & Johnson. A list of presenters can be found here.
Jennifer Goldsmith, Senior Vice President, Veeva Vault kicked off the event by celebrating
the five-year birthday of Vault. This was my first time covering the event and I was
immediately surprised by the opening keynote delivered by
Peter Gassner, CEO at Veeva Systems. He revealed that over
the past three years, the company has consistently doubled its
customer base across all three of its product offerings – Vault
Clinical, Vault Quality and Vault Regulatory. Sessions were
offered across all three areas including a track on platforms
and a focus on small and mid-size organizations.
Attending case study sessions and in discussions with
customers during breakfast and lunch, it became clear the rapid growth of Veeva’s
customer base can be attributed to both organic growth, as well as the addition of new
customers.
THE CLOUD PLATFORM
The platform approach appears to be resonating with Life-Science companies of all sizes. Some
of the biggest names in the businesses, as well as start-ups, are taking advantage of Veeva
Vault’s 12 application suite to support a single source of truth across the value chain, from R&D
through commercialization. They seek to gain visibility, drive effectiveness & efficiency and
2016 Axendia, Inc.
UNIFYING APPLICATIONS TO DRIVE EFFECTIVENESS,
EFFICIENCY AND COMPLIANT COLLABORATION
support compliant collaboration throughout the product lifecycle by streamlining workflows
internally and with external partners.
Veeva Vault encompasses the following suites: Clinical, Quality and Regulatory. New
applications include Vault CTMS in the Clinical Suite and Vault QMS in the Quality Suite. Also
announced for Clinical was Vault EDC, planned for April 2017 and Vault eSource planned for
December 2017. These products are all the direct result of the company listening to its
customer base and building addition modules to support their business needs across the
platform. With over 42 million documents currently being managed in the cloud, users are able
to view documents on average within 1.3 seconds.
A RAPIDLY DEPLOYED, GLOBAL QUALITY SOLUTION
Customer presentations focused on rapid deployments and the immediate benefits of
increased effectiveness and operational efficiencies in business processes via a unified
application suite. It became clear during the customer case studies that many organizations
embraced the platform approach because they had simply outgrown their existing,
disconnected systems. Whether home grown or off-the-shelf, they were no longer a fit. In
most cases, they were disparate, silo’d sources of information that supported a paper-driven
process.
One such case study from Shire was unique in that the company it acquired had undergone two
mergers and name changes during the implementation of Vault. However in just six months,
the acquired company managed to successfully transition more than 20,000 internal and
external users from multiple systems to Vault QualityDocs.
Yet with the implementation of any new system or change to an existing process, organizations
face a real struggle when it comes to people changing their behavior. As part of the opening
keynotes, Anthony Waclawski, VP of Global Submissions & Regulatory Policy with Bristol-Myers
Squibb addressed cultural change and how to achieve organizational effectiveness. An
organizations performance ultimately depends on the behavior of its workforce. To achieve
effectiveness, companies must close the loop in three core areas:



Behavior
Cooperation
Effectiveness
To ease the coming transition, the team that successfully transitioned 20,000 users did just that
by building a complete internal marketing campaign announcing the project and an ongoing
communication plan throughout and post go-live.
In smaller companies or start-ups with no existing systems, Veeva is a natural one-stop shop to
manage clinical, quality, and regulatory content and processes. Not only does a cloud platform
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UNIFYING APPLICATIONS TO DRIVE EFFECTIVENESS,
EFFICIENCY AND COMPLIANT COLLABORATION
eliminate the need for a small army to run an IT organization, it eases the pain of validation. By
taking a risk-based approach, bluebird bio was able to reduce the validation effort of a release
from 5 business days to 1. The company owns Vault QualityDocs, Vault RIM, and Vault QMS
and pointed out a standard platform offers countless benefits and creates natural efficiencies in
the business process. Also noteworthy is the consistent user experience across business
applications. Regardless of the size of the organization, companies have a real expectation of
built-in industry best practices to avoid customization.
HOW DOES DATA INTEGRITY ENABLE GOOD DECISION MAKING?
As companies large and small continue to operate in outsourced models ranging from trial
management to research and manufacturing, having a single source of truth for all external
partners is crucial to ensuring product quality. While the operational paradigm has changed,
quality systems and technology infrastructures have not kept pace. As a result, managing
quality and compliance activities in an increasingly fragmented ecosystem is difficult and labor
intensive process.
The VP of Information Systems at a large West Coast biopharmaceutical company pointed out
“information becomes a strategic asset and differentiator for companies that can bring it
together.” His company is not unique in that the majority of their data resides outside of their
own four walls due to outsourced business functions.
However if outsourcing is here to stay, customization is going away. Another rapid deployment
came from a large multi-national medical device, pharmaceutical and consumer packaged
goods manufacturer. The company’s 12-month roll out included 214 locations, 60 countries
and 15+ languages. The team, who stated IT systems are typically customized up to 40% to
meet their business needs, was able to take advantage of 80% of out-of-the box functionality.
Although many of the locations were small (1-20 people per location), templates and workflows
were standardized ensuring ease of use for all locations.
The biggest challenge the team faced was not the timeline, but overcoming the adoption
barrier due to organizational/cultural change management and shifting its user base from a
document-centric to a data-centric environment. Sites had to learn how to manage, analyze,
and organize content using data attributes rather than traditional folder trees. The company
addressed this challenge by building an internal user community that provided a ‘voice of the
customer’ platform for feedback and issue resolution.
There is tremendous power in learning the work of others and through collaborative problem
solving and cooperation. Companies of all sizes are seeking to leverage the Vault platform
across core functional areas for visibility into clinical, regulatory, and quality data and ultimately
pulling it together in a meaningful way.
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EFFICIENCY AND COMPLIANT COLLABORATION
CONCLUSION
Open dialogue between companies about the lessons learned in cultural change management
while attending a technology conference is a refreshing change. Making the shift from paper to
data and leveraging a life sciences cloud for content management is a process, not a project. I
was happy to see the Microsoft Office Online integration, which enables real-time collaboration
by allowing users to share, edit and review documents online. These continuous process
improvements result in a heightened level of quality that benefits all stakeholders, as does
increasing transparency between internal and external partners and throughout the value
chain.
Inevitably the adoption of cloud platforms will continue to increase as life sciences companies
seek to work more effectively outside of their own four walls and increase efficiencies to enable
better business outcomes across the value chain. Effective quality management can unify
internal and external parties and functional areas for seamless change management, risk
mitigation and traceability of events from identification to correction.
Whether a company manufactures Pharmaceutical, Biopharmaceutical or Medical Devices, the
goal is not only to lower costs but to improve on efficiencies and shorten time to market in a
compliant manner, without losing sight of what matters most – product quality.
The opinions and analysis expressed in this brief reflect the judgment of Axendia at the time of publication and are subject to change
without notice. Information contained in this document is current as of publication date. Information cited is not warranted by Axendia
but has been obtained through a valid research methodology. This document is not intended to endorse any company or product and
should not be attributed as such.
About Axendia:
Axendia, Inc. is a leading trusted advisor to the Life-Science and Healthcare industries. We provide
trusted counsel to industry stakeholders on Business, Regulatory and Technology issues.
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© 2016 Axendia, Inc. All Rights Reserved. This publication is copyrighted by Axendia Inc. and protected by United States copyright laws
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Published December 2016
2016 Axendia, Inc.
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