For those of us on the services side of the life sciences industry, connecting with industry clients and colleagues is crucial to ensure changing needs are addressed. The 2019 Veeva Global R&D Summit, held in Philadelphia from 8 to 10 September, was a golden opportunity to connect with industry leaders, hear about pain points and advances in areas such as regulatory information management (RIM), and share common objectives.
As a Veeva Migration Services partner, fme was a key sponsor of the summit and we were excited to be part of this growing industry event. During both days of the summit, sessions were separated into tracks: clinical operations, clinical data management, quality and manufacturing, regulatory, the Vault platform and innovation theatres. A total of approximately 400 life sciences companies attended and 61 spoke at the summit.
One of the newer Veeva Vault initiatives is Vault RIM and Veeva has been proactive at making product enhancements based on customer feedback. A key part of moving to RIM is data migration, which is often a complex and time-consuming process. Ultimately, the time spent on the migration is worth the effort since a centralized RIM capability, such as Veeva RIM, is a game-changer for companies.
Moving to a shared data model
A common challenge for many companies is managing product changes, or variations, after receiving approvals, because information is typically not in one place. Veeva and fme client Vertex spoke at the summit about the benefits of having a shared data model within a unified RIM platform. Not only was there a business benefit to this approach but it also helped to align with their objectives of meeting their commitments to patients. Pharma giant GlaxoSmithKline also spoke at the regulatory session about their journey toward unifying regulatory processes and how Vault RIM is helping them to integrate teams in different countries. The ability to simplify deployment and streamline implementation will also be key to ensuring pharmaceutical companies meet their RIM objectives.
Clinical Data Management
Another key track was clinical data management, with a session focused on building and running complex trials using advances in monitoring, cleaning and reporting data. Integral to this is the migration and management of safety data. As companies begin their transition to a more integrated approach to clinical data, they will need to consider their safety data migration fully and carefully.
It was also great to recognize and celebrate Veeva Heroes, which honors six industry pioneers who over the year have gone above and beyond to help move the industry forward. These innovators have pushed boundaries and navigated change at their company to improve processes and deliver outcomes. This year’s innovators included: Jennifer Trundle, Gilead Sciences; Joe Brenner, Johnson & Johnson; Lisa Little-Tranter, Lilly; Michelle Harrison, Vertex Pharmaceuticals; Sandra Freeman, Johnson & Johnson; and Shelly Plapp, Melinta Therapeutics, Inc. Congratulations to everyone.
The Veeva Vault Summit continues to grow and attract increasingly large numbers of life sciences companies that are eager to learn more about areas integral to their business. In fact, the summit has become so large that during this year’s keynote speech organizers had to use an overflow room to accommodate the audience. Next year’s session, which will be held in Boston, will undoubtedly take these large audiences into account.
In addition to joining the 2020 Veeva R&D Summits in both the US and Europe in our capacity as a partner, fme is also planning to sponsor the Medical Device & Diagnostics Summit to be held in Minneapolis in June 2020. Hope to see you there!
Life Sciences organizations are always under pressure, working with ever-expanding regulations and having to ensure that processes are documented and documents are stored securely.
On top of that, there are additional challenges as a result of mergers and acquisitions. Once they come together, companies are forced to consolidate documents and data from different systems and sources. Further, there is high pressure to reduce the on-premise footprints of enterprise applications – and with that, maintenance and personnel costs.
So, it’s always good to keep on top of these trends and get the latest solutions available to respond to these changing dynamics. We were happy to join the > OpenText Enterprise World Conference in Toronto earlier in July to hear the latest news.
Content migration projects are complex and time-consuming. It’s well understood that time needs to be devoted to planning and identifying the data for systems migration. But many organizations overlook the importance of master data management. This oversight can create huge problems when executing a data migration project, leading to significant delays.
Whether you’re undertaking a first-time implementation of the OpenText Documentum for Life Sciences Quality and Manufacturing solution or you’re migrating to the platform from another software solution, you’ll want to employ a best-practice-based approach to ensure you’re setting up your organization for a stress-free implementation.
After all, the sheer volume of content can be overwhelming and the potential to change business processes that developed over time can be a contentious point in any organization. This planning checklist can assist in making the transition as painless as possible and put your organization one step ahead in planning and implementation.
Misalignment of teams and failure to meet project goals and timelines are an all-too-common problem with big technology projects. Many life sciences businesses have gone through this experience when deploying, migrating, and managing Electronic Document Management Systems (EDMS) and the ancillary systems they support.
Typically, teams or committees are created across different business units and geographies, each with different goals and expectations.
Markus Schneider, Managing Consultant and Life Sciences Expert at fme AG in Frankfurt, is one of the leading migration specialists in Central Europe. He is leading a team of application- and content-migration experts focused on the Life Science and especially the Pharmaceutical industry.
Whenever you start thinking about data migrations, it’s almost impossible not to jump to all the potential challenges. Even the most well-run projects can be derailed at any point. That’s because most migrations are often complex efforts that require detailed planning that takes into account how users are going to conduct business during the transition phase without the pain can frequently accompanies the migration.
It’s all about how to transition data fast and securely with minimal downtime or disruption to the organization and employees. But that’s much easier said than done in most environments – especially when you start thinking about the scale of content to be migrated and what’s technically required to make content “discoverable” through search so users can locate their documents quickly.
Networking and learning from the experiences of other organizations is integral to business growth. That is the primary objective of the one-day Life Sciences User Forum (LSUF) meeting sponsored by fme and OpenText.
The meeting held in April brought together business and technical leaders from within regulatory affairs, quality, and IT to share their experiences with regulatory content management strategies, technology implementation challenges, and leveraging next-generation digital tools to automate and improve business processes.
At the end of August I was able to attend the BoxWorks conference in San Francisco, subtitled “The Future of Work”. I have to admit, I went there with only a little pre-knowledge and with the history (baggage?) of being a long-time Documentum consultant.
Let me start with a quick summary of the highlights:
Box Feed (available as Beta)
Box feeds allow you to get a stream of activities happening in the shared folders which the user can access. This is a nice collaboration function as are you are seeing the content of your coworkers directly in the stream. This has been missing for a while and Box is now delivering a first iteration with the possibility for you to comment on the documents.
It’s been very interesting to watch how the Cloud has had an impact on Enterprise Content Management in the Life Sciences market over the past year or two. I doubt that there are too many observers with knowledge of the market that believe that its impact has been anything other than positive. But as with most “no brainer“ disruptive technologies, it’s still finding that the path to adoption is not quite as simple and straight forward as it might at first appear.
Clearly, the opportunity for Life Sciences companies to outsource their IT infrastructure and some related services is a derivative benefit of utilizing Cloud. In addition, subscription pricing, synonymous with Cloud solutions, has the benefit of moving CapEx to OpEx and realizing the financial benefits of doing so, appeals to many companies.