Veeva R&D Summit Puts Focus on Innovation and Best Practices

Veeva R&D Summit Puts Focus on Innovation and Best Practices

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!

User Forum Brings Life Sciences Community Together

User Forum Brings Life Sciences Community Together

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.

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.

To garner deeper perspectives and insights, attendees separated into three groups and were asked to discuss three key topics:

  • Priorities and considerations when deploying an end-to-end regulatory information management (RIM) solution, including technical priorities, platform limitations, and the limitations posed by document and data quality.
  • Upgrading and re-platforming to OpenText Documentum for Life Sciences, taking into account master data management, goals to streamline processes, and compliance or data quality issues that should be improved.
  • Quality management solutions, sharing current experiences and areas that need improvement, managing change control processes, and existing measures to oversee QMS processes.
  • The post discussion roundtable resulted in a healthy and productive exchange of ideas and experiences. These perspectives will be further explored in future LSUF meetings.

    A Focus on Improving Processes

    The effort to improve and simplify processes is a high priority for life sciences companies. Artificial intelligence offers a powerful opportunity to improve document quality, for example by enriching metadata. During the meeting, fme talked about the intelligent document classification and metadata enrichment solution it is developing in partnership with Docxonomy, called fmeMATRIX. As establishment of the solution continues, the views and experiences of clients will be integral to applying a progressive approach. The LSUF meeting was a key opportunity to garner feedback on the needs and concerns of life sciences companies. Here are some additional takeaways:
    • In another LSUF presentation, one of our clients shared its experiences with collaborative authoring, using technology to enable simultaneous or parallel authoring and review in real-time. Integral to enabling the company to meet its regulatory requirements is SharePoint Connector, and the client team is working with OpenText on implementing this capability.
    • During its presentation, the client’s IT account manager and IT regulatory architect posed several key discussion points and questions for their peers. These included how other companies tackle collaborative authoring of submissions and the point at which a document becomes an official record, based on good practice guidelines.
    • During another presentation, a client presented a proven, iterative approach to integrate a leading Regulatory Information Management platform into the OpenText Documentum for Life Sciences Research and Development module. The client outlined an approach that ensured quicker solution implementation timelines and more effective R&D alignment and buy-in.
    These were some of the highlights from the April LSUF meeting, which was the second forum meeting to bring together the life sciences client community to exchange ideas. The next forum will be held this October and we look forward to further productive and insightful discussions. Please reach out to me if you’re interested in joining this growing group!