Lessons Learned: Implementing an End-to-end RIM Solution
Every February, regulatory professionals from around the country gather at the DIA Regulatory Submissions, Information, and Document Management (RSIDM) conference to hear about the latest in regulatory innovation from health authorities, experts, and technology vendors alike. At this year’s conference, the concept of “end-to-end RIM” was arguably the most popular topic. From booth demos to sponsor sessions to informal conversations, attendees discussed why a solution that spans submission planning, publishing, and registration tracking is superior in today’s regulatory environment. However, that’s only half the equation. To realize the full benefits of end-to-end RIM, you need the support of a single platform, not a patchwork of integrated systems that are difficult to upgrade and maintain.
Just a few weeks prior to the RSIDM conference, two regulatory operations leaders shared their experiences with implementing an end-to-end RIM solution on a heavily attended RAPS webinar. Both companies adopted Veeva Vault RIM to streamline regulatory processes, and in doing so learned valuable lessons for submission planning and tracking, authoring and approvals, health authority interactions, and reporting.
Christie Hamel, the director of regulatory operations at IONIS, described how her team struggled with siloed information and manual processes, which made drafting responses to health authority requests painfully inefficient. She recalls a team member saying, “I swear I got a question like this before, but I can’t remember in what country and for what compound” and then he’d spend hours digging around for the information. By connecting health authority questions, commitments, responses, and correspondence through a single platform with Veeva Vault Submissions and Submissions Archive, the IONIS team could finally see the complete picture. “Now the left hand knows what the right hand is doing,” said Hamel.
One piece of advice that Hamel shared during the webinar was to get key users actively involved in the implementation and have them test out the data before going live with the entire company. That way you build internal advocates and you won’t get flooded with redundant questions, which can really slow down the overall process.
To hear what other advice IONIS shared for maximizing the benefits of an end-to-end RIM solution, watch the full webinar recording here.