The Litera Microsystems staff recently got back from DIA Global’s RSIDM 2019, the Regulatory Submissions, Information, and Document Management Forum. This is one of our favorite life sciences conferences, as it does a terrific job of covering the waterfront, educating professionals who are brand new to the industry while providing key updates and helpful advice to those, like us, who have been in it for years.
This year, RSIDM started with a full-day course, Primer: Regulatory Content and Submissions—Content from Authoring through Archive, which explained “the full spectrum of the regulatory submission, information and document management arena.” After this soup-to-nuts breakdown of the lifecycle of regulatory documents from authoring and publishing through submission and archival, the main conference got underway, starting with an outstanding keynote address before administering a shot of inspiration and a continuous flow of helpful advice from experienced experts.
First, Some Needed Perspective on the Patient Journey
There’s a reason we do all of this: because patients are waiting for treatments that may improve the quality of their day-to-day experience with illness or even save their lives. In our own hectic daily workflows, the patient perspective can sometimes fall out of focus. That’s why we were thrilled that RSIDM started off with a keynote address from T.J. Sharpe, a patient advocate, about the ripple effects that clinical trials have on the biggest stakeholders of all: patients. As a survivor of Stage IV melanoma and a clinical trial participant himself, T.J. reminded us why we do what we do and how we can help patients by streamlining our own work processes.
A Dose of Inspiration
With our feet firmly planted on the ground of the patient experience, we dove into an inspiring mix of innovative technological approaches that are disrupting the old approach to document management. We attended numerous sessions about how artificial intelligence (AI), machine learning, and natural language processing are enhancing efficiency in authoring, submissions, and archiving. While stringent regulatory demands have a tendency to stifle innovation and technological exploration, we’re glad to see that the tide is turning and excited about how these technologies can help regulatory document managers assemble and complete their work faster, without wasting time on repetitive and error-prone tasks.
In particular, we were interested to hear how other organizations are using AI to streamline their authoring workflows and manage both structured and unstructured content. We’ve seen firsthand how AI can help extrapolate patterns in regulatory documents and identify commonly used language to accelerate the writing process, getting valuable content into the hands of key users exactly when and where they need it. We’ve been applying the advantages of AI and content providers to our Content Companion, which allows integration with third-party data systems, and we had a number of excellent conversations about how we can help.
And Finally, Some Real-World Advice
Often, industry conferences are more about getting fired up than they are about gaining practical knowledge that attendees can apply when they return to work freshly inspired by the possibilities they’ve learned about. Not here. RSIDM was packed with experts who offered advice based on years of practical experience and hard-won lessons learned from on-the-ground practice. We especially enjoyed an interactive panel that reviewed the results from an industry survey on the use of AI in the life sciences, including use cases. This demonstrated not only where we’ve already made headway with new technologies but also where we should focus our efforts next. We also appreciated discussions about budgeting for technological spending and proving the return on investment from new tools and services.
If you haven’t attended RSIDM before—or if you missed it this year—make plans now to attend next year. It’s the best place to learn, gain inspiration, and network with other regulatory document professionals. We wouldn’t miss it!