Several of us at Litera Microsystems recently returned from the 2018 Regulatory Submissions, Information, and Document Management (RSIDM) Forum in North Bethesda, Maryland. This conference has been growing consistently every year and has become a can’t-miss event. We love hearing about recent developments and current concerns within the life sciences industry. The RSIDM Forum is a wonderful opportunity to be surrounded by regulatory professionals, medical and technical writers, and clinical researchers: the people using our products every day, on the ground, in real-life scenarios, who can tell us what’s working for them and what needs improvement.
The RSIDM Forum offers a slew of specialized educational tracks in addition to general plenary sessions, networking opportunities, and of course a vendor exhibit area, where we spent much of our time. Here are our key takeaways from the presentations we attended and the conversations we had at this year’s meeting.
This year’s presentations covered the waterfront as far as document technology: we heard discussions about blockchain, artificial intelligence, and the value of innovation. We also checked out sessions about optimizing electronic common technical documents (eCTDs). RSIDM always offers useful regulatory intelligence updates, presented by U.S. FDA and Health Canada representatives.
Of the four continuing educational tracks offered this year, three of them were right up our alley:
Sessions on regulatory information management (RIM) technology, which focused on the standards and tools for submission and management of regulatory information,
The electronic regulatory submissions (ERS) track, offering best practices in regulatory submissions, and
The electronic document management (EDM) track, discussing content management across the product lifecycle.
It’s exciting to see that other professionals are also working toward unifying and integrating data to provide maximum benefit and inform business decisions across a product’s lifecycle.
In addition to the sessions we attended, we enjoyed countless conversations with current and prospective clients as well as other vendors and regulatory professionals. We repeatedly heard about the importance of document consistency and validation from creation through submission. Rather than just working with a single team within an organization, there’s a greater effort today to harmonize these functions across entire companies, aiding cross-project collaboration and internal consistency.
We also elicited information about what concerns technical writers and regulatory professionals. Over and over, we heard how many businesses are struggling with updating to Office 365. These businesses have previously incorporated customized code or other homegrown solutions, often to automate and standardize their workflow processes, or have inconsistently applied program upgrades. Now that there’s a stronger push toward updating their software, they’re recognizing that their users—and each version of ad hoc or homegrown software—must be individually prepared for the transition.
In addition to asking questions and listening, we were able to share a beta version of one of our new products, a content sharing and -reuse application. Lots of people said they have been looking for this type of solution—and we were able to sign up several companies to participate in our ongoing beta program. With their early feedback, we hope to roll out this product to the general public soon!
Unsurprisingly, everyone at RSIDM was focused on creating clear, concise, correct documents, as quickly and easily as possible. Looking toward the future and the 2019 RSIDM Forum, we’re all excited to see where vendor consolidation—and the seamless interaction between vendor systems that we hope will follow—will take us.