Why Joining a DIA Working Group is a Win

By Keith Parent, CEO Court Square Group, and active DIA member

Have you ever wondered what motivates businesses people to commit their time to industry association committees when their calendars are already packed? One answer may be that by working with professional industry groups like DIA (Drug Information Association) you can play an important role in shaping the thinking around the key issues impacting our industry.

As the CEO of Court Square Group, I have been involved in the DIA working group tasked with putting together the second version of the “Framework for the Destruction of Paper.” When I was first asked to join this group, the name “Framework for the Destruction of Paper” sounded odd to me. I later found out that the DIA Document and Records Management (DRM) community was behind the effort because they wanted to help people understand the possibility and path to realizing a paperless office environment. Given the volume of physical documents associated with clinical trials, this seemed extremely ambitious. In the Life Science world, the FDA and the other countries’ health authorities have extensive regulations on record retention and physical vs electronic signatures. Guidance from people in the trenches – documentation specialists, quality managers, regulatory people, technologists, and other focused groups – looking at each aspect related to eliminating paper helped make a challenging task seem much less insurmountable.

After attending the DIA RSIDM (Regulatory Submissions, Information, and Document Management Forum) meeting in Bethesda, MD in February, I was honored to be asked to participate in the DIA RIM (Regulatory Information Management) working group. In our first meeting we discussed putting together the next version of the DIA RIM Reference Model. Through my client work at Court Square Group and RegDocs365 I was already familiar with the DIA EDM (Electronic Document Management) and eTMF (electronic trial master file) reference models since we work heavily with those and interface with a number of RIM applications. I thought this would be a group where I could both contribute real world experience and learn about how colleagues at Sponsors and CROs and Service Providers were viewing the world of RIM and all of its nuances.

The DIA RIM working group broke down into several different streams and I was asked to participate in the AI (Artificial Intelligence) and the white paper sub-groups. My involvement in these sub-groups gave me the opportunity to work closely with other regulatory professionals who are experiencing the same issues, pains, and drivers that most of our customers face every day. Through my involvement in these working groups I have learnt more about how the existing best practices are being utilized within the industry. More importantly, I have also been able to share with the group learning from several current client projects. These have helped provide a framework for others who are tackling similar issues within their own organizations.

If you are looking to expand your professional network and are motivated to help drive progress in our critical life science industry, then I highly recommend getting involved in some of the industry working groups. Giving back to our industry will give you satisfaction that is even more rewarding than completing a project for your company or your client. I recognize that many people may never read the documents that our group of 30 – 40 people has been meeting regularly to pull together. But I also know that some people will end up with work responsibilities and in roles that they weren’t counting on. For those people, going to the DIA community and finding our work will save them the significant effort of having to develop these conclusions on their own.

I encourage anyone with specialized industry knowledge to get involved in a DIA community, share your time and expertise, and to make your mark on our ever-advancing industry. Investing your time will be a win for the industry, and a win for you.