On day two of the clinTech 2013 conference, I attended the Portals track because Portals are one of the most discussed venues through which Sponsors feel they can improve efficiency and become the “Sponsor of Choice” for the Investigative Sites. The track was chaired by Alison Shurell (IntraLinks) and she opened the day with opening remarks.
Below are summaries the morning presentations and highlighted key takeaways:
Transition to “Intelligent Content”
Michael Brennan Janssen
The presentation was an update on the FDA’s pilot of XML messages for site and trial info. Janssen used the 1572 as an example of study participation information that is submitted to the FDA (currently as a document) and showed how using an XML-based form they could collect this data and submit it electronically. This could be expanded to collect site and vendor/partner information as well as submitted through a common method. Janssen then showed how the same process is being investigated for Patient Narratives. There was a good amount of excitement/interest in this update and I can see more Sponsor/vendors jumping on this ship as it gains more agency acceptance.
Utilize Digital Identity Credentials to Facilitate Cloud Collaboration
This presenation focused on how digital identities can improve collaboration on the cloud. Mollie opened by discussing how the R&D industry is being changed by the “community focus” of sites, sponsors, academia, and government. This focus moves the collaboration outside the boundaries of any organization. This seems like a nice problem to have, but Sheilds-Uehling explained that it causes issues due to organizations having their own processes/standards when it comes to managing digital identities and signatures. Sheilds-Uehling talked about how the SAFE-BioPharma standard could solve these issues by giving a federally-accepted identity to the various collaborators. She went on to discuss the various pilot programs that were underway and how digital identity/signatures had shown impressive time and cost savings.
Complete Management and Oversight of the Clinical Process Across the Global Community Alison Shurell
This talk focused on how cloud-based solutions can improve management of trials. Alison began her talk by adapting a traditional saying to become relevant for clinical trials –“It takes a village to raise a clinical trial”. Shurell went on to say how this was a global village because clinical studies are becoming more and more global in nature. The global nature of studies has increased cost, time, and risk of running a trial, but she feels that an integrated eClinical suite can offset this increase. Shurell finished with showing how the IntraLinks solution can reduce complexity and deliver a solution that all contributors are comfortable with. A key takeaway from her talk was that personalized views/interfaces based on role are a key requirement of a successful clinical portal. Another key takeaway is that there is a need for a better more unified definition of a clinical portal...too many definitions based on biases/audience.
Manage Expectations of Investigators Worldwide Roundtable facilitated by Veeps Piravi and Rachel Belani-Barker
Discussion topics included how Investigator Portals can improve relationships with sites, what you need to do to gain site adoption, and region-specific considerations that need to be taken into account. The discussion was lively as audience members were actively engaged in the discussion. One key theme from the discussion was that getting regular feedback on eClinical systems from users (internal and external) is vital to successful and sustained adoption.
Did you attend this track and/or presentations? If so, let me know what you thought?
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Chris McSpiritt is the Clinical Practice Lead for Paragon’s Life Science Research& Development team. Chris has over 10 years of pharmaceutical industry experience in R&D and has applied his business architecture, business process management, and analytical skills to help pharmaceutical companies improve the conduct of clinical trials for global life sciences companies. Chris holds a BA in Psychology from the University of Notre Dame. He is an active member of the Business Architecture Guild, Association of Business Process Management Professionals, Project Management Institute, and Drug Information Association.