Classifying clinical trial portals
Monday, June 15, 2015
A popular driver of clinical trial portal adoption is the desire to improve investigative site staff satisfaction by providing integrated solutions that require fewer credentials, less double data entry and fewer manual paper processes. Other objectives include decreasing study timelines (especially site selection and activation), cutting study costs, improving study team oversight and moving to a paperless environment.
The term “portal” is overused in the clinical trial setting, and the problems portals solve are unclear. To provide more clarity regarding portal categories and the features they can provide, portals should be classified by levels:
Level 1—Information-sharing: Able to restrict access to the system and control which studies a user can see; provides basic collaboration tools.
Level 2—Collaboration: Has level 1 capabilities plus role-based access and permissions, offers mechanisms by which study teams and sites can send/ receive files and provides single sign- on to third-party applications.
Level 3—Business-enabling: Offers level 2 capabilities plus a full audit trail and integrated task management and workflow tools.
Level 4—Integrated: Has level 3 capabilities, plus the ability to push/pull data from other eClinical systems and generate integrated reports that show overall site/study progress.
- Achieving desired business outcomes requires certain portal levels: Increase site satisfaction: Reduce the staff need to remember multiple credentials for the various eClinical systems. (Level 2 portal minimum)
- Improve study timelines: Offer collaboration or business-enablement applications. (Level 2 or 3)
- Decrease study operating costs: Reduce task duration by implementing collaboration or business-enablement applications. Automate document exchange with sites and reduce courier costs. (Level 3 or 4)
- Increase visibility and oversight capabilities: Employ a portal that tracks activities, assigns tasks and reports activity within (and ultimately outside of) the portal. (Level 3 or 4)
In addition to categorizing clinical trial portals based on functionality, the industry also should consider collaborating with a standards organization, such as OASIS or ISO, to define interoperability standards.
Written by Guest Writer Lance Converse. Converse is CEO of ePharmaSolutions, a WIRB-Copernicus Group company. Before starting ePharmaSolutions, he founded Acurian, an investigator and patient recruitment company, and ReSearch Pharmaceutical Services, a publicly-traded CRO. He also is a co-founder and board member of two biopharmaceutical companies.
Christopher McSpiritt, practice lead-clinical optimization at Paragon Solutions, contributed to this article.
This article was reprinted from Volume 22, Issue 06, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact firstname.lastname@example.org. Subscribe >>