Case Study #2

Clinical trials oversight by a Trial Steering Committee (TSC) is
mandated by Good Clinical Practice. The role of the TSC members may change depending on how well a trial is going, from rubber-stamping when things are going well to being more critical and directive at other times. Regular and on-time discussion and feedback on how to deal with the issue management, as well as regular amendments to the Protocol might influence the overall results of Clinical trials and as the consequence the success of Medicinal Product on the market.

Taking into account competing engagement of leading experts
into multiple scientific bodies including numerous Clinical Trials Steering Committees, and the pressure of extensive traveling with additional complications with COVID-19, the solution with an easy connection through the digital platform will help to ensure availability and participation and could become the new approach in organizing the work of Steering Committees. The security and data protection become as one of the key points considering the Confidentiality of such discussion.

Find digital solution which facilitate the discussion, advice and decision-making process for the regular communication between Steering Committee members and Sponsor of the trial. The platform will notify the members on all inputs they need to provide, tracking if any inputs are missing. MphaR Virtual Advisory Board Platform was chosen to run this event in digital format to collect the advice, evaluation and align on the next steps for the Steering Committee. Improve the efficiency, transparency and quality of interaction.

01

Session 1 (3 days)

Pre-read activities: get familiar with all documents uploaded into E Library

02

Session 2 (8 days)

Provide feedback on protocol design and e-CRRF using platform annotation features

03

Session 3 (5 days)

Discussion Forum: Steering Committee members provided feedback about a critical part of the protocol, evidence data gaps, and publication plan