Overview

Clinical trials oversight by a Trial Steering Committee (TSC) is mandated by Good Clinical Practice. The role of the TSC mem- bers may change depending on how well a trial is doing, from rubber-stamping when things are going well to being more critical and directive at other times. Regular and on-time discus- sion and feedback 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 suc- cess of Medicinal Product on the market.

Challenge

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 a digital platform will help to en- sure 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.

Approach

Find digital solution which facilitate the discussion, advice and decision-making process for the regular communication be- tween Steering Committee members and Sponsor of the trial. The platform will notify Steering Committee 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 ef- ficiency, transparency and quality of interaction.