US-based ACI claims the platform can help sponsors reduce time and costs, avoid conflicts of interest, minimise management burden, and identify and contact suitable committee members.
Sponsors using iCommittees can outsource the admin associated with committee management and the task of finding committee members. These committee members can then meet in the iCommittees portal which provides a secure electronic platform for conducting the review.
“For our sponsors, we remove the hassles of recruiting, qualifying and contracting expert clinical and statistical consultants. We also can provide full biostatistical support”, said Kimberly Warner, senior director of client services and regulatory affairs at ACI.
Warner said that since public trust is essential “clients want assurance that the clinical endpoint adjudication and the DSMB or DMC process will be handled with the highest level of scientific rigor and with the regulatory compliant documentation and notification”.
iCommittees achieves these goals by combining ACI’s experience in operation and management of DMCs and endpoint adjudication with a regulatory-compliant technology platform and a global network of scientific experts.
The platform has also been designed to benefit committee members. Warner said: “For our endpoint adjudication or DMC/ DSMB committee members, we remove the administrative burdens so they can stay focused on the important scientific issues.”
Meeting materials and clinical case files are all stored in one place for access by authorised individuals. Furthermore, clinical data is delivered on-time to support decision making.