Clinical Event Management

Designing the most suitable flowchart of event management steps between the different parties involved in this process (i.e. investigator, CRA, event data management, medical review department, translation department, Critical Event Committee (CEC) members and Chairman, Data Safety Monitoring Board, study database management)

Providing appropriate event definitions from our database or supporting the CEC in establishing study-specific definitions

Preparing specific event documents and endpoint reporting manuals

Providing lists of necessary source documents per event or supporting the CEC in deciding on this

Training investigators, CRAs and medical reviewers in study-specific definitions and necessary source documents if needed. Training in electronic data transfer if applicable

Supporting the choice of the appropriate CEC Chairman and members. We have considerable experience in putting together the right CEC for different studies. Key Opinion Leaders (KOLs) in our company have first-hand experience in event adjudication and chairing CECs. Through this experience we are able to help sponsors to select the right members for their trial

Organizing CEC face-to-face meetings (preparation phase and study phase)

Designing a computer-based CEC member selection system for each batch of events to be adjudicated, prompt delivering of member adjudications to the CEC Chairman, listing of final adjudications and of those that need to be finalized during CEC face-to-face meetings

Collecting and transporting logistics of specific event documents, appropriate CRF pages and source documents. Scanning all documents for electronic event reporting and adjudication

Translating all documents. Note that source documents will be translated by local (bio)medical CRAs in all countries in Europe, ensuring full understanding of medical terms and 100% capture of medical data

In-house medical reviewing of all documents and immediate querying of missing data, inconsistencies etc. by our experienced MDs

Setting up a computer-based event tracking system

Controlling endpoint reporting timelines and providing the sponsor with regular updates

Submitting adjudicated events to the study database or separate event database whichever is appropriate

Submitting blinded events to the Data Safety Monitoring Board (DSMB) if required