ITREAS has extensive experience in enabling the independent blinded adjudication of clinical events for a large spectrum clinical trials, ranging from small scale studies to clinical trials with thousands of safety and efficacy events. We provide extensive adjudication committee management and coordination services to ensure top quality data, an efficient workflow process and on-going quality control, all in line with the ICH-GCP guidelines.
Our quality processes ensure on-time database lock and avoid the usual “panic” around database closure.
ITREAS’ independent adjudication experts are experienced practising physicians specialized in radiology, cardiology, neurology, haematology, oncology, hepatology and nephrology. All members have served on multiple adjudication committees that performed assessments for both registrational and non-registrational clinical trials.
We ensure that sites report high quality data and continuously monitor all available resources to detect safety and efficacy events that require independent review. This translates into expedited review and assessment of both investigator reported events and events triggered from data entered in the eCRF. ITREAS therefore actively promotes and supports best-practices at the site level by training sites on event reporting procedures, as well as diagnostic work-up, and taking remedial action where needed. This guarantees short turn-around times, allowing Safety Boards and Endpoint Committees to monitor the core datasets continuously. Our coordination services additionally ensure on-going reconciliation efforts and timely resolution of queries and discrepancies. This ensures on-time database lock and avoid the usual “panic” around database closure.
We have ample experience in designing and working with online endpoint adjudication systems and we can transfer the blinded and independent adjudications of core efficacy & safety data into each database of your choice.