Pharmaceutical companies may establish endpoint or adjudication committee to review the study safety or efficacy endpoint, particularly when the end points are subjective and or complex. The adjudication process is quite complex as it involves the sites, sponsors, end point coordinators, access and languages of source records. In addition, with large outcome studies sponsors obtain approval for study end points to be exempted for SAE reporting until the events are adjudicated. However health authorities require the adjudication process to be completed within reasonable time to avoid delays in adverse/serious adverse event reporting. Hence there is cost, complexity and regulatory commitment that requires adjudication process to be set-up carefully from study initiation.
With Tcell, you have access to sophisticated end-to-end electronic adjudication process along with our expertise in managing adjudication in large outcome studies. This facilitates quicker turnaround time and quality adjudication packages that are in compliance with health authority requirement.
We also work closely with the sites and CRAs to ensure endpoint packages are submitted in a timely fashion and you will have continued access to status of end point reporting and adjudication.
We have successfully managed both efficacy and safety adjudication in phase 2 and phase 3 trials ranging from few hundred patients to 10,000 pts including both paper and electronic adjudication process. We have extensive experience working with academic partners supporting adjudication including set-up and training the adjudicators in electronic adjudication process.