Recently the FDA and other regulatory agencies have been recommending independent reviews of safety data. We considered these clinical event committees (CEC) a type of EAC which most often focuses on specific class labeling issues. Like our other EAC, these committees use:
Since the objective of our "On Demand" safety EAC is to independently adjudicate adverse events regardless of causality, we are able to provide sponsors with a cost efficient adjudication of AEs by adding additional adverse reaction assessments to our standardized ongoing safety assessment committees. All our standard safety committee solutions have recently been reviewed by the FDA and comply with regulatory requirements.
Our cardiovascular event committee, also called major adverse cardiac events (MACE), consists of leading experts from Massachusetts General Hospital. Potential events of interest are stratified by type, cerebrovascular or cardiovascular. An automated software workflow engine triages the cases to either stroke neurologist or cardiologist. Imaging data, if available, is also provided to the independent reviewers which increases their assessment confidence. Our committee uses the recent FDA recommended "Standard Definitions for End Point Events in Cardiovascular Trials". For sponsors who have ongoing cardiovascular endpoint committees, WCC has experience mapping prior dictionaries onto the new standard definitions and provides complete backward compatibility. Our board certified subspecialty experts have demonstrated excellent agreement for the assessment of major adverse cardiac events (kappa scores >0.8).
Our malignancy EACs consist of research Oncologists from Harvard and certified cancer tumor registrars to capture all attributes related to tumor typing using the most current cancer dictionaries. Imaging data can also be assessed by the reviewers.
We know it is important for your safety reviews to be done fast. We have taken measures to train board-certified, practicing radiologists to be ready to complete assessments within 24 hours of receiving scans – any day of the week from around the globe. If necessary, we can deliver those reads even faster.
Efficacy assessments in imaging are often facilitated by a batch review. This causes extended delays in determining incidental safety findings. By adhering to our commitment to bring the fastest safety review turnaround in the industry, those delays can be cut to a fraction of the time.