Clinical Trial Oversight
Looking for guidance on how to best provide safety data review during your clinical trials? Look no further, at Lecuyer Consulting we have the real world experience to help any company identify the best processes for ongoing review of subject safety data. Ensuring data integrity with a clinical focus can ensure that your subjects have better outcomes and your regulatory submissions are more likely to be approved.
Safety Signal Detection and Evaluation
With the most recent FDA guidance on safety reporting, the expectation is that safety signal detection and evaluation is to occur in close to real time throughout the lifecycle of new product development. Due to this, your company may be looking to shift to a proactive approach for aggregated safety data review. Lecuyer consulting can help you develop state of the art clinical analytics tools tailored specifically to your needs. These visual tools can help push the most critical data to the top of the pile for easier trending and signal detection.