Your teams have worked hard to meet your NDA timeline and complete your submission to the FDA only to receive a Refuse to File letter. In response, we stepped in to perform an independent statistical review, explain findings to the FDA, and fixed data so the sponsor could re-submit the NDA to the FDA.
An ongoing safety study is struggling to meet its patient recruitment goals. Through site engagement techniques, more patients were recruited in 66% less time to meet study goals.
A high volume of recruitment for a single site, numerous protocol amendments, and the continuous evolution of the project parameters leaves a sponsor overwhelmed. Learn how consistent monitoring with data verification and review get this trial on track.
Our regulatory experts created this guide to highlight the benefits of, qualifying criteria for, and timing and procedures for six different expedited programs and designations. Click below to learn more.
Veristat was asked to help a current client kick-off a phase I COVID-19 vaccine trial. The sponsor had identified sites and patients. The gating factor was to get the clinical trial database built quickly in order to start enrollment and randomization.
