Case Studies – Regulatory Medical Writing
A small US medical device company with no internal regulatory medical writing resources, had identified the need for regulatory writing management and support for a pivotal 1-year endpoint Clinical Study Report (CSR) and an annual report, both with due dates to US and international regulatory authorities within two weeks of each other. Each report was presenting data on different devices undergoing large-scale clinical trials.
The first step with the client was to conduct a resource and gap analysis, which revealed critical staffing needs in the areas of report project management and regulatory writing services.
One regulatory writing project manager (RPM) was assigned to both reports. Meeting with the sponsor’s internal team from biometrics, data management, regulatory affairs and safety, along with the therapeutic area subject matter expert, key timelines and deliverable dates were identified for both projects.
Below is a partial example of the timelines developed by the RPM for the CSR (not actual dates):
Working in parallel with a team of regulatory medical writers, the RPM created the tools necessary to manage multiple report projects with tight, competing timelines. As necessary, adjustments were made to the timelines in collaboration with other members of the cross-functional team. Both reports were ready for final cross-functional check and approval per their respective timelines and were submitted to the appropriate regulatory agencies per the agreed-upon due date. No questions from either regulatory agency were received.