Advancing Cell and Gene Therapy: A Case Study on Rapid CSR Development
Challenges:
A pioneering West Coast US Biotech urgently needed to write the CSR and SAE narratives for their Phase 1 cell and gene therapy clinical trial. The client had a tight deadline to submit the CSR to the FDA within a few weeks. We had to quickly assign writers and quality control personnel to create the CSR and SAE narratives. It was important for us to effectively communicate with the client to manage the required timelines without impacting the quality.
Solution and Results:
Morula Health utilized our global network of skilled Medical Writers to assign a Medical Writer based in the US who matched the Sponsor's specific criteria. This included having experience in writing CSRs related to oncology and cell and gene therapy, and their immediate availability. Our highly skilled Project Manager played a pivotal role in streamlining the entire process. They made sure all necessary source documents were easily accessible on the Sponsor's document-sharing platform, thus eliminating potential delays. Additionally, they organized a productive Kick-Off Meeting. This meeting not only clarified project objectives and roles but also fostered unity and collaboration among team members. The result of such proactive management was that we commenced work on the CSR just 2 days post-contract signing.
Our Medical Writer produced a high-quality and comprehensive first draft within three weeks, which was promptly reviewed with minimal comments from the sponsor and their large Pharmaceutical Development Partner. The draft was quality-controlled according to our checklist and finalized for submission.
Demonstrating our commitment to delivering high-quality work within tight deadlines, this swift response enabled us to deliver this project within a short timeframe, saving valuable review time and resources. It underscores the value we bring to our clients by enhancing the overall productivity and effectiveness of our projects, always striving to exceed Sponsor expectations. As a result of this project, we were able to support the Sponsor in reaching phase 2 sooner than anticipated and making the potentially groundbreaking cell and gene therapy available to more patients. Morula Health is delighted to have played a part in this success.