Case Study: Product Launch Readiness for Advanced Cell Therapy
Medical Content Development
The Situation
A biotechnology company specializing in high-science, precisely targeted, T-cell technology, was in the process of preparing for its first product launch.
The client lacked a dedicated Medical Information department and required expertise in Medical Information best practices and content development.
The Client partnered with EVERSANA to plan for, develop, and deliver high-quality and scientifically accurate Medical Information documents to be utilized in response to unsolicited requests from healthcare professionals.
The Solution
EVERSANA established weekly core-team meetings to provide overview of ongoing projects, discuss potential new projects, and maintain open lines of communication.
The team also established weekly 1:1 meetings with Client Point-of-Contact (POC) for detailed discussions regarding Medical Information deliverables, including cover letters, scientific response documents [SRD], and FAQs.
EVERSANA led the development of a product launch project plan and collaborated with the client on
prioritization and completion timelines.
EVERSANA team streamlined the review and approval processes of MI documents, utilizing the client’s Veeva
Vault platform.
The Results
Proactive, pragmatic and streamlined approach led to approval of all 22 MI documents through the MLR
process.
All documents were prepped and ready in Veeva Vault prior to PDUFA and awaited final USPI for MLR approval.
FDA approval was received 1 week early, and all documents were approved on or prior to the project plan timelines.
The client was ready and prepared for their first product launch. Client’s Medical teams and EVERSANA MI contact center were prepared to respond to unsolicited requests in an aligned, scientifically accurate, clear, and concise manner.
