Resource was needed to support the annual investigator’s brochure (IB) update for a drug-development program. No in-house resource was available to manage a long-term program of work for a drug in development.
A senior writer was assigned to represent medical writing. This writer was the project lead and liaised with the team, identified the areas requiring update, and proactively managed the contributions from team members. Continued support was provided for further CSRs, orphan drug designation applications for various indications in the EU and US, further IB updates, pediatric plans, risk management plans, and submission documentation.
As a result of the relationship built during the project, the same project lead has supported the annual IB update for several years, providing continuity for the client. The lead writer works with other Complete Regulatory team members, as needed, to manage the high workload, document review, and quality control.