IND Modification for Phase I Clinical Trial

IND Clinical Trial Technical Writing in preparation of FDA submission

Area: Greater Seattle Area
Project Type: Regulatory Affairs, Technical Writing

About this Project

OBJECTIVE

Client received FDA responses to initial Phase I Clinical Trial submission. Client required support in ensuring documents were modified and complete for FDA submission.

SERVICES

PSC® supported a small, start-up biopharmaceutical company with their Investigational New Drug (IND) application. With commentary from the FDA and a short time-line, PSC provided updates and modifications to the IND Phase I Clinical Trial Submission to ensure FDA approval. PSC® also provided Strategies for Optimization of Design of Forms to set the client up for success for future submissions.

PROJECT SUCCESS

PSC® has successfully completed the IND Modification for Phase I Clinical Trial within scope, schedule, and budget, and received outstanding feedback from the client’s Executive Team.