The goal of MedSource’s Scientific Development unit is to help drug developers take assets from the post-discovery into the clinic and strategize pathways to accelerate the drug development to market. Unlike traditional clinical research organizations (CRO), MedSource has the expertise to deliver standalone consulting services for early clinical development or as part of our full service, end-to-end clinical trial solutions. Our team is nimble, flexible and composed of seasoned clinical scientists and subject matter experts with expertise across science, medicine, regulatory affairs, clinical development and clinical operations. By leveraging our expertise at the early development phase of your project, MedSource can help move assets smoothly, strategically and efficiently through Investigational New Drug (IND) enabling or clinical trial application (CTA) submission processes. Below are a few of our core Scientific Development services.
Medical Writing
- Protocol
- Investigator brochure (IB)
- Clinical Study Report (CSR)
Clinical Development Planning
- Indication prioritization
- Clinical development plan (CDP)
- Competitive intelligence
- Scientific rationale support
- Early drug development literature
Regulatory Authority Submissions and Preparation
- Gap analysis for IND or CTA strategic planning
- Pre-IND or other regulatory agency meeting preparation and support
- Compile/draft modules for the IND/CTA application
- Organize and submit the final IND/CTA application
