Insight's Medical Affair team consists of Ph.D. trained scientific writers, physicians, and safety experts. Our world-class medical subject matter experts have extensive experience developing clinical protocols, safety management plans, preparation of clinical study reports for successful regularity submissions. Our Medical Affairs team is fully integrated with our data analytics and clinical trial team across all clinical phases and highly responsive to the client's needs. Our final products go through rigorous quality assurance and scientific reviews to meet the reporting and publication requirements prior to delivery to our clients.

We specialize in the following services:

• Phase I-IV Protocol Development
• Phase I-IV Clinical Statistics Reports
• Phase I-IV Clinical Study Reports
• Investigator Brochure
• Medical Monitoring Plans
• Safety Management Plans
• Safety Reporting Processes
• Pediatric Study Plans
• Study Procedure Manuals
• Standard Operating Procedures
• Patient Narratives
• Common Technical Document (Module 1-5)
• Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategy (REMS)
• Clinical and Performance Evaluation Reports and Plans (Medical Device)
• Literature Review, Meta-Analysis
• Scientific Publications & Conference Abstracts
• Conference Submission (Abstracts, Scientific Posters, Slide decks)
• Publication Management
• Editorial Support