Services
Medical Writing

• Provide expert medical oversight to ensure accuracy of clinical study reports, and/or reports for regulatory submissions and updates
• Write case narratives (patient narratives) for clinical study report

Training

• Provide training for Medical Data Reviewers and Clinical Research Associates
  - ICH and GCP Guidance
  - Innovative instruction to bridge the gap between data management and clinical personnel
  - Overview of the application of principles, concepts, best practices and standards of the CRO, pharmaceutical, biotechnology and medical device industries
  - Comprehensive overview of the roles and responsibilities of CRAs
  - Introduction to Clinical Data Management, proper techniques and practices for performing medical review of clinical data
  - Therapeutic area training for Data Management personnel, CRAs and Clinical Study Coordinators

Pre-Marketing Consultation

• Review of promotional and publication materials intended for the medical community or public to ensure scientific and medical accuracy