Our teams are composed of highly skilled independent consultants with decades of experience in the areas of clinical research and/or medical safety, and/or medical writing.
We have knowledge and expertise in the following areas:
Medical Writing
· Clinical Evaluation Report (CER · Risk:Benefit Reports · Investigator Brochure · Scientific Abstracts/Posters
Manuscripts
Clinical Research
· Global Clinical Trial Strategic Planning and Management
· Clinical Strategy, Study Design, Protocol Development
· Study Monitoring
· Site Management
· GCP Audits
· Clinical Reports
· Publication Strategies
Medical Safety/Vigilance
· Medical Monitoring
· AE/SAE-Medical Case Reviews/Assessments
· AE/Safety Narrative Writing
· Periodic Safety Reports
· CEC and DMC Mgt.
· Product Complaint Handling-Reviews/Assessment
· Medical Device Reporting (MDR)