Clinical Project Management
Feasibility, Site Selection & Qualification, Patient Recruitment, Monitoring Services, Contract & Budget Management
Medical Writing
Clinical Study protocol, Informed Consent, Investigator Brochure, Clinical Study Report, Clinical Study Plans, Imaging Manuals
Regulatory Support
Submission to Competent Authorities and/or Ethics Committee, including CTIS applications
Medical Services
Medical Monitoring, Data Safety Monitoring Board, Safety Review Committee
