Clinical Research*
- Scientific project development
- Drafting of the study protocol
- Design, plan, and implementation of the Electronic Case Report Form (eCRF)
- Drafting of the Clinical Study Report (ICH-E3 Standard)
- Development and update of Investigator’s Brochures in accordance with the ICH-GCP standards
- Development of the Investigational Medical Product Dossier (IMPD)
- Ethical / Administrative Approvals
- Clinical trial monitoring
- Project management
- Pharmacovigilance
- Data Management
- Statistical analyses
- Centralized Laboratory
- Experimental drug trials setup
*Consulting Activities carried out by Compass with CROs and companies specialized in the field.
Medical Affairs
- Scientific support to Product Managers for the promotion and launch of medical products
- Review and analysis of scientific literature
- Development of Field-Force material, ensuring scientific accuracy and compliance with current regulations
Medical Writing
- Planning and organizing of Advisory Boards
- Drafting and reviewing articles for publication in medical journals
- Editorial Scouting
- Medical disclosure for patients and / or patient associations.
Market Access
- Development of Market Access support materials for Pricing and Reimbursement of medicinal products and the Introduction of Medicinal Specialties in the Regional Pharmaceutical Formularies