Sofpromed

Sofpromed is a full-service clinical research organization (CRO) that manages Phase I–IV clinical trials globally. The organization specializes in oncology and cardiovascular, metabolic, central nervous system, dermatological, infectious, and respiratory diseases.

Core Capabilities

Sofpromed provides comprehensive trial management services including:

• Regulatory & Ethics: Ethics committee submissions, competent authority interactions, and insurance policy management
• Site Management: Selection visits, site contracts, initiation visits, onsite monitoring, source data verification, and CRF review
• Data Management: eCRF/database design, data cleaning, and query resolution
• Safety & Pharmacovigilance: SAE/SUSAR management, EudraVigilance reporting, and safety report preparation
• Biostatistics & Analysis: Sample size determination, statistical programming, and statistical analysis
• Medical Writing & Publications: Protocol development, informed consent preparation, and publication support
• Trial Operations: Biological sample shipments, drug distribution, trial materials management, and financial oversight

Therapeutic Focus

The organization has particular expertise in rare tumor research, recognizing the unique challenges of conducting clinical trials in oncology with small patient populations and the need for international collaboration and adaptive trial designs.