Sofpromed

Sofpromed is a full-service contract research organization (CRO) that manages phase I–IV clinical trials for biotech companies across the United States, United Kingdom, Europe, and Australia. The company handles the full spectrum of clinical trial operations, from regulatory submissions and site selection through to data management, biostatistics, pharmacovigilance, and medical writing.

Sofpromed serves clients across a range of therapeutic areas, including oncology (with specific expertise in soft tissue sarcoma and gynecological cancers), pediatric tumors, cardiovascular, metabolic, central nervous system (CNS), dermatology, infectious diseases, respiratory diseases, and pain and analgesia. The company operates offices in Moorpark, California (USA), London (UK), and Europe, with team members also based in Asia-Pacific.

Full-Service CRO Capabilities

• Regulatory affairs support for the United States and Europe, including submissions to the MHRA (UK), TGA (Australia), CTIS (Europe), and LEPL (Georgia)
• Ethics committee submissions across the UK, Australia, and multiple European countries including Spain, France, Germany, Italy, Poland, Czech Republic, Slovakia, Greece, and Georgia
• Site feasibility assessments and site selection, activation, and management across all major operating regions
• Onsite and remote monitoring, including source data verification and CRF review
• Logistics management covering biological sample shipments, drug distribution, and trial materials
• Pharmacovigilance services including SAE and SUSAR management, EudraVigilance reporting, and safety reports
• Medical writing and translation services for protocols, informed consent forms, and publications
• Project management covering planning, follow-up, quality control, and financial management

Data Management and Biostatistics

• Data management services including data management plans, data validation plans, CRF design, EDC implementation, and data cleaning
• CDISC standards implementation covering CDASH, SDTM, and ADaM
• Biostatistics services including sample size calculations, statistical analysis plans (SAP), SAS programming, statistical reports, and PK reports
• Proprietary electronic data capture (EDC) software available as part of the clinical research software offering
• GCP auditing and data protection services

FSP and Functional Outsourcing

• Functional service provider (FSP) and outsourcing model available as an alternative to full-service engagement
• Individual roles available for outsourcing include project managers, clinical research associates, research coordinators, statistical programmers, data managers, and medical monitors
• FSP cost calculator and staffing pricing tools available on the company website

CDMO Services

• Contract development and manufacturing organization (CDMO) services offered alongside CRO capabilities
• Services include formulation development, analytical testing, API manufacturing, and drug product manufacturing
• Specialized manufacturing capabilities covering aseptic fill finish, cell and gene therapy, high potency and cytotoxic compounds, and lyophilization
• Drug labeling, packaging, storage, and distribution services also available
• GMP auditing services provided

Site Networks and Community-Based Research

• Site network services available to support investigator site identification and management
• Community-based research offering to broaden patient access and trial reach
• Rater training and bioanalysis services also listed among CRO capabilities

Global Reach

• Operations and services available across the United States, United Kingdom, Europe (including Spain, France, Germany, Italy, Poland, Czech Republic, Slovakia, Greece, and Georgia), Australia, Canada, China, India, Israel, Japan, Singapore, and other regions
• Trial cost calculator available on the website to allow clients to estimate clinical trial budgets
• Pricing tools also available for data management and statistics, FSP and staffing, EDC systems, drug manufacturing, and drug labeling and packaging

Sofpromed positions itself as a partner for biotech companies seeking to conduct clinical trials across multiple geographies, offering both full-service CRO management and modular FSP or CDMO support depending on client needs.