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Focused Clinical Services

MedSource is a leading full-service CRO with consistent service delivery, project-specific therapeutic experience, and involved senior management. Through offices in North America and affiliates in South America, we have earned the confidence of the pharmaceutical and biotechnical industries by participating in more than 700 clinical studies.

MedSource provides support for oncology and other complex clinical trials. Whether a challenging therapeutic area or a sophisticated trial design, our highly experienced team excels at delivering results. By focusing on our core service offerings, we exceed expectations and always deliver quality.

Study Start-Up
  • Feasibility analysis and report
  • Site identification, recruitment, and qualification
  • Site contracts and investigator payments
  • Investigator meeting planning
  • Site regulatory document collection and management
Project Management
  • Overall study management
  • Budget and timeline tracking
  • Customized weekly, monthly, and quarterly reporting
  • Vendor management
Clinical Trial Monitoring
  • Site initiation, interim monitoring, and close-out visits
  • CRA oversight
  • Site management
  • Query resolution
  • Clinical site coordinator support
Regulatory Affairs Management
  • Regulatory applications and submissions
  • Clinical quality assurance audits
  • Trial master file (TMF) and electronic management
  • Strategic regulatory guidance and FDA representation
  • Tactical regulatory support
Clinical Data Management and Biostatistics
  • Trial design and sample size calculation
  • CRF/eCRF design and EDC management
  • Statistical analysis and programming
  • Randomization and IWRS
  • Medical writing
  • Pharmacovigilance
  • Medical monitoring
  • Data Safety Monitoring Boards (DSMB)
  • Comprehensive case management