Focused Clinical Research Services

At MedSource, we provide our clients with flexible clinical research services, project-specific experience and integrated senior management. Our highly experienced team excels at delivering high-quality clinical trials, and our participation in almost 700 clinical studies has earned the confidence of the pharmaceutical and biotechnical industries. Whether a challenging therapeutic area or a sophisticated trial design, our highly experienced team provides focused solutions to meet the needs of our clients. By focusing on our core service offerings, we exceed expectations and always deliver quality results. That’s why we’re considered one of the leading clinical research organizations (CRO) in the country.

Study startup
  • 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 closeout visits
  • Clinical research assistant (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) management
  • Strategic regulatory guidance and FDA representation
  • Tactical regulatory support
Clinical data management and biostatistics
  • Trial design and sample size calculation
  • Case report form (CRF)/eCRF design
  • Electronic data capture (EDC) management
  • Statistical analysis and programming
  • Randomization and Interactive Web Response System (IWRS)
  • Medical writing
Safety
  • Pharmacovigilance
  • Medical monitoring
  • Data Safety Monitoring Board (DSMB)
  • Comprehensive case management
Clinical support services
  • Central lab, imaging and histology vendor management
  • Drug and trial supply management
  • Clinical technology solutions
  • Global trial management