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
  • Trial master file (TMF) management
  • Site regulatory document collection and management

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Project Management

  • Global study management
  • Budget and timeline tracking
  • Customized weekly, monthly, and quarterly reporting
  • Vendor management

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Clinical Trial Monitoring

  • Site initiation, interim monitoring and closeout visits
  • Clinical research assistant (CRA) oversight
  • Site management
  • Query resolution
  • Clinical site coordinator support

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Scientific Development

  • Medical writing
  • Clinical development planning
  • Regulatory authority applications and submissions

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Data Management

  • Case report form (CRF)/eCRF design
  • Database design and build
  • Electronic data capture (EDC) and Interactive Web Response System (IWRS)
  • CDISC CDASH forms and STDM data sets
  • Medical coding

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Biostatistics

  • Sample size and power calculations
  • Study randomization schemes
  • Fixed statistical design and adaptive statistical design
  • CDISC SDTM and ADaM dataset production
  • Statistical analysis and reporting

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Pharmacovigilance

  • SAEs case management from receipt to reporting
  • Medical review by a physician including causality, expectedness, regulatory recommendation, and analysis of similar events
  • Safety database solutions
  • Expedited reporting
  • Safety Management Plans
  • Safety & clinical database reconciliation

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Medical Affairs

  • Investigator & site interactions including subject eligibility, inclusion/exclusion criteria, and medical concerns
  • Continuous medical monitoring coverage 24/7 for emergencies, weekend & holiday coverage
  • Safety Reviews for safety trends/signals, SAE reporting
  • Coding reviews for accuracy and consistency
  • Medical consulting including study designs, protocol/IB reviews, regulatory authority interactions, final study reports

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Clinical Support Services

  • Core Labs: Central lab, imaging and pathology management
  • Drug and trial supply management
  • Clinical technology solutions

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