Medsource
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Contents
[hide]Taking Relationships as Seriously as Science[edit | edit source]
MedSource is an award-winning clinical research organization (CRO) that delivers high-quality clinical trials through strong relationships and specializes in oncology, neurology and infectious diseases. We have participated in almost 700 clinical trials globally; more than 200 of them have been in oncology. Our efforts support biopharmaceutical clients who conduct complex clinical trials in the most challenging disease states and patient populations. Our wide experience encompasses a range of therapeutic areas, product types, clinical trial phases and study designs.
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| | |
| Medsource | |
|---|---|
| Type | Private |
| Industry | Pharmaceuticals |
| Founded | 1997 |
| Headquarters | 16902 El Camino Real Suite 1A Houston, TX 77058 United States |
| Number of employees | 51-200 |
Services[edit | edit source]
Study startup[edit | edit source]
- 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[edit | edit source]
- Overall study management
- Budget and timeline tracking
- Customized weekly, monthly, and quarterly reporting
- Vendor management
Clinical trial monitoring[edit | edit source]
- Site initiation, interim monitoring and closeout visits
- Clinical research assistant (CRA) oversight
- Site management
- Query resolution
- Clinical site coordinator support
Regulatory affairs management[edit | edit source]
- 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[edit | edit source]
- 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[edit | edit source]
- Pharmacovigilance
- Medical monitoring
- Data Safety Monitoring Board (DSMB)
- Comprehensive case management
Clinical support services[edit | edit source]
- Central lab, imaging and histology vendor management
- Drug and trial supply management
- Clinical technology solutions
- Global trial management
