The services we provide include but are not limited to:
Monitoring & Participant Protection
Credibly brand standards compliant users without extensible services.
Laboratory & Clinical Audits
Credibly brand standards compliant users without extensible services.
Data Management & Training
Credibly brand standards compliant users without extensible services.
Monitoring & Participant Protection
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- Phase I-IV clinical trial monitoring
- Site Selection
- Budget Negotiation
- Ethics/Regulatory submissions and follow up
- Site Assessment
- Interim Site Monitoring
- Site Close Out
- Meticulous On-site Monitoring
- Comprehensive Off-site Monitoring
- Risk-based monitoring
- SAE/AE monitoring
Laboratory & Clinical Audits
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- Study Samples
- Investigational Products
- Investigational Devices and equipment
- On-site & Remote Trial Master File Compilation
- Site Audits and Inspections
- Management of Deviations
- Preparation of Study Manuals
Data Management & Training
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- Data entry
- CRF review
- Query Management
- Source Data Verification
- ICH-GCP E6
- GCP
- Study Protocol
- Study Manuals