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Pre-Study
| 1) | Principal Investigator selection (study specific site selection) |
| 2) | Clinical Program referral |
| 3) | IRB submission |
| 4) | Budget preparation and negotiation |
| 5) | Site selection visit preparation |
| 6) | SOP’s for Investigators |
| 7) | Contract research staff |
| 8) | Staff education on research protocols |
| 9) | Source document templates |
| 10) | Centralized communication |
Study Conduct
| 1) | Site Initiation visit |
| 2) | Monthly review of CRF and documents, between monitor visits |
| 3) | Quality Assurance |
| 4) | Attendance at monitor visits, documentation and follow up of queries |
| 5) | Ensure that each project meets regulatory guidelines |
| 6) | Provide staff training |
| 7) | Data Management |
| 8) | Monitoring |
Post Study
| 1) | Study close out |
| 2) | Query resolution |
| 3) | Study material storage |
| 4) | Site follow up |
Other
| 1) | IRB management |
| 2) | Consulting services |
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