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STAR (Site Tracking and Recruitment)
Project Management
Feasibility Studies
Sites
Clinical Monitoring
Protocol Design
» Regulatory Document Management
Patient Recruitment
GCP Audits
Medical Monitoring
Investigator Contract Negotiation
Investigator Grant Management
Web Portal
Vendor Management
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Clinical Trial Management
Regulatory Document Management
The regulatory team at ACORN CRO recognizes how vital a prompt start-up is to trial initiation. Intuitive, straightforward trial start-up packages and support make an important difference in how quickly sites complete regulatory requirements. Add to that our knowledgeable, committed regulatory staff, and successful results become immediately apparent to both sponsors and participating investigators.
Rely on ACORN CRO Regulatory for: - Comprehensive trial start-up packages (containing all essential study documents, forms and templates as appropriate)
- Immediate consultation as needed
- Dedicated associate for each study
- Management of initial and updated study document submissions to the Central IRB and participating sites (protocol, consent form, investigator’s brochure, IND safety reports, patient materials, etc.)
- IND exemption requests and IND submissions to the FDA
- Status tracking throughout submission process
- Timeline tracking for IRB reapprovals to avoid lapses in IRB approval
- Collection, oversight and maintenance of regulatory documents for sponsor records
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