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- Strategic Planning - Comprehensive Clinical Investigational
Plans
- Clinical Protocol Development (phase 1, 2, 3, and 4)
- Informed Consent Forms
- Investigator Selection, Qualification, Training
- Recruitment Strategies
- Pre-IND meetings with the FDA
- Developing Data Collection Tools - Case Report Forms and
Customized Database
- Real Time Data Collection and Analysis
- Study Operations Manual
- Assisting in obtaining IRB Approval
- Initiation of Studies
- Enrolling and Randomizing Subjects (24 hours-a-day, 7
days-a-week)
- Monitoring Studies
- Coordination of Drug Shipment
- GCP Compliance Audits
- GLP Audits of Clinical Laboratories
- Quality Assurance of Data/Sites/Laboratory Results
- Serious Adverse Events Reporting
- Investigators Contracts and Enrollment Funds Payment Management
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