Clinical Investigator Support and Site Management
- Expertise in IDE, Biologics, IND, and Outcome Studies
- Study Management
- Adherence to Good Clinical Practice
- Site Qualification
- Site Monitoring
- Protocol Development/Study Design
- Adverse Events and Safety Monitoring
- Institutional Review Board Process
- Maintaining Effective Communications with Sponsors and/or CROs, IRBs, and the Institution
- Study Closure
- Data Analysis
- Financial Services
- Clinical Trial Contract/Agreement Negotiation
- Healthcare Reimbursement
- Study Compensation
- Peer Reviewed Publications
- Study Coordination
- Subject Enrollment
- Subject Recruitment
- Adverse Event Reporting
- Subject Compensation Management
- Subject Retention
- Institutional Review Board Process Management
- Patient Compliance
- Data Collection
- Database Management
- Data Collection
- Patient Reported Outcomes
- On-site Paper-Based and/or Electronic Data Capture
- Off-Site Data Capture via Patient Web Portal or Mailed Outcome Forms
- Real-Time Quality Control