Clinical Trial Management Services
Clinical Trial Start-up
Centralization of Clinical Trial Start-up - Our centralized approach to study start-up, regulatory documentation collection and regulatory package and submission helps to accelerate the study initiation timeline.
Our services include:
- Identifying multiple affiliated physicians for study consideration
- Qualifying study sites and help find appropriate trials
- Negotiating contracts and budgets on behalf of sites
- Preparing regulatory packets on behalf of sites
- Arranging and attending site qualification/initiation visits
Clinical Operations
CRI International can provide clinical expertise as a vital contact point to facilitate sponsor and site interaction. These highly skilled, experienced research liaisons will help manage the clinical trial from site approval to closeout. Also, these research liaisons will:
- Ensure appropriate set-up for conducting trials
- Prepare source documents, regulatory submissions and subject folders for each study
- Monitor and suggest patient recruitment campaigns
- Interface with sponsor monitors
- Assist with audit preparedness and readiness
- Provide general troubleshooting
- Oversee Clinical Research Coordinators (CRC’s)
Information Technology
As part of a controlled flow of information, CRI International uses proprietary software to help study sites more effectively manage the clinical and business elements of all clinical trials.
This system consists of:
- Patient visit tracking system
- Project cost tracking
- Patient database
- Financial Management
- Overall study management
Investigators Services
CRI International links sponsors with highly focused investigators. Beyond required adherence to protocol, we work with sites according to specific study expectations, including therapeutic experience, geographic location, office environment and patient mix.
Comprehensive Business Growth Opportunities
- Marketing the site to pharmaceutical companies and CRO to secure a steady flow of studies
- Completing regulatory documentation IRB submission and maintenance of approvals
- Providing Quality Assurance Monitoring
- Representing the site in the event of sponsor or FDA audit
- Negotiating contracts and budgets
- Maintaining file storage
- Preparing source documents for each study
- Attending site qualification visits with the sponsor and site
- Assigning one central point of contact through the project manager
- Preparing patient recruitment plan at study at initiation