Trending to a new norm: From on-site to Remote management and monitoring.
Clinear Research has already some years experience in remote management and monitoring and has implemented the standard of procedures for remote Site management. It proposes central Monitoring and study management from Mauritius, with:
- 100% SDV reviewed remotely by our in-house CRA within clients’ office hours.
- Creation, management, updating and Quality check of TMF.
- Submission to RA/EC.
- Creation and review of remote study management tools and logs to have an oversight on the on-site study progress.
- Remote training of the site staffs.
- Telemedicine by registered Physicians.
- Adaptability and Flexibility to Client’s Needs.
The key benefits of centralized monitoring:
- Helps in early identification and mitigation of data quality risk/issue(s) which may compromise validity of study results
- Supports in better monitoring of patient safety and helps in enhancing subject protection
- Increases effectiveness of CRAs and helps utilization of their time very efficiently and objectively during on-site monitoring
- Keeps track of sites’ performances to help plan on-site monitoring visits
- Optimizes on-site monitoring visits, thereby reducing related costs
- Creates overall efficiencies in clinical trial operations
- Improved recruitment.
- Reduced time for submission
- Mitigate study and site risk with secure, remote monitoring of critical documents to help keep your trials running smoothly. Assist sites and monitors in secure document acquisition, task workflow automation, and Source Document Review (SDR), saving time and costs while ensuring compliance and quality.