The successful completion of a project depends upon clinical investigation, which is based on better execution with ongoing support and regular communication between all parties. Since our commitment is the successful completion with quality standard of every study in which we participate, an internal staff is assigned to each study for internal monitoring and auditing to maintain quality standards for every study at study site & ensure that communication is maintained and that the study receives full attention it deserves until completion.We takes the responsibility of ensuring that the study mile stones are achieved with respect to:
• Patient enrollment and patient retention.
• Assists the Investigator in screening of patients for the study. As retention of the patients is most critical aspect in any trial, we understands the need to meet enrollment target with negligible lost to follow-up.
• ICH-GCP, Schedule-Y, Local Regulatory Authority, and Protocol Adherence.
• Site Documentation: We ensure that the site maintains proper source documentation and lab reports.
• Coordinate and manage lab samples to be sent to central labs.
• Proper reporting of AE/SAE's to Sponsor and Local Ethics Committees.
• Resolve DCF (Data Clarification Forms).
• Ensures that the site team is well prepared for the site monitoring or site audits.
• IP Accountability: We ensure investigational product accountability, dispensing and logistics to ensure that the IP is maintained at the required temperature.
1
2
3
4
5
6
7
8
