Our extensive database of Principal Investigators, leading hospitals, and research centers allows us to access special populations to fulfill protocol requirements and ensure rapid recruitment of eligible study subjects.
Our SOPs meet the highest standards for conducting clinical trials. We manage our sites with highly qualified personnel, experienced in conducting clinical trials while adhering to applicable regulations & guideline. This includes ICH E6, schedule Y (Indian Drugs and Cosmetics Act 1945) and U. S. FDA 21 CFR parts 11, 50, 54, 56, 312 & 314.
Measurement of compliance to delivery commitments made; turn-around time of feasibility requests, documentation requests at start-up and data at study conduct time. Measurement of quality output, build metrics around variability between promised during feasibility and actually delivered, data queries per patient per study, how are these trends measured, how many monitoring follow-up action items were sent to the site, how many queries were resolved and unresolved after 15 days, 30 days, 3 months and has a regular QA been done of the studies.
KVCR has association with many Hospitals and Investigators in all super specialties, and all sites are comprised with IRB/EC committee. We have Experienced and ICH-GCP Trained Principle Investigators.
KVCR facilitates the submission and approval of trialspecific documents as per the required format from IRB/EC. This includes centralized tracking of the IRB/EC meeting schedule, requirements of each IRB/EC in terms of documents/formats and number of copies, covering letters etc. We ensure timely submission, presentation and tracking of approvals/letters, quality checking for the approvals/ letters as per the local regulatory requirement. During the conducted study, the central analytics team of KVCR assists the sites in terms of notification of SAEs/SUSARs and annual status reports to the IRB/EC or the regulatory authorities as required. This reduces the effort for the sponsors/CROs and also the site as this is centrally managed across the network of KVCR.
KVCR provides ICH-GCP, ICMR, Schedule Y, National and International guidelines Training for PIs, Co-PIs, CRCs, Nurses etc.
KVCR Infrastructure to be provided tosponsors and the investigators, are physical infrastructure (in terms of project room, storage etc), ethical infrastructure (regular committee meetings, reviews etc) and resources (Co PIs, CRCs, study nurses, raters etc.).Processes and metrics to measure through, put in clinical trials, number of studies, number of patients per study who have benefitted from trials, metrics to show running and completed projects with us, processes and metrics which has put in place to meet the target for the future.
- Arthur Conan Doyle