All the services you expect from a clinical trial
Providing services to CRO, Sponsors, Hospitals and Clinicians to facilitate the clinical trials. Also helps hospitals to set up the Clinical Research Department.
clinical research coordinator
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.
PI and Site selection
KVCR has associates with 32 Hospital across India(including govt and private Hospital).
KVCR facilitates the submission and approval of trial specific 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.
ICH-GCP and Regulatory Training
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.
Clinical Operation Services
- Study start-up including potential sites and experienced P suggestions.
- Study documents submission to Ethics committee.
- Feasibility of studies and initial documents preparation at site level
- Subject recruitment & follow-up.
Clinical Data Management
We offer fast turnaround and a flexible, efficient process for any project, including:
- Data entry in paper CRF or eCRF
- Data submission on fast-track process to CRO/Sponsor
- 24/7 available for SMO services
- Document archival facility as per regulatory guidelines
Manpower Management Services
We provide following trained manpower:
- Clinical Research Coordinators
- Conducts annual and proper training for Research
- Professionals including investigators
Ethical Committee related Services
- SOP preparation IEC, DHR and DCGI registration
- SUGAM Portal Registration
- IEC Re-registration
- NAITIK Portal Registration
- NABH Accreditation for IEC
- ICH-GCP training programs for IEC Members
- DHR (EC) Registration.
Visit us at our headquarters for a free consulting hour.