Our clinical research associates (CRAs) conduct site initiation, routine monitoring and close-out visits using risk-based approaches aligned with ICH E6(R3). Monitoring focuses on what matters most: participant safety and critical data.
Independent quality assurance
Our QA team runs site audits, process audits and mock inspections, and helps sites implement effective corrective and preventive actions (CAPA).
What is included
- Site initiation, monitoring and close-out visits
- Risk-based and centralised monitoring
- Source data verification and review
- Protocol deviation management
- Site and vendor audits
- Mock regulatory inspections
Frequently asked questions
How quickly can you deliver feasibility?
We usually deliver a site-by-site feasibility assessment with realistic enrollment projections within five to seven business days of receiving a protocol synopsis under NDA.
Do you support medical device investigations?
Yes. We support pilot, pivotal and post-market clinical investigations of medical devices and in-vitro diagnostics in line with the Medical Devices Rules, 2017.
Can you work with overseas sponsors and CROs?
Absolutely. We regularly act as the local execution partner for international sponsors and CROs, supporting regulatory submissions, site management and monitoring in India.
What does your quality system look like?
We operate under a documented quality management system with SOPs, training records, internal audits, CAPA management and regular mock inspections at sites.