Services
We work with International Companies (Sponsors) in identifying and conducting due diligence on Indian CROs (early stage and established). For the domestic clients, we are the leaders in providing support services in the areas of systems development, documentation, data management consulting, liaisoning and internal audits. We also conduct a six month training program for professionals who want to join the clinical trials industry.
Services
Audit of investigative site operations to determine adequacy of documentation and procedures, and to ensure your trial will be carried out in a controlled manner, per protocol, and in compliance with regulations. Our team has expertise in auditing multiple sites and BA/BE facilities across India
Audit of Institutional Review Board operations and documentation for compliance with Protection of Human Subjects and Institutional Review Board regulations (21 CFR 50 and 56).
We can develop and deliver a complete auditing solution for you by implementing our Outsource QA program. Outsource QA allows you to maintain quality at your site, leveraging our QA team and systems, reducing total cost of ownership
We work with a variety of clients in bringing in expertise on a “need-basis”. We have worked with early stage CROs in building up their systems and teams. We have also worked with large established CROs in reviewing and assisting in documentation development.
We provide a comprehensive Computer Systems Validation (CSV) audit service in all stages of the life cycle of a computerised system. The objective of the CSV audit is to assess good computer system management practice, and to verify that the computerised system is validated according to regulatory requirements such as 21 CFR part 11.
We have the experience, the skills and the competencies to conduct independent due diligence of a clinical research organisations (CRO) to help Venture Capital firms and Investors understand and manage the associated risks.