RS Serve offers GCP auditing and consultancy services including:
- Study/Trial Master Files audits
- Study documents (Protocol, Informed Consent, Clinical Study Reports) audits
- Clinical Investigative Sites audits
- Clinical Databases audits
- Statistical Programming (Tables, Figures/Graphs and Listings) audits
- Pharmacovigilance audits
- Third party vendors audits (including Clinical laboratories, CROs, Drug depots, Phase I Units, Bioequivalence/Bioavailability Units (including Bio-analytical labs), Translators and Ethics Committees)
- For cause situations (including root cause analysis and Corrective and Preventive actions (CAPA) program)
Process audits
- Management of audit programs
Global reach : Experienced in conducting GCP audits in India, Australia, Japan, Malaysia, Philippines, Singapore, South Africa, South Korea, Thailand and Vietnam.
