In-Vitro Studies

Our team identify contract research organizations (CROs) on behalf of sponsors for In-vitro studies of some formulation products and Bio-waiver studies.

By conducting thorough audits, we help ensure that the selected CROs have the necessary expertise, infrastructure, and commitment to regulatory standards. This process not only safeguards the interests of the sponsors but also contributes to the integrity and reliability of the research outcomes. 

Monitoring/audit of IVRT, IVPT, Binding studies, Bio-waiver studies, feeding tube studies is done considering criticality of projects. It includes:

•  Inspection track records
• SOPs/Policies review 
• Training of staff
• Resource management, Software compatibility, Excel validation  
• Method development and validation data 
• Sample analysis data 
• Calibration, IQ, OQ and PQ of instruments
• IT infrastructure and computer system validation
• Data handling and transfer 
• Archive, Data back up
• Vendor audit