Quality Assurance and Audit Support

As a team of highly experienced Clinical Research Coordinators, we assuredly address all quality concerns to facilitate a smooth and swift start-up.

Several years of experience in the domain help us identify the potential challenges that may delay the start-up. Thus, with our close assistance to our clients, we ensure resolution of all sorts of anticipated issues that may come up so that the site can be started rapidly.

At Clinox, we assist you with –

Review of site facility, resources, source documentation practices, EC’s SOP etc. and up-scaling (as and where required) to meet the ICH-GCP and applicable regulatory requirements (Schedule-Y).

Identification and development of potential Principal Investigator(s) (PIs)

Assistance in the execution of Undertaking by the Investigator (Appendix-VII of Schedule-Y), Form FDA 1572, Financial Disclosure, Clinical Trial Agreement etc.

Communication with study Sponsor/CRO

Translation and validation of ICF in required vernacular language(s).