Considering the long experience of Sponsor’s audits and Regulatory audits, our company can provide a wide range of services related to clinical audits and quality assurance taking into account the specifics of the Ukrainian local legislation
We provide Internal Investigator Site Audits for the research center at any stage of the clinical trial:
the assessment audit (at the planning stage of the clinical trial);
the audits during the clinical trial (for compliance with the protocol and ICH GCP requirements);
the archived materials (after the finish of clinical trial).
We also prepare the research center for any type of audits.