Auditing provides an independent assessment of the trial conduct and evaluates compliance with the protocol, SOPs, international GCP guidelines and regulations and applicable regulatory requirements. Failure to comply with the stringent standards puts at risk the acceptance of the clinical data to regulatory authorities and, hence, may jeopardize product registration. Audits focus on the verification of the safety of the trial subjects, the transparency of conduct and the validity of the trial data.
In addition to the "standard" audits in clinical research, systems audits and GCP Mock Inspections are our speciality.
Our auditors have many years of professional experience in clinical research, GCP and QA and are experts in ICH GCP, FDA, European GCP and country-specific requirements.
We offer the following audit services:
 | Protocol Audits |
| CRF Audits |
| Trial Master File / Essential Document Audits |
| Investigator Site Audits |
| Database Audits |
| Trial Report Audits |
| Common Technical Document (CTD) Audits |
| Systems Audits for key processes in clinical R & D (e.g. Phase 1 unit, monitoring, data management, biostatistics, safety reporting, investigational medicinal products etc.) |
| Pharmacovigilance Audits |
| CRO / Service Provider Audits (pre-contractual, in-process and retrospective) |
| GCP Mock Inspections |
| Due Diligence Audits |