Clinical Auditing Services

Clinical Quality Audits

In many domains, from finance to the aviation industry, audits as independent evaluations of activities, processes and product quality have become a routine element of quality management. This is also the case for the pharmaceutical industry and drug development, where audits of clinical trial activities have become a key part of the development process since the implementation of ICH E6 in 1997, and have become a regulatory expectation in recent years.  Audits of clinical trials are usually undertaken by an independent team of specialist auditors within a sponsor company, or they can be outsourced by the sponsor to a third party service provider.

The primary objectives of clinical quality audits are to ensure that the rights of trial subjects are respected (as per the Declaration of Helsinki) and that the integrity of the trial data can be assured. Sponsors of clinical trials are expected to implement systems with procedures that assure the quality of every aspect of the trial, and these systems are subject to regular audit.

Routine audits of clinical trials can be scheduled during any phase of development and at any time during the conduct of the trial.  It is unusual to conduct audits after a trial has completed, as it would be too late to take any corrective action to improve the quality of the trial.  Such post-trial audits usually take place in preparation for a regulatory authority inspection, but not as part of the ongoing quality improvement process.

The types of clinical quality audits that might form part of the overall audit strategy would include:

• Audits of a sample of investigator sites participating in a specific clinical trial:  These audits allow site-specific problems to be identified and corrected, but also highlight systematic issues that can impact on the quality of the trial as a whole.  Prompt corrective and preventative actions by the responsible clinical study teams can significantly improve the overall quality of the trial
• Audits of third party service providers:  Sponsor organisations frequently outsource clinical trial activities as they might not have the necessary resource or expertise internally.  The sponsor is ultimately responsible for the quality of the clinical trial, and therefore has to ensure that its service providers produce deliverables of the required standard.  Sponsors therefore conduct independent audits of service providers at regular intervals to ensure that their systems continue to meet the necessary regulatory standards
• Audits of specific systems:  Systems audits may be conducted to assess whether a particular activity is in compliance with regulations.  For example, the procedures for data management and statistical analysis might be reviewed in detail, and process improvements identified.  Systems audits involve a review of the standard operating procedures in use, interviews of personnel implementing the procedures and a review of sample data to assess whether the procedures are effective and being complied with

Following the conduct of an audit, a detailed audit report is written with all of the observations made during the audit.  The auditees are then required to develop a corrective and preventative action plan (CAPA), with timelines and responsibilities allocated.  The completion of the CAPA may be tracked by the auditor, but the responsibility for implementation of the actions is the auditee’s.  Audits are a snap-shot in time, and should contribute to the overall quality improvement process. They are not usually requested by regulatory inspectors, but evidence that planned audits have been conducted may be required.

The conduct of clinical quality audits is becoming an increasingly challenging process owing to the complexity of clinical trials and the location of investigator sites.  Although the majority of sponsor organisations reside in Europe, the USA and Japan, their clinical trial sites are often located in Asia, Africa, South America, the Middle East and Far East.  Not only are auditors challenged with physically reaching the investigator sites, but they also have to deal with the diverse cultures they encounter.  ADAMAS is fortunate in having a global reach with alliance partners based in many of these regions.  Not only does this help with language and cultural barriers, but also the travel time and cost for the conduct of these audits.

We have a highly experienced, trained and competent team of clinical auditors available on a worldwide basis.