The clinical portion of product development is not only the most time consuming, but also the most expensive. The goal of every one of our domestic and global audits is to proactively identify any potential risk or non-compliance that could interfere with the development of your product, whether related to subject protection, or product safety and efficacy.
Audits of Investigator sites allow site-specific issues to be identified and corrected, but also emphasize potentially global and/or systematic issues that can impact the quality of the trial as a whole. Prompt Corrective and Preventative Action (CAPA) taken by the Investigator and the applicable clinical teams can significantly improve the overall quality of the trial.
Once the Investigator site has been selected for an audit, we will contact the site and schedule the audit, followed by sending a confirmation letter and agenda to the site.
The following tasks will be conducted during an Investigator site audit:
We can also prepare Investigator sites for Regulatory Inspection readiness.
The majority of Clinical Investigator site audits are conducted on a routine basis, but we are also vastly experienced in investigating fraud and scientific misconduct, or ‘For Cause’ audits. We collect and document objective evidence, while maintaining a discreet and diplomatic presence. We have worked with the FDA Office of Criminal Investigations, as well as the Federal Bureau of Investigation (FBI) and the US Attorney General.
In addition to all Clinical Investigator site audit activities, we will assess the following services that are unique to Early Phase development:
Sponsors should understand the importance of vendor qualification, post-capability and maintenance review. Most sponsors will routinely conduct maintenance audits on a 2- to 3-year frequency.
The following tasks will be conducted during a CRO audit:
Sponsors/CROs frequently outsource clinical trial activities that are their responsibility, as they might not have adequate internal resources or expertise. The sponsor is ultimately responsible for the quality of the clinical trial, so must ensure that its vendors are providing quality deliverables according to the required standards. Sponsors should conduct independent audits of vendors at regular intervals to ensure that their systems continue to meet the necessary regulatory standards. Activities conducted during a vendor audit will include all those listed in the CRO audit, as applicable.
Vendors may include:
Whether the audit is conducted at an internal sponsor PVG department or a contracted vendor facility, activities conducted during a Pharmacovigilance audit will include all those listed in the CRO audits section, as applicable. We will also review individual safety case files to assess and track reportability and timelines, according to regulatory requirements.
Commercial, academic, private and hospital IRBs and ECs should be audited in accordance with FDA/OHRP regulations and other local regulations and guidelines. Central IRBs that are contracted by the Sponsor increase the risk and responsibility of the sponsor.
Sponsors should audit all aspects of clinical trial supplies to demonstrate their control and oversight, in accordance with FDA/EMA/MHRA, GMP, GCP and ICH regulations/ guidelines. In addition to a routine vendor audit, the Depot audit will include tracking of shipments through receipt and return/destruction.
All companies are wise to prepare themselves for GCP, GLP and Pharmacovigilance inspections, rather than going in ‘blind’. Achieve Quality has the skills and the experience to conduct Mock GCP, GLP and Pharmacovigilance Inspections, according to the applicable regulatory standards and your specific needs.
The following tasks will be conducted during a mock regulatory inspection:
We can also assist with hosting the Regulatory Inspection, including your response to the Agency.
System audits can be conducted to assess whether a particular activity is in compliance with regulations. For example, the Pharmacovigilance process might be reviewed in detail across all involved departments (Clinical, PVG and Regulatory Affairs), with deficiencies and process improvements identified. System audits include a review of the SOPs in use, interviews with personnel implementing the procedures, and a review of sample data to assess your staff’s compliance and whether the procedures are effective.