Case Study | Remote Auditing: Assessing GCP Compliance for Global Service Providers

Background and Challenges

Since remote/hybrid working was introduced and the use of computerised systems to store data electronically has become more prevalent, there has been increasing interest in remote auditing within the clinical trial industry. Remote auditing is particularly useful when working with global companies, since it keeps costs down for the client by avoiding multiple site visits and allows flexibility for the auditor to accommodate multiple time zones within one audit. Arithmos has supported several clients with a number of remote audits over recent years, particularly in the area of Good Clinical Practice (GCP), and this case study will explore one example of a remote audit that we have conducted on behalf of a client this year.

Our client, a specialist company based in the US working to develop treatments within a specific therapeutic area, requested a service provider qualification audit of a contract research organisation (CRO) which they were using to support the delivery of two active clinical trials. The CRO was a renowned global company that operated within 75 countries, with their headquarters in the US, meaning staff worked across different time zones and locations.

What are the difficulties with oversight for global companies?

When working with a global CRO, clients often struggle to maintain proper oversight. This can have a significant impact on the following areas of GCP compliance:

• Management of trial activities: Where clinical trial activities are being carried out by a global CRO team across different regions, it can be difficult for the client to maintain oversight of all activities carried out by different departments, particularly when the client is based in one region.
• Data handling: Where clinical trial data is stored within various paper or electronic formats in different countries, the client may not be aware of all regulatory requirements relating to data handling in different regions. This could lead to compliance issues with global data protection, data privacy and/or clinical trial regulations.
• Staff training compliance: Where CRO staff operate across different countries and regions, the client may not be able to maintain oversight of staff training to ensure that all staff are qualified to the same standards regardless of location. The client also may not be aware of country specific requirements for different roles, for example licenses or qualifications needed to fulfil a given role as per local legislation.

These potential gaps in oversight, if left unchecked, can have serious consequences, including:

• Protocol deviations and/or serious breaches: A lack of oversight from the client could lead to departures from the protocol and/or GCP guidelines which could have a significant impact on the safety or wellbeing of subjects and/or data integrity. When a protocol deviation and/or serious breach is noted by regulatory authorities, this could lead to financial sanctions for the client or the suspension or early termination of a clinical trial.
• Reputational damage: Where a CRO is not operating in compliance with GCP, this will reflect poorly on the client, since the client holds overall responsibility for GCP compliance for any clinical trials that they are sponsoring.

Our Approach

Arithmos allocated an experienced GCP auditor to qualify the CRO remotely on behalf of the client. The following steps were taken to ensure the audit effectively evaluated GCP compliance:

• Strategic pre-audit planning: We liaised with the CRO to ensure that interviews with subject matter experts were scheduled at appropriate times to accommodate the time zone in which each member of staff operated.
• Detailed audit agenda: We created a comprehensive agenda outlining the scope of the audit which was agreed with both the client and the CRO. The agenda included opening and closing meetings, interviews with key staff, demonstrations of relevant systems and review of selected trial and company related records.

• Use of electronic systems: Interviews with subject matter experts were conducted via Microsoft Teams, while system demonstrations were facilitated using Microsoft Teams screen sharing. The review of electronic Trial Master File (eTMF) documents was carried out by the CRO providing the auditor with access to the eTMF system. Requested documents were shared with the auditor via a dedicated SharePoint folder for review.

Success Factors and Outcome

Once the audit had been conducted, Arithmos delivered a comprehensive audit report to the client which described the systems and processes evaluated, documented how each key department was assessed and provided observations and recommendations to maintain the compliance status of the CRO. The report concluded that, with appropriate corrective and preventive actions (CAPA) implemented, the CRO would remain compliant with GCP guidelines and applicable global regulations.

The key factors contributing to this success were:

• Auditor flexibility: Our auditors are ready and willing to facilitate audits across all time zones, and have successfully conducted remote audits in several regions including UK, EU, US and Australia.
• Global expertise: Our team of auditors includes subject matter experts across all GxP areas who have experience conducting audits in the UK, EU, US, Australia, Japan, China and several other countries / regions. In terms of GCP, our GCP auditors have significant experience working with key global regulations including the UK Statutory Instruments, the EU Clinical Trial Regulation and the FDA guidelines.
• Detail oriented approach: The comprehensive audit agenda and structured interviews held with subject matter experts provided a great level of detail for the auditor to include in the final audit report. This allowed the client to understand the processes used by the CRO, and made it simple to identify any gaps or deficiencies to be addressed by corrective and preventive actions (CAPA).

Conclusion

This case study demonstrates the importance of remote auditing in maintaining GCP compliance and oversight within the clinical trial industry.

At Arithmos, we offer a comprehensive suite of GCP audit services to help companies like yours to ensure the safety of trial participants and the quality and integrity of clinical trial data. We can help you:

• Assess the GCP compliance status of a CRO, service provider or clinical site
• Identify and address potential compliance gaps in processes and/or documentation, including Quality Management System (QMS) improvement projects
• Develop and implement effective CAPAs following audits
• Prepare your organisation for successful regulatory inspections by performing internal / external audits and mock inspections
• Provide training to staff on a number of GCP topics including GCP inductions, serious breaches and sponsor oversight of clinical trials

By partnering with us, you can gain peace of mind knowing your clinical trial is facilitated in a GCP-compliant environment, reducing risks and ensuring the smooth progression of your clinical trial from the set up phase through to close out and marketing applications.

About Arithmos

With deep expertise in the Life Science Industry, Arithmos supports companies in their digital transformation journey to achieve the best value from technology-enabled solutions and excellence in business operations.

Arithmos team share extensive knowledge of the full GxP regulated environment for both deliveries of services and technologies, and our domains range from Clinical R&D, Quality Assurance, Drug Safety & Pharmacovigilance, Regulatory and Medical Affairs