Quality is an essential element that underpins every aspect of a clinical trial. As an industry, we easily understand the benefits of quality monitoring to ensure quality data and clinical trial management. However, we often underestimate or do not understand the broader Quality Assurance (QA) function and how a well-trained team of QA auditors can ensure successful trial outcomes.
What is monitoring, and what is auditing?
On the surface, monitoring and auditing might seem synonymous, yet these two roles serve different purposes.
Monitoring is a quality control function that routinely, and on an ongoing basis, assesses every aspect of trial conduct at the Trial Site. During a monitoring visit, the monitor will look at each individual data point in detail.
Auditing is a quality assurance function typically performed by either an in-house audit team or an independent contractor. The purpose of an audit is to provide an independent systemic examination of trial-related processes and documents, providing the trial sponsor with an objective assessment of their trial quality and compliance.
During an audit, the auditor will look at data collection procedures, review documentation, and conduct interviews with the site staff. An auditor will assess a trial site's compliance to the protocol, standard operating procedures, and regulatory standards, including the International Conference of Harmonization of Good Clinical Practice (GCP), the FDA's Code of Federal Regulations, or other national or international standards. Auditing is an essential function for trial sponsors to oversee trial conduct.
Trial Site and Vendor Pre-Qualification
The importance of selecting the right sites and the right vendors to support a clinical study at the very beginning ensures the success of your clinical trial. Trial vendors may include trial sites, CROs, laboratories, data management, and statistical providers.
During the planning phase of your clinical trial, a QA team can assess a site or vendor to ensure that there are quality management systems and standard operating procedures in place. Quality systems and processes guarantee you have the selected the best partners from the start to deliver your study.
The increased importance of Quality Assurance Audit in a pandemic
The COVID-19 pandemic has altered the way every business operates. Trial sites are closed, state and Government COVID alert level movements require agile business processes, and business continuity planning has never been more vital. Remote monitoring processes, flexible working from home, telehealth, and virtual trial capabilities have changed this industry significantly over the past year.
Pharmaceutical Solutions believes that it is important to continually review how sites and vendors cope in this new fragile environment.
"There is a need not only to qualify sites and vendors at the start of a clinical trial but also a need to consider "fitness or re-qualification reviews" to consider the impact of COVID-19 on business processes" –- Jacquie Palmer – Managing Director Pharmaceutical Solutions
An experienced, well-trained, and knowledgeable QA team can provide clients with the assurance that sites and vendors are continuing to follow best practices. Currently, with international travel restrictions, flying in auditors from overseas is no longer viable. You may not even have the in-house capability or capacity to conduct these reviews.
Pharmaceutical Solutions can help.
Remote or on-site audits?
Traditionally, auditing has been carried out on site. However, the added complications of the pandemic have forced us to rethink how we operate. Remote working has been the solution to many problems brought on by COVID-19, and clinical trial auditing is no different.
The differences between an on-site and a remote audit can be significant. Our team can guide you on the best options for your specific situation. We can audit both remotely and on-site. We are pragmatic in our approach to this. We believe that on-site is best, but we need to be flexible while ensuring quality outcomes.
“With the advent of COVID-19 globally, due to the ongoing travel restrictions, we are seeing sponsors requiring local on the ground support. They just do not have locally based audit capabilities."– Jacquie Palmer – Managing Director Pharmaceutical Solutions
Independent auditing services internationally accredited
Don't have in-house capability or capacity to conduct an audit? Has your audit function been interrupted by COVID-19 international travel restrictions? Or do you need guidance on assessing whether conducting audits on-site or remotely is most appropriate? Pharmaceutical Solutions can help.
Pharmaceutical Solutions has an Internationally Accredited, IAOCR, independently qualified team of Quality Assurance Auditors whose professionalism, competence, and experience will provide guidance and assurance in a changing world.
Reach out and leverage our expertise.
Contact jorrits@Pharmaceutical Solutions.com or call +64 9 379 8205.