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Understanding the Roles of Operations and Quality in a CRO

Understanding the Roles of Operations and Quality in a CRO blog image.

In Clinical Research, as in most things in life, balance is key. An even balance between clinical operations and clinical quality assurance is essential to the success of any clinical trial, not just during the clinical conduct, but in all areas from proposal to Clinical Study Report (CSR). 

A CRO with a heavy operational focus may be successful at filling panels and completing projects within sponsor established timelines, but in their tunnel vision of study execution, run the risk of unintentionally overlooking some of the more obscure or rarely utilized/applicable industry regulations or guidelines. This often can result in a negative inspection or audit outcome, sometimes halting clinical operations completely until such issues can be addressed and/or corrected. 

A CRO with too much emphasis on clinical quality assurance, on the other hand, can be guilty of over complicating otherwise appropriate clinical practices to where the burden of compliance interferes with study activities, delays timelines, or causes more issues than the process was intending to avoid.

 At BioPharma Services, we realize both teams are equally important in establishing a culture of compliance that is necessary to effectively and efficiently protect subject safety and produce accurate, reliable, and high-quality data for our sponsors. Not only do these two teams need to work together toward this common goal, but they need to have balance.

Understanding the Role of Clinical Operations in a CRO

On one side of this proverbial scale, it is important to have a well versed and experienced Clinical Operations team. It is the role of the Operational team to execute all clinical trials, per protocol, collect all required data, capture all study endpoints, and effectively interface with investors, sponsors, and study participants

At BioPharma Services, our professional and knowledgeable clinical operations team has helped earn us a reputation that is recognized worldwide for being one of the industry’s top leaders in Bioequivalence and Bioavailability studies for the better part of the last 2 decades. However, while we may have started in Bioavailability/Bioequivalence, having an Operational team that is strong, yet agile, has allowed us to branch out even further over the last few years into more complex Human Abuse Liability studies, studies on Psychedelics, PET Imagining trials, and Phase 1 studies.

Moving from Bioavailability/Bioequivalence area of focus to another so seamlessly requires flexibility and a team that is excited to take on new challenges. BioPharma’s Clinical Operational team has proved itself competent and adaptable to any new processes or procedures a protocol might bring.

Understanding the Role of Clinical Quality Assurance in a CRO

On the other side of this scale, however, it is known that successful recruitment, execution of the study, providing data to our sponsors within established timelines, and within budget, is only half the battle. At the same time, and of equal importance, we must ensure the safety of our subjects and the integrity of our data. As a full-service CRO, we must be inspection and audit ready at all times. By taking on the responsibility of ensuring that the Operational team is adhering to all applicable regulations and guidelines, clinical quality assurance provides protection for all the hard work that goes into the planning and execution of each clinical trial. 

After the trial, and in the event of an audit or inspection, clinical quality assurance provides support to the Operational team by taking on the hosting responsibilities and facilitating any requests. 

BioPharma Services’ Clinical Quality Assurance team has experience with many diverse sponsors and different regulatory agencies including the US FDA, Health Canada, UK MHRA, ANSM, DKMA, ANVISA, World Health Organization, and the Standards Council of Canada. It is essential that the clinical quality assurance team is well versed in all applicable regulations and ICH GCP E6 (R2) and can serve as a resource to the Operational teams from study start up to finalization of the CSR and beyond.

Moving Past the ‘Police’ Stereotype of Clinical Quality Assurance

It is easy to misunderstand the role of clinical quality assurance. Unfortunately, the QA team can often be perceived as the “police” during drug development. While it is the responsibility of clinical quality assurance to correct non-compliance and identify opportunities for improvement, the execution of these responsibilities should not feel like the QA team is “out to get” anyone. The role of clinical quality assurance to assist the Operational team by ensuring processes and procedures are not only compliant per all applicable regulations and guidelines, but also reasonable to perform and not overly complicated. 

Clinical quality assurance must stay mindful not to impede clinical operations in their execution of a protocol, but instead to aid clinical operations in this task. It is important everyone understands both teams play an equal part in achieving the common goal of keeping subjects safe, the data clean, sponsors happy, and regulators satisfied.

The Importance of Mutual Understanding and Collaboration

Leaving the scale unbalanced can lead to negative consequences. A perfectly executed study day in the clinic can be easily overshadowed if the data captured in source documents is poorly documented, causing the integrity of the data to be questioned or even thrown out. By the same token, SOPs that are overly complicated and “paint [the clinic] into a corner” can lead to non-compliance simply because the Operational team is unable to comply with our own internal expectations.

The clinical quality assurance team has the responsibility to ensure clinical operations can “operate” within the required framework of our regulatory authorities. Clinical operations have the responsibility to be open and forth coming with clinical quality assurance in order to do so.

It is paramount that both teams understand the other’s role and respect everything being done by the other to get the CRO as a whole to the same happy outcome of pleasing our subjects and sponsors as well as our regulators.

Strategies for Building Stronger Collaboration Between Clinical Operations and Clinical Quality Assurance

Leaders of these departments will set the tone. It is important for staff to see real-life collaboration and respect for their counterparts at all stages. This includes being open to all ideas and thoughtful decision-making when the teams disagree, all the while, keeping in mind that neither the reasonable execution of a study nor the quality of the data can be sacrificed.

An Operational lead that is openly hostile to clinical quality assurance suggestions, is just as harmful as the QA Auditor that appears to shame Operational staff as opposed to help guide and educate.

Why Choose BioPharma Services?

Building a strong professional working relationship between the two teams ensures they both meet their goal of completing a successful trial. 

At BioPharma Services, we understand that the responsibility is shared by both clinical operations and clinical quality assurance to ensure that open communication remains consistent, both departments have a seat at the table, and an established healthy understanding for the role each team plays is clear. We value the collaboration between these groups and believe it has been vital to all of our many successful projects and regulatory inspections.

Written by: Holly McAfee, Director of Quality Assurance.

BioPharma Services, Inc., a Think Research Corporation and clinical trial services company, is a full-service Contract Clinical Research Organization (CRO) based in Toronto, Canada, specializing in Phase 1 clinical trials 1/2a and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma conducts clinical research operations from its Canadian facility, with access to healthy volunteers and special populations.

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