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International Clinical Trials

Action Packed

According to analyst firm Research and Markets, a clinical trial management system (CTMS) has been said to “play a fundamental role in the modern and ever-evolving clinical development process”. It also reported that the CTMS market is expected to grow 13.5% by 2018. But do these systems go far enough to ensure quality throughout all aspects of a clinical trial? Is there a better methodology to effectively manage trials?

The answer may be hiding in plain sight in a company’s quality and compliance department. Adding quality methodology to a CTMS can create a new paradigm, one that may help it embed risk mitigation as well as efficiencies to ensure data integrity. This new model could be called a clinical quality management system (CQMS).

Big Picture

Quality and compliance operations have evolved into a strategic resource in companies which understand that, when done correctly, they can accelerate product development and approval processes, save operational costs and mitigate and manage risk. The core aspects of quality – including training, document management, risk mitigation and quality management – can be used to provide efficiencies and improve quality of data throughout the clinical trial process. Quality assurance, quality control and risk management are not simply for manufacturing.

Such operations can look at the big picture, not just at managing the electronic data that is captured at the clinical site. Quality management also involves evaluating things from a different angle. For example, steps are developed to enable potential problems to be discovered quickly and corrective actions promptly put in place to prevent a reoccurrence. In addition, protocols and standard operating procedures (SOPs) are established to help determine if a deviation or error is a one-off or could happen at other sites.

Systems and Training

When incorporating a CQMS into clinical trials, a good starting point is to examine a day in the lives of clinical operations and quality, and all the different types of systems that those groups use. For instance, how often do they use a document management system for SOPs, instructions and related study documents? Clinical quality and clinical operations often house documents and other critical data in separate systems, but this 'silo-ing' of data is not only unnecessary, but hinders efficiency. The ability to crossreference instructive documents such as SOPs on monitoring to operational documents like a monitoring report ensures that information critical to day-to-day tasks is easily and quickly accessible.

Clinical studies can also benefit from the training methodology of quality management. Of course, everyone involved in a trial needs to be trained on their roles and responsibilities – however, how well-versed are they on SOPs designed to address areas of risk and on management of deviations? Access to critical documentation often means the difference between knowledgeable informed actions and reactive inefficient actions.

Incorporating CAPA

Throughout clinical operations, many clinical professional – for example, study managers, clinical research associates (CRAs) and monitors – are already implementing quality best practices, but they often do not realise it. They may simply look at their procedures as reactive and may have developed standardised steps for responding to quality events such as a protocol deviation.

A quality management system supports documented blueprints for the step-by-step approach to be executed to ensure in-depth analysis of the issues, identifying the root cause, formulating a corrective action (CA), verifying the effectiveness of the CA, and evaluating if and when a preventative action (PA) may be deemed necessary to reduce further incidents. These steps are the core methodology of a quality management system for deviation management and corrective and preventive actions – referred to as CAPA in manufacturing. The term 'clinical CAPA' is new to many, however the methodology is not.

One of the primary ways to incorporate quality practices in clinical trials is to implement this CAPA system. It has proved a cornerstone for quality operations which can mitigate risk and ensure success. Utilising it within the trial process will help study managers deal with exceptions effectively.

Many companies might take the view that they already have suitable quality systems, but this should be scrutinised. Consider the following scenario. Someone at a clinical site mistakenly leaves a package of investigational product, which requires refrigeration, on a sunny windowsill. Once this deviation is discovered, is there a protocol or SOP in place that outlines what steps should be taken and by whom? Are there measures in place to identify the root cause of this incident? Was this a one-time, random occurrence? Was the improperly stored product administered to patients? What patient safety risks are there, and how do we monitor the patients that may have been exposed? Were the site personnel adequately trained regarding proper product storage? If there is a risk this may happen again, what steps are there to create a strategy to prevent it?

A company that truly incorporates quality thinking – through a CQMS – would be able to quickly answer these questions. It would have process management tools in place that would assist the CRA or study manager step-by-step to identify the issue and determine if a CAPA system is needed and what actions should follow.

Regulatory Emphasis

The current emphasis that global regulatory agencies are placing on risk management is now, more than ever, encouraging organisations to build quality management practices into every aspect of their businesses – including clinical trials. Evolving CTMS to CQMS and incorporating quality cornerstones like risk mitigation, risk management, root cause analysis, CAPA and training is a strategic move that can reduce costs and delays, improve quality and increase efficiencies.


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Patricia Santos-Serrao is a life sciences professional with nearly two decades of experience in regulatory affairs and clinical areas of the pharmaceutical industry. She is currently Market Segment Manager, Global Pharmaceutical, Blood and Biologics at MasterControl, a company that provides software solutions for quality and compliance to life sciences organisations.
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Patricia Santos-Serrao
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