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BackMarch 2, Uppsala, Sweden

Risk Based Quality Management

Gunnar Danielsson

Risk Based Quality Management

PCG Clinical Services effectively looking at the essentials

Text by: Gunnar Danielsson

Gunnar Danielsson is PCG Clinical Services’ Sr. Regulatory Advisor. He is a highly regarded speaker in the Life Science Industry and is scheduled to give a presentation at the SCDM 2016 European Leadership Forum this March. With a B.Sc. in Natural Science and 40 years’ experience in Clinical Research, Gunnar has served as a renowned GCP Inspector for the Swedish MPA for over 10 years. He also has experience from the Pharmaceutical Industry in terms of quality management, electronic systems, data management, clinical study design and conduct. Gunnar is a key advisory resource to help design studies in the most effective way, meeting regulatory requirements.

All clinical trials should be conducted in such a way and standard that the quality is fully acceptable for regulatory purposes. Sponsors and CROs spend a great deal of resources, money and effort in order to ensure the quality is being upheld. Over the last decades a shift in ensuring quality has emerged and many players have introduced 100 % source data verification (SDV) in order to fulfil data quality requirement. There is however, a misconception that quantity is better than quality. Quantity is not the same thing as quality - reviewing a lot of data does not improve the quality. Furthermore, this (SDV) approach is resource and cost demanding and has not given the improved quality intended.

The regulatory agencies, like EMA and FDA, have identified this problem and issued guidelines for the industry to help improve quality without increasing the cost for clinical trials. This process, called risk based quality management or risk based monitoring and it is intended to persuade the industry to abandon the traditional way of 100% SDV in clinical trials and instead try alternative methods. The principle of risk based quality management is very simple. It directs the sponsors to focus on the most relevant processes and data points used in a specific study and spend less time on data and processes that are not so important for the outcome of the study. Risk based quality management includes both on-site monitoring and central monitoring. The on-site monitoring focuses on the compliance of the protocol at site and the documentation of the collected data and processes, while the central monitoring focuses on the review and assessment of the data reported to the sponsor via the electronic Case Report Form (eCRF). These two together will ensure that the patient integrity and safety is upheld and that the data collected is trustworthy.

PCG Clinical Services AB (PCG) has fully embraced the concept of risk based quality management. In practice this means that for each study, potential risks and important data items are identified and quality oversight is concentrated on the relevant parts of the study. This process is transparent, well documented and is conducted in collaboration with the sponsor. By working according to these principles, PCG is able to both improve the quality and ensure that the regulatory requirements are fulfilled. At the same time the costs for the sponsor conducting the study is very often reduced. In addition, risk based quality management gives an early indication if, for some reason, something starts going in the wrong direction. This allows a quick response for efforts and resources to focus on solving the potential issue.

PCG Clinical Services is a Swedish customer service CRO. Our team of experts have made PCG Clinical Services the fastest growing CRO in Scandinavia, conducting phase I-IV studies world wide. We provide years of experience, customized solutions and advisory for our customers. Follow our LinkedIn company page for company news, updates and relevant articles regarding our industry.