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Right First and Every Time

In recent years, a number of regulatory agencies, scientific bodies, and healthcare organisations have introduced many initiatives to improve the effectiveness and quality of clinical research. However, challenges are still evident when it comes to balancing safety and efficiency in clinical research. Thus, it has been repeatedly stated that better quality management and a different approach is needed urgently. Evolution needs to be driven for safer, more effective clinical research based on principles of minimising harm, removing waste, and managing variation. This requires a more systematic approach.

Good Clinical Practice (GCP) guidelines are simply not enough to ensure safety nowadays. One of the reasons for this is that these are regulations that offer the workflow of documentation and the structure of clinical trials, but the control over how people are implementing them is far too low. To address this challenge, developing standardisation processes of the investigator sites and a database of these accredited sites came into effect in many clinical trials. This standardisation covers all aspects of documentation, patient engagement, and professional qualification of the organisation, where the clinical trials are going to be conducted. Instead of focussing only on the way the site follows ICH GCP regulation, the efficiency profile of the investigator sites will need to be ensured.

Appropriate, proportionate standards that focus on the things that matter are necessary. Beyond any revisions to the existing guidelines or the creation of new sets of guidance, wider cultural change is required to ensure that guidance is implemented appropriately.

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Dr Suzanne Pavon is Chief Quality and Compliance Officer, Executive Vice President of Quality Management, Corporate Compliance, and Legal at TFS. Suzanne is an entrepreneurial leader and senior executive with over 20 years’ global experience in the pharmaceutical, biotechnology, and CRO industry. Previous roles include a number of senior leadership positions in quality management, compliance, and clinical operations. She has worked at Novartis, Clinigen, uniQure, Teva, Sanofi, and Genzyme, including five years working at Mayo Clinic, US, and the King Hussain Cancer Center, Jordan. Suzanne is a graduate of Philadelphia University, US, and Harvard School of Public Health, US, and has earned a PhD in oncology, a PharmD, and Certified Professional in Healthcare Quality status.
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Dr Suzanne Pavon
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