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International Clinical Trials

Focal Point

Most efforts to enhance trial processes hope to bridge the gap between the biopharmaceutical sector and individuals living with a disease. To date, clinical operations (ClinOps) have only been a small part of these attempts, but there is huge potential for them to increase the patient centricity of study execution and, in turn, the satisfaction of patients.

There are three primary advantages of taking a patient-centric approach to ClinOps (see full PDF for Figure 1). First, they can reduce leakage through the enrolment process to increase retention and minimise the pressure on recruiting new subjects. Second, ClinOps are uniquely positioned to manage protocol compliance to avoid costly amendments, and ensure that patients remain in the trial as long as they stand to benefit from it. Finally, with access to real time patient-level data, ClinOps are able to quickly respond to any safety and logistical issues by dedicating additional resources to the studies and sites most in need.

The notion that ClinOps can have a major impact on the patient experience is not particularly new – but access to high-quality, real time and cross-study insights is. The arrival of a new class of software – called clinical intelligence – that aggregates disparate trial data to deliver information on key performance indicators for clinical research teams has been heralded as a significant technological achievement.

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Bruno Gagnon is co-author and former Vice President of Clinical Operations at BioMarin. As a 25-year industry veteran, Bruno now spends most of his time as an Executive Consultant, leading emerging life sciences companies and teaching at San Francisco State University in the Clinical Trial Design and Management Certificate Program.

Nick Payton is co-author and leads the Marketing department at Comprehend. The company provides cloud clinical intelligence software to enable leading life sciences organisations to deliver trials more quickly and with improved data quality.

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Bruno Gagnon
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Nick Payton
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