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International Clinical Trials

The Importance of Data Management in Clinical Trials

Clinical trial data are the backbone of any regulatory submission for marketing authorisation. Regulatory officials require complete, clear, and robust data, in a prescribed format, so they can thoroughly understand the benefits and risks of the drug product being reviewed.

Clinical data management (CDM) has a pivotal role in supporting regulatory submissions. Providing regulatory reviewers with robust data in the prescribed format reduces requests for clarification or a costly, time-consuming rework. When they receive high-quality, reliable, and statistically sound clinical trial data, sponsors can expect faster timelines from initial development to commercialisation.

It is now mandatory for companies to submit clinical trial data electronically. CDM professionals are ideally positioned to confirm that standards for data quality are met, and all data collected conform to rapidly evolving regulatory requirements.

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About the Authors

Cara White is a Senior Lead Data Manager at Altasciences with over eight years of research experience at clinical research organisations. She has extensive knowledge in several therapeutic areas, including SDTM and CDISC terminology. Prior to working in data management, Cara worked in Altasciencesí subject recruitment and clinical laboratory departments. Her experience in the clinic has provided her with additional insight and perspective on clinical operations and its flow into data management.

Dr Denise Milovan is a Scientific Manager of Biostatics at Altasciences. Throughout her career, she has provided oversight to neurocognitive early phase programmes dedicated to the assessment of the pharmacodynamic effects of CNS drugs. Dr Milovan also practices clinical neuropsychology in hospitals, non-profit organisations, and private practices. She holds a PhD and a Masterís degree in clinical neuropsychology and has also completed the requirements of a Masterís degree in clinical pharmacology. Since 2015, she has been an active member of the Council of the College of Psychologists of Ontario, Canada, and has previously served as Vice President of the Council.
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