Data is the most crucial asset in any clinical trial and is used to ultimately drive the decision-making process related to the development candidate. Therefore, for any sponsor, paying close attention to the data management aspects of clinical operations should be paramount. The principles of data management are simple and well-founded. However, the application of these principles needs careful consideration, depending on various scenarios and the size of the organization. When implementing data management for your trial, it is critical to plan ahead and fully understand all the steps and activities involved.
Fortunately, both strategic and tactical opportunities are available to help sponsors successfully implement a data management strategy, and ensure quality and simplicity in data collection to enable subsequent analysis. In this ebook, we outline some considerations to help sponsors navigate key decisions that need to be made throughout data management implementation.
We discuss the importance of establishing clear data standards for both operational efficiency and regulatory purposes; the practicalities of selecting an electronic data capture system; how to ensure your data is processed quickly and to a high level of quality; and managing a close alignment between data management and statistics functions.
by Paul Fardy
About Paul Fardy
Paul Fardy is Executive Director of Data Management at Cytel and leads the company’s clinical data management operations in the USA, Europe, and India. Prior to joining Cytel, he has held leadership positions within CROs and pharmaceutical organizations including Eisai, Ipsen, and GlaxoSmithKline.