Data is the cornerstone of any clinical trial and is used to ultimately drive the decision-making process related to the drug development. The quality of your clinical evidence package is an important factor in gaining approval from key decision-makers, including regulators, payers, and health technology assessment (HTA) agencies. So, how can you generate high-quality clinical data, especially when you don’t have the appropriate in-house expertise?
Cytel’s new Data Management eBook is a guide for effectively planning your data strategy. Our industry experts share insights and outline some of the best practices for planning your data strategy for the entire duration of a development program, specifically for Phase 1 and Phase 2 trials. It also offers a glimpse into incorporating some less familiar innovations, such as using historical data and optimizing data strategy with quantitative pharmacometrics.
Why the emphasis on planning your data strategy?
There are several reasons why it is important to plan a data strategy for your clinical program. The key objective is to protect the quality of your clinical data. A data strategy helps you to define your approach to data collection, storage, and analysis, such as selecting a suitable electronic data capture (EDC) system and implementing ways to standardize data transformation processes. It is vital for identifying and plugging information gaps proactively and in real-time to minimize delays while improving data quality. It is also important to follow a holistic approach, for example at Cytel, our biostatisticians, programmers and data managers collaborate up front to ensure the design, build and delivery is fit for purpose. (To learn more read our interview with Jessica Bhoyroo).
You also need to be mindful of the risks of overlooking a strategic data plan. Without it, the quality of the evidence package suffers and reduces the likelihood that decision-makers will approve the new therapy. Adopting key tactics to preserve data quality can mitigate these risks and enhance clinical development. It also increases the possibility of gaining a return on investments and improves the chances of new therapies reaching the patients.
Download the eBook to learn the top tips on optimizing your data strategy.
About the Author of Blog:
Mansha Sachdev specializes in content creation and knowledge management. She holds an MBA degree and has over 11 years of experience in handling various facets of marketing, across industries. At Cytel, Mansha is a Content Marketing Manager and is responsible for producing informative content that is related to the pharmaceutical and medical devices industries.