Discover The Value Of An Optimized Clinical Data Strategy
Data is the cornerstone of any clinical trial and is used to ultimately drive the decision-making process related to drug development. High-quality clinical data is a fundamental requirement for a new therapy to obtain approval from regulators like the Food and Drug Administration (FDA) or the European Medicines Agency (EMA), as well as other stakeholders such as payers and health technology assessment (HTA) agencies. Ensuring timely delivery of the highest quality of clinical data can increase the chances of successfully bringing your therapy to market or licensing it to another company.
However, generating high-quality clinical data is far from straightforward, especially if you don’t have the appropriate in-house expertise. In this eBook, we discuss the key elements of planning a clinical data strategy for the entire duration of a development program, specifically for Phase 1 and Phase 2 trials. We outline some of the best practices for planning your data strategy, and share insights from industry experts working in Cytel Strategic Consulting, Clinical Research Services and Data Management teams.
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