In clinical development, we all strive to deliver therapies that improve patients’ lives. However, the clinical data we generate can profoundly impact our success in achieving this goal. A high-quality clinical data package 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. As such, ensuring data quality can increase your chances of successfully bringing your therapy to market or licensing it to another company.

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