Master SEND Data Compliance and Accelerate Drug Development
Navigating the complexities of regulatory submissions can be tough for pharmaceutical R&D professionals. Presenting nonclinical study data in a consistent and compliant format can be challenging!
Fortunately, the Clinical Data Interchange Standards Consortium (CDISC) SEND (Standard for the Exchange of Nonclinical Data) provides a structured approach to meeting FDA requirements.
This white paper gives an overview of how to submit datasets in SEND format. It also offers valuable insights into how to streamline your submission and avoid common pitfalls. By reading it, you’ll learn about:
- The components of a SEND package and its application in FDA regulatory reviews.
- The evolving landscape of SEND implementation guides (SENDIGs) and data standards.
- The requirements for specific study designs, FDA centers, and submission types.
Streamline Your SEND Submissions and Avoid Delays. Download the Free White Paper Now
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