Summit Biostats staff are experts in regulatory data science and the data standards required to comply with FDA mandated standards for submissions. The US FDA now requires standardized data to be submitted with NDAs, BLAs, and ANDA’s. We can help you provide a high-quality submission that will meet FDA’s standards. In addition, we can help with the following.

 

•  Study Data Standardization Plan (SDSPs) for a drug or device development program. [On February 17, 2014, the FDA Guidance on Providing Regulatory Submissions in Electronic Format—Standardized Study Data was published as final and binding. Per this guidance, the development and submission of an SDSP is required with an IND.

 

      Summit Biostats supports our clients in the development and        maintenance of the SDSP and ensures that the plan is

      implemented throughout the life-cycle of a clinical

      development program.

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• CDISC compliant Non-clinical SEND. The CDISC Standard for Exchange of Nonclinical Data (SEND) is the standards for submitting animal toxicology, ADME, and non-clinical animal PK/PK data with regulatory submissions.

 

      Summit Biostats staff are experienced in the efficient

      development and validation of CDISC-compliant, fully-

      documented, submission-ready, SEND dataset.