Regulatory Data Standards (CDISC)

Summit Analytical staff are experts in the regulatory data sciences surrounding data standards and compliance with FDA mandated standards for submissions. The United States FDA now requires standardized data to be submitted with NDAs, BLA, and ANDA’s. We develop and provide our clients high quality:

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• Study Data Standardization Plans (SDSP) 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. In this guidance the development and submission of a SDSP with and IND is required. Summit Analytical supports our clients with the development and maintenance of the SDSP, and ensures that the plan is implemented throughout the life-cycle of a clinical development program.

• CDISC compliant Non-clinical SEND : The CDISC Standard for Exchange of Nonclinical Data (SEND) is the standard for which animal toxicology, ADME, and non-clinical animal PK/PD data are to be submitted with regulatory submissions. Summit Analytical are experts in the efficient development and validation of CDISC compliant, fully documented, submission ready, SEND datasets. This service is linked to our biostatistical support for toxicokinetics.

• Clinical SDTM and ADaM data ready for submission and use in the life cycle of a drug or device. Click here for more details.

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