The Importance of Successful Implementation of CDISC Data Standards

Veristat, Inc.Nicole Powell, 214-432-6126

The Clinical Data Interchange Standards Consortium ( is a global, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archival of clinical research data.

is becoming increasingly important as the requests all clinical data be submitted in a standardized format for review and approval.

For example, on August 27, 2012, a prominent Pharmaceutical company issued a press release stating that it had received a Refuse to File letter from the FDA in response to its supplemental Biologics License Application (sBLA), revealing that “after collaborative consultations with the FDA, the agency requested that the company modify the presentation of the data sets to enable the agency to better navigate the application.” Translation

In recent years the FDA has placed increasing emphasis on submitting standardized data. And the refusal cited above is arguably the highest profile example of the agency stressing the importance of standardized datasets and the implementation of CDISC data standards.

is a recognized industry leader in and the of clinical data into compliant formats. Veristat is a in the following CDISC models: and.

We welcome the opportunity to discuss our and how we can help you implement CDISC standards and convert your legacy studies to make them CDISC compliant.

Veristat, Inc. is an innovative, science-focused clinical research organization (CRO) with nearly twenty years of dynamic expertise in supporting clinical trials and regulatory submissions. We offer comprehensive services, including biostatistics, programming, medical writing and data management, as well as preparation of integrated summary documents and submission-ready CDISC data. Please find more at .

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