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Plenary Session Presentation: Putting Science First in Rare Disease Studies
Don´t miss Veristat’s plenary presentation at the World Orphan Drug Congress (WODC), Boston, Thursday, April 25th at...
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The Clinical Data Interchange Standards Consortium—more commonly referred to as CDISC - is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archival of clinical research data.
CDISC Data Standardization is becoming increasingly important as the FDA requests that all clinical data be migrated to 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: Provide standardized data sets that comply with CDISC Standards so the agency can adequately review your data.
In recent years the FDA has placed increasing emphasis on submitting standardized data, with the refusal cited above arguably being the highest profile example of the agency stressing the importance of standardized datasets and the implementation of CDISC data standards for agency review.
Veristat is a Clinical Research Organization (CRO) focused on capturing, managing, analyzing, and reporting clinical trial data. We are a recognized industry leader in CDISC Standards Implementation and the conversion of clinical data and datasets into CDISC compliant formats. Veristat is a CDISC Registered Solutions Provider in the following CDISC models: Trial Design, CDASH, SDTM, ADaM, and Define.xml.
We welcome the opportunity to discuss our CDISC Capabilities and how we can help you implement CDISC standards and convert your legacy studies to make them CDISC compliant.
For more information please contact us at info@veristat.com.
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Mar 22, 2024 Veristat Events
Don´t miss Veristat’s plenary presentation at the World Orphan Drug Congress (WODC), Boston, Thursday, April 25th at...
1 min read
Mar 19, 2024 Veristat Events
Meet Veristat in Basel at the Swiss Biotech Day, 22-23 April 2024
With nearly 30 years of experience in clinical trial...