Clinical Data Standards
Why Do we need Data Standardization?
In 2013, the FDA released a statement on the importance of standardized study data and its positive impact on a 'reviewer’s ability to more fully understand and characterize the efficacy and safety of a medical product'. Subsequently, in 2014, the FDA finalized binding guidance documents that make the submission of electronic data mandatory and require the data to be in a standard format that the FDA can process, review, and archive.
By the end of 2016, both the FDA and PMDA required CDISC standards for all submissions. Submissions that do not comply with the CDISC requirements after the stipulated timeframe could potentially receive a Refusal to File (RTF) from the agency. Therefore, all studies that started in 2017 or later are required to submit their data to the FDA in an electronic format that uses CDISC data standards.
Clinical Data Standard Services Offered by ERIC
- Data Standards Library
- Data Migration Projects to CDISC
- Standard Mapping
- Programming Services
ERIC’s CDISC Expertise
We believe that the upfront implementation of data standards in a sponsor’s data management and statistical environment enables sponsors to map data specifications to their clients and agencies smoothly. ERIC has provided its healthcare partners with clinical data standardization services since its inception. Our team of expert programmers understands all aspects of clinical trial data generation in clinical research.
"We ensure accurate interpretation of the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM), which are identified, documented, managed, implemented consistently, and, most importantly, communicated to the sponsor. We are well-positioned to execute CDISC – SDTM & ADaM conversion projects smoothly. We deliver all this through properly embedded quality procedures, which also bring cost efficiency.