Clinical Data Standards
In 2013, FDA’s has released 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” was made very clear. Following which towards 2014, the FDA finalized Binding Guidance documents that make submission of electronic data mandatory, and also 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 will require CDISC standards for all submissions. Eventually submissions that do not comply with the CDISC requirements after the stipulated timeframe could potentially receive a Refusal to File (RTF) from the agency. Thus, all studies that start in 2017 or later will be required to submit their data to the FDA in an electronic format that uses CDISC data standards.
The Clinical Data Standards Services Offered by Clinnex include:
Our CDISC Expertise
We ensure there is an accurate interpretation of the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) that is 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 proper quality embedded procedures which also brings in cost efficiency.
