Validating cdisc sdtm compliant submission ready clinical datasets
Regulatory Agency Requirements In December 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.
He is fully-versed in e CTD format and has authored a variety of CMC submissions, including numerous pre-IND meeting packages, INDs, NDAs, and IMPDs.
IDDCR employs experienced professionals across the United States and India primarily engaged in the areas of Biostatistics and SAS Programming, Data Management (EDC, Hybrid and Paper), CDISC consulting, Pharmacovigilance, and Medical writing.
JSS provides biostatistics & statistical programming services to its clients in the entire clinical development cycle – protocol development, study design, statistical analysis, and regulatory submission.
Our history is almost as interesting as our present.
In 2008, our principals created the game-changing Open CDISC Validator — an open-source tool for ensuring SDTM and ADa M compliance.Pinnacle 21 is also a Platinum Member of CDISC, as well as a CDISC technology partner.