CDISC/eSubmission
ClinChoice raises the standard of excellence in clinical data by ensuring your data is 100% CDISC compliant and fully validated, all within your timelines and budget. We’re proud to be a CDISC platinum member and a CDISC-registered solutions provider. We skillfully employ all CDISC standards, remain current with FDA submission guidance, and expedite implementation to promote efficient agency review.
CDISC Implementation & eSubmission Services
Our consulting services focus on process improvement and the implementation of CDISC SDTM and ADaM, which ultimately align company standards with current CDISC models. A key aspect is optimizing the data flow, ensuring a seamless transition from data capture using CDASH to SDTM, and further to ADaM, and facilitating the generation of tables, listings, and figures. Additionally, we optimize clinical toolsets to adhere to established standards and enhance overall ROI. Our consultancy includes knowledge transfer sessions to facilitate data standardization adoption. The implementation is guided by a comprehensive Study Data Standardization Plan (SDSP) to ensure a systematic approach.
Extensive SDTM & ADaM Experience
In the past five years, we’ve prepared more than 1000 SDTM / ADaM study packages across 75 compounds for 20 companies. We’ve created SDTM and ADaM for ISS and ISE packages, including large submission projects with up to 38 protocols from Phase I-III, conducted throughout the Americas, Europe, Asia-Pacific, and beyond.
- CDISC Platinum Member
- CDISC Registered Solution Provider
- Co-leader of a CDISC / FDA Data Integration Pilot
- Member of CDISC SDS Working Group
- Member of CDISC ADaM Working Group
- Member of CDISC XML-Tech Group
- Member of CDISC China Committee
Electronic Submissions Publishing
Our publishing services include complete lifecycle management of submissions with options for report-level publishing, submission publishing, compilation, and lifecycle maintenance for drug products and drug substances. Regulatory affairs works in an array of electronic formats, including electronic Common Technical Documents (eCTD), non-eCTD Electronic Submission (NeeS), paper submissions, and Structured Product Labeling (SPL).
Excellence in eSubmissions
ClinChoice is a CDISC-registered solutions provider and a CDISC Platinum Member. As an early adopter and contributor to CDISC standard development, ClinChoice ensures clinical data is fully validated and submission-ready. We drive efficiency and accuracy when submitting your NDA/BLA.