Cdisc compliance services (sdtm, adam, send)

Rancho BioSciences provides expert CDISC mapping and conversion services for clinical and preclinical data, ensuring your datasets are submission-ready for FDA and EMA regulatory filings. Our team includes specialists in SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model), and SEND (Standard for Exchange of Nonclinical Data), with deep experience across therapeutic areas.

Why it matters: Regulatory agencies are increasingly strict on CDISC compliance, and data quality issues are a leading cause of FDA Refusal to File letters and costly submission delays. Many organizations — especially emerging biotechs — lack the internal expertise or bandwidth to handle CDISC mapping alongside ongoing trial operations.

How we work: We take your raw clinical or preclinical data (from EDC systems, central labs, imaging vendors, or legacy formats) and map it to the appropriate CDISC standard, creating submission-ready datasets with full traceability and audit trails. Our QC processes include automated validation checks plus manual expert review. We can also perform pre-submission audits to identify compliance gaps before they become regulatory findings.

Proof points: Rancho has collaborated directly with the FDA on a Real-World Evidence study in advanced NSCLC, validating methods for extracting endpoints from unstructured data. Clients report that our CDISC services have shaved weeks off submission timelines and reduced query rates. One VP of Translational Medicine noted we were "flexible under pressure... adjusting to emerging data — oh so rare these days."

Next steps: If you're preparing for a regulatory submission and need CDISC expertise — or want an independent audit of your current data to identify "Refusal to File" risks — reach out to discuss your timeline and requirements.