Clinical data,
submission-ready.

Clindar helps CRO and biotech teams move from raw trial data to clean, compliant, submission-ready SDTM and ADaM datasets — without enterprise-level complexity or cost.

GDPR-compliant by design
EU-hosted infrastructure
15+ years CDISC experience
Phase I to Phase III

Full-spectrum CDISC conformance — for the teams doing the work

Validate SDTM, ADaM, SEND, and Define-XML in one place. No SAS session. No enterprise contract. No rule sets frozen at last year's CT release.

Always-current rules

CORE-powered conformance rules and CDISC Controlled Terminology stay current automatically — covering clinical and nonclinical submissions alike. No manual updates before a filing deadline.

Fix issues faster

Inspect offending rows directly in the browser. Every error includes a plain-English explanation and actionable fix — not just a rule reference.

Submission readiness score

A clear quality metric per study — shareable with sponsors, suitable for reporting. Know exactly where you stand before you file.

The Validator is currently in development. Request early access.

Consulting services

Alongside our software, we provide hands-on biometrics consulting — drawing on 15+ years of CDISC submission experience.

  • End-to-end CDISC submission packages

    Full delivery of SDTM, ADaM, TLFs, and Define-XML — built to FDA and EMA standards, ready to file.

  • Clinical data management

    DMP authoring, EDC setup, edit check specification, query management, and database lock support.

  • Legacy dataset audit & remediation

    Audit and remediate existing SDTM or ADaM datasets before an agency inspection or re-submission.

  • Statistical programming support

    SAS and R programming for studies without in-house capacity — from derivations to final outputs.

  • Custom biometrics tooling

    Bespoke TLF automation, data review utilities, and submission output pipelines — built in SAS, R, or Python to fit your shells, SOPs, and sponsor requirements.

Built by people who've done the work

Clindar is founded on 15+ years of hands-on experience delivering CDISC-compliant submissions across global clinical trials — from first-in-human studies to pivotal Phase III packages filed with FDA and EMA.

We've lived the frustrations of slow tooling, expensive enterprise licenses, and rule sets that lag behind CDISC updates. Clindar is the tool we wished existed.

15+ Years CDISC experience
FDA & EMA Submission expertise
Phase I–III Trial coverage

Request early access

The CDISC Validator is in development. Leave your details and we'll reach out when early access opens — expected later this year — or to discuss consulting support in the meantime.

Your data is processed under GDPR Article 6(1)(a) — consent. We store only the information you provide, use it solely to respond to your enquiry, and will never sell or share it with third parties. You have the right to access, correct, or erase your data at any time.