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.
Modern CDISC validation without enterprise complexity
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.
A live preview of the Clindar Validator interface.
The Validator is currently in development. Request early access.
Expert support when software isn't enough
Clindar combines modern validation software with specialist clinical-data expertise for the parts of submission readiness that still require human judgement.
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Submission readiness & CDISC delivery
SDTM, ADaM, Define-XML, and submission outputs prepared, reviewed, and validated for FDA and EMA submission. From study data transformation through final submission-readiness review, we provide focused CDISC expertise where internal teams need additional capacity or specialist support.
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CDISC audit & remediation
Independent review, investigation, and remediation of SDTM, ADaM, and Define-XML before submission, inspection, or transfer between vendors. We identify conformance issues, investigate their causes, and help teams resolve validation findings efficiently — particularly where inherited datasets or vendor transitions require specialist review.
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Submission programming & automation
Targeted SAS, R, and Python expertise for CDISC transformations, validation workflows, submission outputs, and repeatable clinical data automation — including dataset transformations, validation pipelines, data review utilities, and TLF production.
Built by someone who's 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.
That experience spans SDTM, ADaM, Define-XML, and SEND across SAS, R, and Python — and a long familiarity with the slow tooling, expensive enterprise licenses, and rule sets that lag behind CDISC updates that small CRO and biotech teams have to deal with. Clindar is the platform that should have existed.
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 expert support in the meantime.
Registered company details
Clindar, UABCompany code 308107046
Registered office: Laisvės pr. 78-11, LT-05263 Vilnius, Lithuania
info@clindar.eu