Full-service outsourcing, FSP resourcing , and Consulting all run by senior clinical data experts, all backed by the same validated automation stack.
Pick the model that matches the decision you're making , then change it as the program matures. The teams and tooling stay the same.
Biostatistics and Statistical Programming support , from protocol design and sample size calculations through SDTM mapping, ADaM and TFL programming, ISS/ISE, and regulatory submission support. Delivered by senior biostatisticians and statistical programmers.
A flexible, cost-effective outsourcing approach that lets sponsors and CROs extend their teams with Clymb experts for specific functions , biostatistics, statistical programming, data management, medical writing, or CDISC standards implementation.
Senior advisory on clinical data strategy, CDISC standards and metadata, Statistical Computing Environment design and validation, and automation or AI adoption , delivered as quantified assessments and executable roadmaps.
Every model draws on the same disciplines, so you can move work between them without re-training a new team on your study.
Design, sample size, SAPs, interim and DSMB analyses.
SDTM, ADaM, TFLs, and define.xml in SAS and R.
Data review, cleaning, reconciliation, and lock support.
CSRs, narratives, protocols, and submission documents.
ARS/ARD, custom macros, AI assistance, validation.
IND, NDA, BLA packages for FDA, EMA, and PMDA.
One study or one deliverable, with success criteria agreed up front.
Run it in the validated environment and measure hours, quality, and rework.
Move to program or portfolio level with the model the pilot proved.
We partner with pharma, biotech, CROs, and technology vendors on platform access, outsourcing, and FSP delivery.
