Clymb Clinical
Clymb Clinical provides an AI-powered clinical reporting platform, Clymbr Hub, that automates the protocol-to-CSR workflow for biotech and pharmaceutical companies. The platform connects data mapping, SAP authoring, TFL generation, and CSR drafting in a validated, CDISC-aligned statistical computing environment, reducing programming effort from 1,600 to 650 hours on average. It also offers full-service outsourcing, FSP resourcing, and consulting for clinical data services.
- Artificial Intelligence
- Biotechnology
- Drug Discovery & Therapeutics
- Healthcare Technology
- Software Only
Funding
Founders
Product
Problem
Clinical trial sponsors face a fragmented, manual reporting pipeline where protocol, CRF, SDTM, ADaM, SAP, TFL, and CSR authoring are handled in disconnected tools and workflows. This results in significant time and cost burdens, with programming and QC alone consuming hundreds of hours per study, and introduces risks of errors, rework, and regulatory non-compliance.
Solution
Clymb Clinical provides Clymbr Hub, an AI-assisted, metadata-driven platform that unifies the entire protocol-to-CSR workflow in one validated statistical computing environment. The platform automates raw EDC data mapping to SDTM and ADaM, turns protocol and estimand intent into a structured CDISC ARS-ready SAP, generates production-ready SAS and R code with matching QC scripts, and drafts CSR narratives and in-text tables from approved TFLs. Every AI output is human-in-the-loop and fully traceable, ensuring compliance with 21 CFR Part 11 and CDISC standards. Clymbr Hub is non-disruptive, integrating into existing sponsor workflows without requiring a rip-and-replace migration.
Target Audience
Primary customers are emerging biotech, mid-size pharma, and large pharmaceutical companies, as well as CROs and technology vendors, seeking cost-effective clinical data services and platform licensing for biostatistics, statistical programming, data management, and submission support.
Features
- Data Mapper: AI-assisted raw-to-SDTM-to-ADaM mapping that reduces specification and mapping hours by 50-60%
- SAP Builder: Converts protocol and estimand intent into structured CDISC ARS-ready SAP metadata, cutting authoring effort by 80%
- TFL Designer + Code Generators: Generates production-ready SAS and R programs with matching QC scripts from ARS shells, reducing first-draft programming from 1,600 to 650 hours
- TFL Viewer + CSR Builder: Gen-AI drafting of CSR narratives and in-text tables from machine-readable, approved TFLs, covering CSR, ISS/ISE, annual reports, IB, and DSUR
- Runs in a 21 CFR Part 11 aligned, GxP-ready statistical computing environment with full audit trails, versioning, and access control
- Aligned with CDISC SDTM, ADaM, ARS/ARD, and Define.xml standards, with outputs ready for regulatory submission