Clymb Clinical


Clymb Clinical is a startup specializing in clinical data services, leveraging technology and open source solutions to provide flexible, cost-effective clinical trial solutions worldwide. The company aims to innovate, integrate, and improve clinical data analytics, supporting clients' clinical trials with high standards of quality and compliance while minimizing costs and accelerating time to market. They focus on transforming clinical data analysis through tools like TFL Designer, automation, and data standards such as CDISC ARS, and are actively involved in industry events and collaborations to advance clinical research standards.

Industries

biopharma
biotechnology
clinical-trials

Nr. of Employees

small (1-50)

Clymb Clinical

Burlington, Massachusetts, United States, North America


Products

Web-based TFL design and automation tool (community and enterprise)

A web application to build TFL shells, capture machine-readable metadata, manage TFL standards/templates, and enable automated generation of analysis outputs and downstream code.

R package for Analysis Results Dataset automation

An R package that automates generation of Analysis Results Datasets and the R scripts used to produce them, using CDISC ARS-aligned metadata.


Services

Provision of end-to-end clinical data services including protocol/design support, statistical analysis, SDTM/ADaM mapping, TFL programming, regulatory submission support, and rescue work for troubled studies.

Dedicated functional teams to insource specific data and analytics functions, providing project-managed resources for long-term or program-level needs.

Strategic and niche consulting including regulatory strategy, GxP business analysis, IT QA, computer systems validation, and project-level advisory for clinical development.

Design and implementation of interactive dashboards and visualizations for clinical data to enable exploratory analysis and stakeholder reporting.

Specialized support for preparing regulatory submission packages, ensuring compliance with submission standards and generation of submission artifacts.

Support for adoption, customization, and integration of open-source tools and community packages for data manipulation, visualization, ADaM generation, and SDTM mapping.

Expertise Areas

  • Clinical trial statistical design and analysis
  • Statistical programming and automation (SAS/R)
  • CDISC implementation and submission-ready dataset development
  • Clinical data management and EDC/CRF design
  • Show More (6)

Key Technologies

  • R programming
  • SAS programming
  • R Shiny (interactive web apps)
  • Enterprise analytics platforms (enterprise BI/analytics)
  • Show More (6)

News & Updates

A highly anticipated annual event that fosters collaboration among leaders in data science, statistical programming, and healthcare industry to shape the future of clinical development.

A conference scheduled for June 11, 2025, in Waltham, MA, focusing on statistical data exchange and development.

A key industry event from October 13-17, 2025, in Nashville, TN, exploring clinical data standards and regulatory compliance.

A conference from June 1-4, 2025, in San Diego, CA, dedicated to statistical programming and clinical research methodologies.

Collaboration with CDISC to launch ARS-compliant packages in the eTFL Portal, modernizing analysis results management.

Automating the creation of TFLs using TFL Designer, CDISC ARS standard, and R scripts, showcased at PHUSE US Connect 2025.

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