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Critical Path Institute (C-Path) is a nonprofit, public-private partnership with the Food and Drug Administration (FDA) created under the auspices of the FDA’s Critical Path Initiative program in 2005.
C-Path’s aim is to accelerate the pace and reduce the costs of medical product development through the creation of new data standards, measurement standards, and methods standards that aid in the scientific evaluation of the efficacy and safety of new therapies.
These pre-competitive standards and approaches have been termed “drug development tools” (DDTs) by the FDA, which established a process for official review and confirmation of their validity for a given context of use.
C-Path orchestrates the development of DDTs through an innovative, collaborative approach to the sharing of data and expertise. We build consensus among participating scientists from industry and academia with FDA participation and iterative feedback. The process culminates in a formal application to FDA for official “qualification” of the DDT for a given use in product development. Qualified DDTs then become open standards for the scientific community which, in turn, may be assured both of the scientific rigor under which they were developed and of the FDA’s understanding and acceptance of their validity.
C-Path’s aim is to accelerate the pace and reduce the costs of medical product development through the creation of new data standards, measurement standards, and methods standards that aid in the scientific evaluation of the efficacy and safety of new therapies.
These pre-competitive standards and approaches have been termed “drug development tools” (DDTs) by the FDA, which established a process for official review and confirmation of their validity for a given context of use.
C-Path orchestrates the development of DDTs through an innovative, collaborative approach to the sharing of data and expertise. We build consensus among participating scientists from industry and academia with FDA participation and iterative feedback. The process culminates in a formal application to FDA for official “qualification” of the DDT for a given use in product development. Qualified DDTs then become open standards for the scientific community which, in turn, may be assured both of the scientific rigor under which they were developed and of the FDA’s understanding and acceptance of their validity.
Overview
Location
United States, Arizona
Employees
51-200
Phone
+1 520-547-3440
Founded date
2005
Mentions in press and media 27
| Date | Title | Description |
| Sign up to see | Sign up to see | Sign up to see |
| May 13, 2026 | eCOA Platform Innovator uMotif Launches Scientific Consulting Services | Led by global eCOA expert scientist Florence Mowlem PhD, new services bring sponsors and CROs deep and broad scientific leadership across all critical areas of clinical trial and real-world study design BOSTON and LONDON, May 13, 2026 /PRNe... |
| Jan 29, 2026 | uMotif Posts Strong Growth, Earns Market Accolades for eCOA Platform, Demonstrates Continued Clinical Trial Industry Leadership in 2025 | Everest Group gives uMotif highest possible technology rating in eCOA market assessment; Chief Scientific Officer Florence Mowlem PhD leads C-Path publication of industry-wide Event-Driven eDiary best practices in Nature Digital Medicine; f... |
| Dec 15, 2025 | uMotif Chief Scientific Officer Leads Publication of Fundamental Work Detailing Industry-Wide Recommendations for Adopting Event-Driven eDiaries in Clinical Trials | On behalf of the Critical Path Institute (C-Path) Florence Mowlem PhD, led this much-needed project, providing 10 best practices for EDeD design and implementation to support clinical trial data capture, along with co-authors from Top 10 ph... |
| Jun 18, 2025 | Navigating the Future of Liver Disease and Diabetes Management: Innovations on the Horizon | In the ever-evolving landscape of healthcare, two conditions are gaining attention: metabolic dysfunction-associated steatotic liver disease (MASLD) and Type 1 Diabetes (T1D). Both present unique challenges and opportunities for innovation.... |
| Jun 16, 2025 | Diamyd Medical to participate in two key US diabetes events | Diamyd Medical to participate in two key US diabetes events Mon, Jun 16, 2025 15:05 CET Report this content Diamyd Medical participates in two significant events in the field of diabetes; the Critical Path Institute (C-path) Workshop: 21st ... |
| Jan 15, 2025 | Increasing Participation in Muscular Dystrophy Clinical Trials | Michel van Harten M.D., CEO of myTomorrows Muscular Dystrophy (MD) refers to a group of rare genetic conditions that cause progressive muscle weakness and degeneration in patients. Some forms of MD, such as Duchenne Muscular Dystrophy (DMD)... |
| Aug 12, 2024 | Rare Disease Cures Accelerator | To support innovation and quality in rare disease drug development Over the past decade, progress has been made in planning and conducting clinical trials for rare disease drug development. In 2018, for the first time ever, a majority of ne... |
| Jul 26, 2024 | Digital Health Innovations: A New Dawn for Parkinson's and Multiple Sclerosis** ** | ** In the ever-evolving landscape of healthcare, digital health technologies are emerging as powerful allies in the fight against chronic diseases. Two recent developments highlight this trend: the expansion of the Digital Health Measuremen... |
| Jul 23, 2024 | DATAcc by DiMe Expands Library of Digital Measurement Products to Include Parkinson's Disease | Parkinson's disease marks the fourth category for the library, highlighting industry leader commitment to accelerating research through open science BOSTON, July 23, 2024 /PRNewswire/ -- Today, the Digital Health Measurement Collaborative C... |
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FAQ about Critical Path Institute (C-Path)
When was Critical Path Institute (C-Path) founded?
Critical Path Institute (C-Path) was founded in 2005.
What has the press written about Critical Path Institute (C-Path)?
Parsers VC has collected 27 articles mentioning Critical Path Institute (C-Path), among them “eCOA Platform Innovator uMotif Launches Scientific Consulting Services” (May 13, 2026) and “uMotif Posts Strong Growth, Earns Market Accolades for eCOA Platform, Demonstrates Continued Clinical Trial Industry Leadership in 2025” (Jan 29, 2026).
Is Critical Path Institute (C-Path) still active?
Yes, Critical Path Institute (C-Path) is active; its latest activity on Parsers VC dates from Jun 23, 2026.