Critical Path Institute
Critical Path Institute (C-Path) is a nonprofit organization dedicated to improving and streamlining the process of drug development. By fostering collaboration between industry executives, scientists, academic researchers, regulators, and patient groups, C-Path aims to accelerate the development of therapies for people with unmet medical needs.
Industries
N/A
Products
Model-based clinical trial simulation and enrichment toolset
Model-based simulation and enrichment tools that implement disease-progression and drug–disease–trial models to evaluate sample size, enrichment strategies, assessment schedules and analytic methods across therapeutic areas.
Rare disease data and analytics platform (RDCA-DAP)
Centralized platform that aggregates and standardizes patient-level rare disease data from clinical trials, registries and real-world sources to accelerate disease characterization, biomarker development and quantitative-modeling efforts.
Disease-specific integrated databases and registries
Curated repositories that store standardized, de-identified patient-level data (demographics, clinical scales, outcomes, biomarker/imaging data) with controlled access for qualified researchers to support modeling, endpoint development and COA analyses.
Friedreich's Ataxia Integrated Clinical Database (FA-ICD)
Curated repository of Friedreich’s ataxia clinical-trial and natural-history data standardized to CDISC format and made available to qualified researchers to support modeling and outcome-measure evaluation.
Rare disease knowledge graph
A knowledge graph constructed to harmonize rare-disease metadata and enable semantic queries and integration across clinical, registry, and real-world data.
Model-based clinical trial simulation and enrichment toolset
Model-based simulation and enrichment tools that implement disease-progression and drug–disease–trial models to evaluate sample size, enrichment strategies, assessment schedules and analytic methods across therapeutic areas.
Rare disease data and analytics platform (RDCA-DAP)
Centralized platform that aggregates and standardizes patient-level rare disease data from clinical trials, registries and real-world sources to accelerate disease characterization, biomarker development and quantitative-modeling efforts.
Disease-specific integrated databases and registries
Curated repositories that store standardized, de-identified patient-level data (demographics, clinical scales, outcomes, biomarker/imaging data) with controlled access for qualified researchers to support modeling, endpoint development and COA analyses.
Friedreich's Ataxia Integrated Clinical Database (FA-ICD)
Curated repository of Friedreich’s ataxia clinical-trial and natural-history data standardized to CDISC format and made available to qualified researchers to support modeling and outcome-measure evaluation.
Rare disease knowledge graph
A knowledge graph constructed to harmonize rare-disease metadata and enable semantic queries and integration across clinical, registry, and real-world data.
Services
Consortium facilitation and pre-competitive collaboration
Neutral convening and management of multi-stakeholder consortia and working groups to align scientific, regulatory, industry and patient-community objectives and develop shared tools and standards.
Managed data platform hosting and controlled data access (RDCA-DAP)
Curation, standardization, secure hosting and request/approval access mechanisms for patient-level datasets supporting research, modeling and regulatory activities across rare and orphan diseases.
Regulatory science training and education
Curricula, webinars and certificate programs covering model-informed drug development, clinical outcome assessment and regulatory science topics for drug development professionals.
Analytical and evidentiary guidance for biomarker qualification
Development and dissemination of frameworks, white papers and workshops describing analytical validation expectations and evidentiary criteria for biomarker qualification.
Data standardization and ETL services to CDISC standards
Transformation and mapping services to convert heterogeneous clinical and nonclinical data formats into CDISC SDTM, SEND and related therapeutic-area standards, plus support for contributor submissions and data contribution agreements.
Programmatic support for disease-focused public-private partnerships
Operational and scientific support for disease-specific consortia to advance natural-history characterization, biomarker evaluation, COA development and trial-design tools within a neutral pre-competitive framework.
Consortium facilitation and pre-competitive collaboration
Neutral convening and management of multi-stakeholder consortia and working groups to align scientific, regulatory, industry and patient-community objectives and develop shared tools and standards.
Managed data platform hosting and controlled data access (RDCA-DAP)
Curation, standardization, secure hosting and request/approval access mechanisms for patient-level datasets supporting research, modeling and regulatory activities across rare and orphan diseases.
Regulatory science training and education
Curricula, webinars and certificate programs covering model-informed drug development, clinical outcome assessment and regulatory science topics for drug development professionals.
Analytical and evidentiary guidance for biomarker qualification
Development and dissemination of frameworks, white papers and workshops describing analytical validation expectations and evidentiary criteria for biomarker qualification.
Data standardization and ETL services to CDISC standards
Transformation and mapping services to convert heterogeneous clinical and nonclinical data formats into CDISC SDTM, SEND and related therapeutic-area standards, plus support for contributor submissions and data contribution agreements.
Programmatic support for disease-focused public-private partnerships
Operational and scientific support for disease-specific consortia to advance natural-history characterization, biomarker evaluation, COA development and trial-design tools within a neutral pre-competitive framework.
Expertise Areas
- Clinical trial simulation and model-informed trial design
- Patient-level data standardization and CDISC implementation (SDTM, SEND)
- Disease-progression and nonlinear mixed-effects modeling
- Biomarker qualification and evidentiary framework development
Key Technologies
- CDISC SDTM
- CDISC SEND
- Nonlinear mixed-effects modeling
- Disease-progression modeling