Welcome to the DDF Solution Directory, here you will find a growing list of self-reported solutions which utilize and follow the DDF Unified Study Definitions Model (USDM). Below you will find a list of solutions which are currently using the USDM and other DDF tools to help promote developing and using fully digitized protocols. Please use this list as a starting point for researching DDF compatible solutions and come back frequently as our list of solutions and use cases grows!
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| Organization Name | Solution Name | Contact Email | Solution Description | More Info | Covered Use Cases | USDM Version Compatibility | Website |
|---|---|---|---|---|---|---|---|
| Novo Nordisk A/S | OpenStudyBuilder | The OpenStudyBuilder is an open-source project for clinical study specifications. This tool is a new approach for working with studies that once fully implemented will drive end-to-end consistency and more efficient processes - all the way from proto | More Information | Data storage in Metadata Repository (MDR) | 3.0 | LINK | |
| Nurocor Inc. | Nurocor Clinical Platform | Nurocor Clinical Platform is a software application suite to create study definitions and streamline the digital flow from protocol to submission. Our clients save, conservatively, $8M and 8 months on the median Phase 3 study. | More Information | Data storage in Metadata Repository (MDR), Decentralized Clinical Trials (DCT), Diverse and Inclusive Trial Design, Electronic Data Capture (EDC), Operational systems (i.e. CTMS, IRT, etc.), Patient elegibility screening, Registry reporting, Study authoring, Specimen management, template based clinical document authoring in general | 3.0 | LINK | |
| Faro Health Inc. | Faro Study Designer | The Faro Study Designer streamlines clinical trial protocol development with a digital-first approach, integrating real-time insights, modular design & AI. It addresses manual errors & automates tasks for seamless data flow from design to submission. | More Information | Data analytics and reporting, Decentralized Clinical Trials (DCT), Diverse and Inclusive Trial Design, Electronic Data Capture (EDC), Operational systems (i.e. CTMS, IRT, etc.), Study authoring, Digitalized Study Designer | 3.0 | LINK | |
| EQTY, Life Sciences | Verifiable Computations | Ensuring transparency, reproducibility, and control over protocol creation and adherence to current USDM standards is crucial. Our technology provides visibility into the downstream impacts of protocol changes on analysis and CSR. Regulators can trus | More Information | Data analytics and reporting, Data storage in Metadata Repository (MDR), Decentralized Clinical Trials (DCT), Diverse and Inclusive Trial Design, Electronic Data Capture (EDC), Electronic Health Record (EHR), eSource, Operational systems (i.e. CTMS, IRT, etc.), Registry reporting, Regulatory submission, Risk management, Study authoring, We are honored to be considered for designing a modern clinical data and computational environment for regulators. This will enable RWE submissions, AI use, and eliminate data submissions by sponsors, simplifying management for federal organizations. | 3.0 | LINK | |
| EZ Research Solutions | EZ Docs | EZDocs is an innovative software solution by EZ Research Solutions designed to revolutionize the clinical trial start-up process. This proprietary, patent-pending tool simplifies and accelerates the development of research studies by breaking the ent | More Information | Data storage in Metadata Repository (MDR), Decentralized Clinical Trials (DCT), Diverse and Inclusive Trial Design, eSource, Patient elegibility screening, Regulatory submission, Risk management, Study authoring | 2.0 | LINK | |
| Indegene, Inc. | Next Digital Protocol authoring | A web based User interface to author a new digital protocol using the Transcelerate Clinical Protocol Template (CPT) ( or a custom protocol template) utilizing standards specified in CDISC’s USDM v3.0 to create a machine-readable JSON file as well a | More Information | Data analytics and reporting, Data storage in Metadata Repository (MDR), Decentralized Clinical Trials (DCT), Diverse and Inclusive Trial Design, Electronic Data Capture (EDC), Study authoring, Beyond currently working solutions for Protocol digitization, authoring and accelerating Clinical study database (eDC) specification design as a DDF downstream use case, Indegene’s NEXT protocol authoring and database accelerator platform was architected to enable future downstream use cases beyond the digital protocol and clinical study database creation such as application and process accelerators for creating digitized documents such as the SAP, standard study TLF specifications and CSR content from a “One Source of Truth” approach These additional DDF downstream use cases are a work in progress currently as standards for these deliverables and documents evolve. | 3.0 | LINK | |
| TATA CONSULTANCY SERVICES LTD. | TCS ADD™ Metadata Repository | https://www.tcs.com/what-we-do/products-platforms/tcs-add/solution/tcs-add-metadata-repository-platform | More Information | Data storage in Metadata Repository (MDR), Electronic Data Capture (EDC) | 3.0 | LINK | |
| Sycamore Informatics | Sycamore SPA (Structured Protocol Authoring) | Sycamore SPA manages structured study definition with machine-readable Schedule of Activities. The configurable templates allow us to produce Study Protocol, CSR, SAP, etc. The SoA automates the study CRF and other downstream specifications in Sycamo | More Information | Diverse and Inclusive Trial Design, Electronic Data Capture (EDC), eSource, Study authoring | 3.0 | LINK | |
| Sycamore Informatics | Sycamore MDR (Metadata Repository) | Sycamore MDR is a metadata repository to manage Clinical Data Standards and build faster study specifications (EDC, DTS, SDTM) conforming to the standards and consume them for EDC build, SDTM transformation, etc. | More Information | Data storage in Metadata Repository (MDR), Diverse and Inclusive Trial Design, Electronic Data Capture (EDC) | 3.0 | LINK | |
| Sycamore Informatics | Sycamore CDR (Clinical Data Repository) | Sycamore CDR enables secure clinical trial and real-world data storage, with granular role-based access, version control, blinding/unblinding, and compliance with data provenance and chain of custody regulations like 21CFR11, EU Annex 11, and ICH E6. | More Information | Data analytics and reporting, Diverse and Inclusive Trial Design, Electronic Data Capture (EDC), eSource, Operational systems (i.e. CTMS, IRT, etc.), Regulatory submission | 3.0 | LINK | |
| Sycamore Informatics | Sycamore SCE (Statistical Computing Environment) | Sycamore SCE provides a single authoritative source for managing biostats and statistical programs. It offers version control, audit trails, traceable execution, dependency management, security, workflow and clinical reporting and analysis tasks. | More Information | Data analytics and reporting, Data storage in Metadata Repository (MDR), Regulatory submission, Statistical Computing Environment (SCE) | 3.0 | LINK | |
| Sycamore Informatics | Sycamore DTM (Data Transformation Module) | Sycamore DTM automates the study data transformation to produce submission-ready SDTM datasets and define.xml. | More Information | Data analytics and reporting, Data storage in Metadata Repository (MDR), Diverse and Inclusive Trial Design, Electronic Data Capture (EDC), eSource, Regulatory submission, Statistical Computing Environment (SCE) | 3.0 | LINK | |
| Sycamore Informatics | Sycamore DSW (Data Science Workbench) | Sycamore DSW allows reproducible clinical analyses using R and Python technologies within Sycamore SCE. It enables users to use R/Python programs and apps along with workflows, access control, and audit trail features. | More Information | Data analytics and reporting, Regulatory submission, Statistical Computing Environment (SCE) | 3.0 | LINK | |
| Sycamore Informatics | Sycamore ODR (Operational Data Repository) | Sycamore ODR enables users to access Sycamore SCE’s operational data in real time for reporting and visualization purposes. | More Information | Data analytics and reporting, Statistical Computing Environment (SCE) | 3.0 | ||
| tenXclinical | tenXclinical AI Platform for Clinical Trial Research Operations | A private AI platform that distills information for study operations teams to efficiently train sites and make clinical research operations less tedious, attain higher quality data, and become more efficient. | More Information | Decentralized Clinical Trials (DCT), Diverse and Inclusive Trial Design, Operational systems (i.e. CTMS, IRT, etc.), Regulatory submission, Risk management, Study authoring, Clinical Trial GPT Copilot, Clinical Site Training, Regulatory Essential Document creating, Study Startup | 2.0 | LINK | |
| NNIT | NNIT FHIR-USDM Methodology | The NNIT USDM-FHIR Methodology revolutionizes clinical protocol data exchange by mapping the Unified Study Definitions Model (USDM) to Fast Healthcare Interoperability Resources (FHIR). This approach streamlines integration with downstream systems li | More Information | Electronic Data Capture (EDC), Electronic Health Record (EHR), Operational systems (i.e. CTMS, IRT, etc.) | 2.0 | ||
| Citeline | TrialScope Disclose | TrialScope Disclose streamlines the clinical trial disclosure process with a unified platform that centralizes content and automates submissions to global registries. By eliminating duplication across multiple systems, the software minimizes complian | More Information | Operational systems (i.e. CTMS, IRT, etc.), Registry reporting, Regulatory submission, Risk management | 3.0 | ||
| Merative US L.P. | Zelta | Zelta, Merative’s clinical trial solution, offers a unified CDMS/EDC platform. Trusted by top pharma, biotech, and medical device companies, it’s been used in 4200+ trials across 100+ countries, covering all therapeutic areas and trial phases. | More Information | Decentralized Clinical Trials (DCT), Electronic Data Capture (EDC), eSource, Operational systems (i.e. CTMS, IRT, etc.), Patient elegibility screening | 3.0 | LINK | |
| Risklick | Protocol AI | Protocol AI is an end-to-end software that enables experts to quickly develop digital protocols and study documents, ensuring compliance with ICH M11 and USDM standards | More Information | Data analytics and reporting, Data storage in Metadata Repository (MDR), Decentralized Clinical Trials (DCT), Diverse and Inclusive Trial Design, Electronic Data Capture (EDC), Operational systems (i.e. CTMS, IRT, etc.), Patient elegibility screening, Risk management, Study authoring | 3.0 | LINK |