The Emmes Company LLC
The Emmes Group is a global leader in clinical research, dedicated to delivering impactful health solutions through innovative science and technology. With a history spanning over 47 years, the company specializes in clinical trials, regulatory affairs, data management, and AI-powered solutions, supporting public health initiatives and advancing medical research worldwide.
Industries
Nr. of Employees
Very Large (1000+)
Products
AI agent for data management
An AI assistant that automates study build tasks, discrepancy detection, query review, protocol compliance checks, data quality monitoring, and SDTM conversion pipelines to accelerate data readiness.
AI agent for biostatistics and analysis
An AI-driven tool that automates TFL shell generation, assembles interim and DSMB packages, standardizes outputs, and prepares analysis-ready deliverables.
AI document authoring copilot
AI-assisted document generation for clinical study documents (protocols, reports, regulatory submissions) trained with domain expert oversight to produce structured, regulatory-aligned drafts.
Unified eClinical platform
A fully integrated cloud-based platform combining EDC, IRT/RTSM, ePRO/eCOA, eConsent, DCT enablement, specimen tracking, operational dashboards and reporting.
Clinical data analytics pipelines
Automated analytics workflows for large and complex biological datasets, including real-world data and omics, to generate disease and treatment insights.
AI agent for data management
An AI assistant that automates study build tasks, discrepancy detection, query review, protocol compliance checks, data quality monitoring, and SDTM conversion pipelines to accelerate data readiness.
AI agent for biostatistics and analysis
An AI-driven tool that automates TFL shell generation, assembles interim and DSMB packages, standardizes outputs, and prepares analysis-ready deliverables.
AI document authoring copilot
AI-assisted document generation for clinical study documents (protocols, reports, regulatory submissions) trained with domain expert oversight to produce structured, regulatory-aligned drafts.
Unified eClinical platform
A fully integrated cloud-based platform combining EDC, IRT/RTSM, ePRO/eCOA, eConsent, DCT enablement, specimen tracking, operational dashboards and reporting.
Clinical data analytics pipelines
Automated analytics workflows for large and complex biological datasets, including real-world data and omics, to generate disease and treatment insights.
Services
Full-service site and study operations including site identification, feasibility, activation, monitoring, training, recruitment support, and patient safety oversight.
End-to-end data services from protocol-driven data planning and eCRF design to database development/validation, query management, coding, SDTM conversion and database lock.
Design and analysis services including protocol design support, SAPs, interim analyses, DSMB packages, and final reporting.
Regulatory strategy, gap analysis, document preparation (IND/IDE/CTA/NDA/BLA/CTD), pre-meeting packages, CMC support, and multi-region submission coordination.
Safety case processing, medical review, safety reporting, analysis, and submission of safety documentation to regulatory authorities.
Clinical investigation management, protocol development, testing oversight, regulatory filing support, vigilance system development, and post-market surveillance assistance including CE marking support.
Full-service site and study operations including site identification, feasibility, activation, monitoring, training, recruitment support, and patient safety oversight.
End-to-end data services from protocol-driven data planning and eCRF design to database development/validation, query management, coding, SDTM conversion and database lock.
Design and analysis services including protocol design support, SAPs, interim analyses, DSMB packages, and final reporting.
Regulatory strategy, gap analysis, document preparation (IND/IDE/CTA/NDA/BLA/CTD), pre-meeting packages, CMC support, and multi-region submission coordination.
Safety case processing, medical review, safety reporting, analysis, and submission of safety documentation to regulatory authorities.
Clinical investigation management, protocol development, testing oversight, regulatory filing support, vigilance system development, and post-market surveillance assistance including CE marking support.
Expertise Areas
- Clinical trial management
- Clinical data management
- Biostatistics and adaptive trial design
- Regulatory affairs and submissions
Key Technologies
- Electronic data capture (EDC)
- IRT/RTSM (interactive response technology)
- eCOA / ePRO
- eConsent
News & Updates
Press release announcing Germaine Gross as Chief Commercial Officer.
Press release about expanding government collaborations.
Press release about a new contract supporting NIDAS clinical trials network.
Article about Emmes' submission for Duchenne disease.
Press release about leadership change at Veridix.
Press release about the formation of Emmes Group.
Press release announcing Germaine Gross as Chief Commercial Officer.
Press release about expanding government collaborations.
Press release about a new contract supporting NIDAS clinical trials network.
Article about Emmes' submission for Duchenne disease.
Press release about leadership change at Veridix.
Press release about the formation of Emmes Group.