eClinical Forum

What eClinical Forum does

eClinical Forum is a non-commercial, non-profit global organization established around 2001 and headquartered in Truro, United Kingdom, that operates as a peer-run network of over 40 organizations active in clinical research. Its membership comprises pharmaceutical companies, contract research organizations (CROs), and investigator sites, and the organization provides a non-competitive environment for collaboration across regulatory, technology, and process challenges in electronic clinical research.

The organization's core products are free regulatory compliance assessment tools. eSRA (eSource-Readiness Assessment) is a questionnaire enabling investigator sites to self-assess the readiness of their computerized systems to originate data for regulated clinical trials, grounded in regulatory documents from FDA, EMA, PMDA, CMPS, MHRA, and ICH. eCF Requirements is a set of 37 unique requirements distilled from regulatory authority documents across FDA, EMA, PMDA, NMPA, MHRA, TFDA, and ICH, updated annually. ISF (Investigator Site File) System Assessment, launched in April 2024, enables sponsors to evaluate site Trial Master File systems. Complementing these tools are industry position papers covering audit trail review, TMF archiving, and eCOA data changes, several co-published with EUCROF, SCDM, and C-Path.

The business model is membership-funded: over 40 organizations pay recurring dues that finance operations, working groups (including AI/ML, Digital Health Technologies Governance, Audit Trail Review Analytics, and Essential Metadata), and the production of member-only releases such as eCF Requirements V2025 with ICH E6(R3) mappings. Core assessment tools are distributed free of charge via direct website downloads without registration, and the organization is supported by partnerships with ACRP, JPMA, ECRIN, RQA, and others for outreach and co-developed standards.

Name

eClinical Forum

Legal name

eClinical Forum

Website

https://eclinicalforum.org

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

1–10 employees

Short description

eClinical Forum is a non-profit global peer network of 40+ pharmaceutical, CRO, and investigator-site organizations that develops free regulatory compliance assessment tools (eSRA, eCF Requirements, ISF) and position papers for electronic clinical research, funded by membership dues.

Ownership category

akta.pro rank

Product category

Clinical Research Regulatory Compliance

NAICS

Business Associations (813910)

SIC

Services-Membership Organizations (8600)

akta.pro primary industry

Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC)

akta.pro secondary industries

Site & Investigator Platforms (Site Payments, Feasibility, Activation) (HLACAOAJ), Regulatory Submissions & Clinical Content Management (eCTD/Publishing) (HLACAOAN)

Keywords

• Clinical research compliance
• Electronic data assessment
• Regulatory compliance tools
• Investigator site readiness
• Clinical trial position papers

Headquarters

HQ city

Truro

HQ country

United Kingdom

HQ region

Europe

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales

Revenue model

1. Membership fees: eClinical Forum is a non-commercial, non-profit global organization funded by membership dues from over 40 organizations active in clinical research. Membership provides access to member-only releases of documents (e.g., eCF Requirements V2025 member release) and participation in working groups and discussion forums.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

eClinical Forum is a non-profit, member-run global network that develops free regulatory compliance assessment tools and industry position papers for electronic systems used in clinical research. Its core offerings include the eCF Requirements (37 requirements distilled from FDA, EMA, PMDA, NMPA, MHRA, TFDA, and ICH documents), the eSource-Readiness Assessment (eSRA) questionnaire for investigator sites, the Investigator Site File (ISF) System Assessment for sponsors, and position papers on audit trail review and trial master file archiving. The organization is funded by membership dues from 40+ clinical research organizations and provides collaboration, working groups, and discussion forums to its member community.

Product overview

eClinical Forum is a global, non-commercial, non-profit organization providing a network of peers for collaboration in clinical research for over 25 years. The organization offers a suite of free regulatory compliance tools including the eCF Requirements (a set of 37 compliance requirements based on regulatory documents from FDA, EMA, PMDA, NMPA, MHRA, TFDA, and ICH), eSRA (eSource-Readiness Assessment) for investigator sites to self-evaluate healthcare systems readiness for clinical trials, and ISF (Investigator Site File) System Assessment for sponsors. The portfolio also includes position papers on audit trail review, TMF archiving, and AI/ML technologies. The organization maintains expert working groups including the Regulatory Expert Group (REG) and collaborates with EUCROF on various clinical research initiatives.

Differentiator

Problem solved

Functional benefit

Brands

• eSRA (eSource-Readiness Assessment): Free assessment tool for sites to self-evaluate their computerized systems for compliance with clinical research regulations
• eCF Requirements
• ISF System Assessment

Products and services

• eCF Requirements
• eSRA (eSource-Readiness Assessment) Free investigator site self-assessment tool for evaluating the readiness of healthcare systems (computerized systems) to originate data that could be used in regulated clinical trials. Based on eCF Requirements with regulatory grounding for each question. Available as Form/S for eSource and Form/F for eFile systems.
• ISF (Investigator Site File) System Assessment Free assessment tool for sponsors to evaluate if a site's Investigator Site File System (Site Trial Master System) is appropriate for holding information for regulated clinical trials. Based on eCF Requirements and regulatory authority statements.
• Audit Trail Review Position Paper Industry position paper providing best practices for meeting regulatory expectations for Audit Trail Review, including recommendations on risk-based ATR use cases and reporting criteria. Developed jointly by SCDM and eClinical Forum.
• Strategies for Implementing Audit Trail Review Position Paper
• Position Paper: Trial Master File Archiving and Decommissioning Joint EUCROF/eClinical Forum position paper with 11 key positions concerning archiving of TMF and electronic data, addressing areas where regulatory expectations are not always aligned with industry practices.
• eCF Membership Network Global member network of over 40 organizations active in clinical research, providing peer networking, collaboration, discussion forums, and access to member-only resources including eCF Requirements with ICH E6 R3 mappings.

Quantifiable outcome

• eSRA used by thousands of sites globally and many pharmaceutical sponsors and CROs since 2015 launch.
• +2 more outcomes

Named customers4 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Nine partnerships are on record, tiered core and minor.

• EUCROF (European CRO Federation)coreStrategic or Co-development PartnerJoint task force with EUCROF and the eClinical Forum produced a position paper on 'Decentralized TMF Archives and The Decommissioning Of Computerised Systems Used In Clinical Trials', with representatives from ECRIN, the ePRO consortium, Medicines for Europe, and the RQA. Also established a joint Working Group on AI/ML.
• ECRIN (European Clinical Research Infrastructure Network)minorStrategic or Co-development PartnerParticipated as representatives in the joint EUCROF/eClinical Forum task force on Archiving and Decommissioning of Computerised Systems Used in Clinical Trials.
• Medicines for EuropeminorStrategic or Co-development PartnerParticipated as representatives in the joint EUCROF/eClinical Forum task force on Archiving and Decommissioning of Computerised Systems Used in Clinical Trials.
• RQA (Research Quality Association)minorStrategic or Co-development PartnerParticipated as representatives in the joint EUCROF/eClinical Forum task force on Archiving and Decommissioning of Computerised Systems Used in Clinical Trials.
• SCDM (Society for Clinical Data Management)coreStrategic or Co-development PartnerSCDM and eClinical Forum Joint Task Force published industry position paper 'AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY'. The paper outlines risk-based use cases for audit trail review and corresponding desired reporting criteria.
• C-Path (Critical Path Institute)coreStrategic or Co-development PartnerJoint eCF/C-Path team published 'Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes' in the peer-reviewed SCDM Journal 'Digital First'.
• ACRP (Association of Clinical Research Professionals)minorStrategic or Co-development PartnerACRP partnered with eClinical Forum for a public webinar delivered to nearly 200 attendees on assessing electronic healthcare systems for originating records used in regulated clinical trials.
• JPMA (Japan Pharmaceutical Manufacturers Association)minorStrategic or Co-development PartnerThe Regulatory Expert Group released an English translation of the JPMA EDC Management Sheet v2.00, a tool by which PMDA ensures computerized systems used in clinical trials comply with relevant regulations.
• ePRO ConsortiumminorStrategic or Co-development PartnerParticipated as representatives in the joint EUCROF/eClinical Forum task force on Archiving and Decommissioning of Computerised Systems Used in Clinical Trials.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Veeva Systems: Cloud provider serving life sciences including Vault clinical and quality suites. Broad incumbent with regulatory document management and TMF capabilities overlapping eCF's compliance and archiving guidance areas.
• DIA (Drug Information Association): Large global life sciences membership organization covering regulatory, clinical, and safety topics. Broad incumbent in the same professional society space but covering a much wider portfolio beyond eCF's clinical research focus.
• Medidata Solutions: Major clinical trial technology platform (EDC, eCOA, RTSM). Broad incumbent whose commercial regulatory technology suite overlaps with the system compliance categories eCF Requirements defines.

Direct peers

• Research Quality Association (RQA): International membership organization promoting quality in clinical research. Direct peer through joint participation in EUCROF/eClinical Forum task forces and overlapping industry guidance work.
• ACRP (Association of Clinical Research Professionals): Non-profit association serving clinical research professionals with education, certification, and training. Direct peer as an active webinar partner addressing investigator site system assessments.
• TransCelerate Biopharma: Non-profit industry consortium of pharmaceutical companies developing shared clinical trial solutions and standards. Direct peer in the pharma-funded standards-setting space targeting the same sponsor/CRO audience.
• EUCROF (European CRO Federation): Federation representing CROs in Europe. Direct peer through ongoing joint task forces on TMF archiving, AI/ML, and shared member ecosystem across clinical research operations.
• Critical Path Institute (C-Path): Independent non-profit developing regulatory science and data collaboration across therapeutic areas. Direct peer through joint eCOA best practice publications and overlapping consortium-style operating model.
• Society for Clinical Research Associates (SoCRA): Non-profit membership organization for clinical research professionals offering education and certification. Direct peer serving a comparable investigator/CRA audience with adjacent regulatory training content.
• Society for Clinical Data Management (SCDM): Global non-profit professional society for clinical data management. Direct peer given joint task forces, shared publications (SCDM Journal 'Digital First'), and overlapping membership base with pharmaceutical sponsors, CROs, and sites.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/eclinical-forum-limited

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about eClinical Forum