Highly rated by customers | 4.2 / 5 stars

eTMF software for clinical research

ResearchManager eTMF supports secure and structured digital documentation within clinical research. With integrated eISF functionality and validated electronic signatures, documents are digitally signed, automatically archived and stored fully traceable.

Up to 60% lower storage costs through digital documentation
Up to 80% better traceability of documents and signatures
Up to 50% faster audit preparation

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Fully compliant with relevant laws and regulations

Flexible eTMF tailored to each study design

ResearchManager eTMF can be set up flexibly per study type. The document structure is set up according to the CDISC TMF Reference Model or fully customized to specific study needs. As a result, the eTMF seamlessly aligns with sponsor or CRO guidelines, without fixed or restrictive templates.

Workflows, validated eSignatures and archiving

Documents are managed through structured workflows with clear roles and responsibilities. Validated electronic signatures enable digital approval in compliance with applicable regulations. After signing, documents are automatically archived, including version control, retention periods and a full audit trail. This results in a transparent, fully traceable and inspection-ready document process.

Integrated eISF with access for external sites.

Research sites gain access to their own digital Investigator Site File within the same environment. Sites can independently upload, manage and sign documents, while sponsors maintain real-time visibility into document status by site. This reduces email traffic, speeds document exchange and increases control over site-specific documentation.

eTMF as Momentum Leader

ResearchManager CTMS/eTMF has been recognized by users as a Momentum Leader on G2, a fast-growing and highly acclaimed solution within clinical research.

Key Features

Configurable TMF structure

Support for the CDISC TMF Reference Model.
Freely configurable document structure per study
Suitable for sponsorship, CRO and academic studies
Configurable document categories and metadata by protocol
Version management and retention periods by document type
Real-time visibility into document completeness

Controlled collaboration and document flow

Structured workflows with clear division of roles
Validated electronic signatures
Automatic archiving after signing
Integrated eISF per site.
Controlled access for external research centers
Upload, management and digital signing by sites
Real-time visibility into document status per site

Compliance, security & integrations

Role-based access rights
Support for Single Sign-On (SSO)
Two-factor authentication
Validated electronic signatures
Full audit trail of all actions
Compliant with FDA 21 CFR Part 11 and ICH-GCP
Secure data storage in compliance with ISO 27001, GDPR, HIPAA, and NHS Data Security & Protection Toolkit
Import and export capabilities in various formats
REST API for reading and writing data

Trusted by 200+ organizations

For more than 13 years, CROs, sponsors, universities and healthcare organizations have relied on Clinical Research Suite every day for structured and reliable clinical research. Find out how we help organizations conduct studies more efficiently, compliantly and with complete control.

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