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Streamlined Trial Documentation
electronic Trial Master File
ResearchManager eTMF centralizes all clinical trial documents, including eISF, in one secure platform. Automate document tracking, alerts, and workflows to accelerate approvals, minimize errors, and maintain full compliance.
✅ Secure centralized storage
✅ Automated alerts and workflows
✅ Simplified compliance management
Reduced Storage Costs
Transitioning to digital storage with eTMF lowers expenses by 60%, eliminating the need for physical archives.
Trace Every Signature
Electronic signatures and records increase document traceability by 80%, ensuring full visibility and compliance.
Faster Audit Readiness
ResearchManager eTMF cuts audit preparation time by 50% through efficient digital document management and automatic alerts.
Key Features
Centralized Document Management
Manage all trial master files in one secure, accessible digital repository.
Flexible eTMF Document Structure
Customize document organization to fit trial needs, following standards like DIA TMF Reference Model, TransCelerate, or sponsor frameworks.
Automated Document Workflows
Streamline routing, review, and approvals to reduce errors and save time.
Advanced Filtering and Version Control
Easily filter documents and access the latest versions with full history tracking.
Dedicated eISF with External Access
Grant sites secure external access for real-time collaboration and updates.
E-Sign Functionality
Speed up approvals with compliant electronic signatures.
Audit Trail
Every action is logged: who, what, when – ensuring full traceability and compliance.
Instant Cost Estimate
Get a clear cost estimate for eTMF in under a minute.
Whether you’re preparing a single project or coordinating multiple studies, this quick estimate gives you immediate insight into expected costs.
Trusted by Researchers and Partners Worldwide
Ensuring Global Compliance and Data Security
ResearchManager Compliance Overview
- Offices in the Netherlands (HQ) and in the USA.
- ISO 27001 certified
- NEN 7510 certified
- ISO 14155 compliant
- 21 CFR PART 11 compliant
- GCP compliant
- GDPR compliant
- HIPAA compliant
- Secure connection with Comodo’s EV SSL certificate
Data Centers and Cloud Services
1) Data Centers in the EU
- TIER 3+
- SOC 2 security standards
- ISO 9001 certified
- ISO 14155 certified
- ISO 27001 certified
- NEN 7510 certified
- Dedicated backup server, AES 256 encrypted
2) Regional Cloud Services
ResearchManager offers localized cloud services in multiple regions (e.g., USA, Canada, Australia, UK, Japan), ensuring compliance with local data residency regulations.
Hans Middelweerd
Global Sales Manager - Academic & Non-Profit
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