Efficient Trial Documentation Solutions

electronic Trial Master File

eTMF is a comprehensive tool, part of our Clinical Research Suite, for streamlined document management in clinical research. Essential for centrally storing and organizing documentation, expediting signatures (with eSign functionality), and optimizing site management (with eISF). This powerful tool simplifies the workflow, improves efficiency, and ensures regulatory compliance. The result? A smooth audit and research process and increased confidence in the research trajectory.

Reliable and Efficient Document Management

ResearchManager eTMF is an essential tool for research teams, focusing on the management of essential documentation. eTMF enables the storage and management of all documents in one central location. This makes protocols, approval certificates, informed consent forms, and other essential documents easily accessible and neatly organized. A powerful aspect of eTMF is the ability to set up automatic alerts and reminders, helping teams meet deadlines and comply with required regulations. This ensures a smooth audit process, allowing research teams to confidently face inspections.

Document Signing with eSign

Document signing should be fast and straightforward, and this is achievable with the eSign functionality. Secure electronic signatures enable stakeholders to sign documents quickly and legally. This feature provides complete traceability and visibility, ensuring awareness of who, when, and where a document is signed. This streamlines workflows, accelerates approvals, and facilitates faster decision-making, enhancing the efficiency of the research process.

eISF with Real-time Reporting and Status

eISF, a component of ResearchManager eTMF, is specifically designed to optimize site management. It captures and manages essential documents at research sites, enhancing communication and without document loss. One of the powerful features of eISF is the ability for real-time reporting of the ISF status, ensuring that research teams are always aware of which documents are up-to-date and which documents require their attention.

Highlighted features

Centralized Document Management
Centralized Document Management

Store, organize, and manage all trial master files in a centralized digital repository, improving accessibility and collaboration.

Flexible eTMF Document Structure
Flexible eTMF Document Structure

Customize the eTMF document structure to fit the specific needs of your trial, allowing for adaptable and scalable organization of documents.

Automated Document Workflows
Automated Document Workflows

Automate document routing, review, and approval workflows to enhance efficiency and reduce manual errors.

Advanced Filtering and Version Control
Advanced Filtering and Version Control

Make use of filtering options by country, region, organization names, and more. Maintain document integrity with version control, ensuring access to the latest document versions while keeping a history of changes.

Dedicated eISF with External Access
Dedicated eISF with External Access

Provide sites with external access to their specific document sections through the eISF, enabling seamless collaboration and real-time updates.

E-Sign Functionality
E-Sign Functionality

Streamline document approvals with a built-in compliant electronic signature capabilities, ensuring compliance and efficiency.

Audit Trail
Audit Trail

Complete audit trail functionality to document all modifications to the data, including the user who made the change, the timestamp of the change, and a detailed description of the alteration.

Users and Partners of ResearchManager

NuSkin
ETZ
The Promise
CWZ
Invicta
Sri Ramachandra
Bergman
Santeon
Cantor BioConnect
Amsterdam UMC
Clicebo
Isla
Genetesis
AZ Sint-Jan
Nutromics
Maxima MC
Kempenhaege
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Compliance and Technical Information

ResearchManager is compliant

  • 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

Information about Our Data Centers

  • TIER 3+ data centers in the EU
  • SOC 2 security standards
  • ISO 9001 certified
  • ISO 14155 certified
  • ISO 27001 certified
  • NEN 7510 certified
  • Dedicated backup server, AES 256 encrypted
Saskia van Gastel

Saskia van Gastel

Accountmanager

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