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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.
50%
Faster audit readiness
Cuts the time needed to prepare for audits through efficient digital processes.
60%
Reduced storage costs
Lowers expenses related to physical storage by transitioning to digital formats.
80%
Better traceability
Increases document traceability through digital records.
Highlighted features
Centralized Document Management
Store, organize, and manage all trial master files in a centralized digital repository, improving accessibility and collaboration.
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
Automate document routing, review, and approval workflows to enhance efficiency and reduce manual errors.
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
Provide sites with external access to their specific document sections through the eISF, enabling seamless collaboration and real-time updates.
E-Sign Functionality
Streamline document approvals with a built-in compliant electronic signature capabilities, ensuring compliance and efficiency.
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
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Discover why our users have chosen ResearchManager
All-in-one suite for every stage of clinical research
The Clinical Research Suite (CRS) is an all-in-one solution for managing Clinical Data and Operations, from trial planning to completion. CRS provides a cost-effective solution by combining multiple tools and services into one platform, reducing the need for multiple vendors.
Scalable Solutions for Organizations of All Sizes
The Clinical Research Suite scales to meet the needs of any organization. Small organizations can choose the Pay-as-you-go On Demand model, while mid-size and large organizations benefit from the Enterprise package with structured plans for multiple ongoing studies, ensuring efficient resource management and growth.
Fast-go live within 5 working days
The Clinical Research Suite (CRS) offers a fast go-live option within 5 working days. Additionally, fully customized implementations are available, tailored to specific needs, ensuring the platform aligns perfectly with trial requirements.
Dedicated team with personalized support
Experienced in-house second-line assistance and a dedicated account manager are always included to ensure seamless operations and personalized guidance throughout the entire process.
Proven success
With over 20,000 studies conducted, 8,000+ active users, and more than 1,000,000 patients enrolled, ResearchManager’s Clinical Research Suite (CRS) has a proven track record of delivering successful clinical trials worldwide.
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
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 provides localized cloud services in various regions (e.g., USA, Canada, Australia, UK, Japan), ensuring compliance with regional data residency regulations. This guarantees that data is stored and processed within the respective country’s jurisdiction, adhering to local security and compliance standards.
Saskia van Gastel
Accountmanager
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