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Empowering Regulatory Compliance Effortlessly
Regulatory Information Management System
RIMS (Regulatory Information Management System) from ResearchManager consists of tools developed for effective document management in clinical research. Specifically designed for the Regulatory Affairs team, Ethics Committees, sponsors, and CROs, we have created setups that are essential for managing essential documents. RIMS is configured to simplify compliance with legal frameworks while promoting collaboration. Additionally, RIMS complies with international standards and requirements, elevating the level of a research project.
Compliance and Adherence to Legal Requirements
ResearchManager RIMS is a powerful tool supporting Regulatory Affairs teams, Ethics Committees, Sponsors, CROs, and other stakeholders in effectively managing essential documentation for clinical research. With advanced features such as the ability to submit research protocols and manage approval processes, we simplify and streamline the process while ensuring compliance with legal requirements.
Improved Collaboration
RIMS is a central and online hub within the Clinical Research Suite for sharing essential documentation and communication, enhancing collaboration among all stakeholders in clinical research. This is crucial as it is essential to continually meet the complex requirements of national and international regulations. By utilizing ResearchManager RIMS, all parties involved can collaborate effectively and efficiently, with a focus on compliance, facilitating the successful execution of clinical research at a proven faster pace.
(Inter)national Standards
ResearchManager RIMS complies with stringent (inter)national regulatory standards. Features such as digital signatures, audit trails, and secure data storage form the basis for adherence to these standards. Access based on roles and permissions, ensuring specific users have access to relevant documents, enhances information security. It is crucial to continuously meet the requirements of these standards. Users of ResearchManager can fully trust in an engaged and secure partner that complies with legal frameworks throughout the entire research process.
20%
Better compliance
Enhances regulatory compliance support through centralization.
25%
More efficiency
Increases document management efficiency with automation.
30%
Faster approvals
Speeds up approval processes through digital workflows.
Highlighted features
Submission Management
Streamline the preparation, submission, and tracking of ethics applications and amendments to ensure timely review and approval by ECs/IRBs.
Review and Approval Workflow
Automate and streamline the workflow for ethics review and approval, including notifications and reminders for reviewers and investigators, to improve efficiency and reduce turnaround times.
Document Control
Efficiently manage and control ethics-related documents, including informed consent forms, study protocols, and approval letters, ensuring secure storage and easy retrieval.
Compliance Monitoring
Maintain up-to-date records of compliance with ethical guidelines and regulations, tracking approvals, renewals, and expirations to ensure ongoing adherence.
Communication and Collaboration
Facilitate seamless communication and collaboration among ECs/IRB members, investigators, and other stakeholders, ensuring efficient information exchange and coordination throughout the ethics review process.
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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