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.

Highlighted features

Submission Management
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
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
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
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
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
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

AZ Sint-Jan
Zuyderland
Erasmus MC
Nutromics
Isla
Amsterdam UMC
uHasselt
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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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