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Simplify Regulatory Compliance with RIMS
Regulatory Information Management System
ResearchManager RIMS streamlines regulatory document management, speeding up submissions and approvals while ensuring full compliance. Secure collaboration keeps clinical trials efficient and on track.
✅ Automated workflows
✅ Centralized document management
✅ Fully compliant & secure
Streamlined Regulatory Compliance with RIMS
ResearchManager RIMS centralizes essential clinical research documents, simplifying protocol submissions and approvals for 20% better compliance.
Boosted Stakeholder Collaboration
RIMS boosts collaboration and communication between all parties involved in clinical research. This improves document management efficiency by 25%.
Built for (Inter)national Standards
Built to meet strict regulations with digital signatures, audit trails, and role-based access, enabling 30% faster approvals through automated workflows.
Key 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
Every action is logged: who, what, when – ensuring full traceability and compliance.
Instant Cost Estimate
Get a clear cost estimate for RIMS 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
ResearchManager Compliance Overview
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.
