RIMS

Regulatory and ethics review management for clinical research, centralizing submissions, decisions, and compliance documentation.

Overview

ResearchManager RIMS is a regulatory information management system designed for ethics committees, legal representatives, and clinical research organisations. It supports the full management of regulatory and ethical review processes within clinical research, centralising submissions, decision-making, and communication between all involved parties.

RIMS is part of the ResearchManager Clinical Research Suite and is used by CROs, sponsors, universities, and healthcare institutions. The system is certified to ISO 27001 and NEN 7510, and is compliant with GCP, GDPR, FDA 21 CFR Part 11, ICH-GCP, and HIPAA requirements.

Centralised Submission and Review

Central registration of study applications
Structured submission of protocols and attachments
Support for amendments and resubmissions
Dossier management per study or application
Digital review and recording of decisions
All documentation, including protocols and informed consent forms, is centrally managed and linked to the relevant study
Decisions and conditions are recorded digitally with a full audit trail

Support for Legal Representatives

Controlled access to relevant dossiers with clearly defined roles and responsibilities
Documents can be reviewed and signed digitally using validated electronic signatures
Full documentation of the approval process is maintained throughout

Transparent Decision-Making and Follow-Up

Digital recording of decisions, conditions, and comments
Workflow management per review phase
Automatic notifications and deadline monitoring
Controlled access for legal representatives
Real-time dashboard providing an overview of the status of applications, amendments, and ongoing reviews

Compliance, Security, and Integrations

Role-based access rights
Single Sign-On (SSO) support
Two-factor authentication
Validated electronic signatures
Full audit trail of all actions
Compliant with FDA 21 CFR Part 11 and ICH-GCP
Secure data storage in accordance with ISO 27001, GDPR, and HIPAA
Import and export capabilities in multiple formats
REST API for reading and writing data

RIMS is available as part of the broader ResearchManager Clinical Research Suite, which also includes modules for EDC, CTMS, eTMF, eConsent, ePRO, and patient recruitment. The platform has been in use for over 13 years across academic, healthcare, CRO, and sponsor organisations.