Ethics Committees & IRBs
Regulatory Authorities
Medical Ethics Review Committees or IRBs play a crucial role in the approval and oversight of clinical research to ensure the safety and rights of participating parties. ResearchManager has provided specialized and proven tools and solutions for years to support Ethics Committees in the assessment and management of clinical research, enabling them to effectively carry out their important mission.
Efficient Review and Approval of Protocols with RIMS
ResearchManager RIMS (Regulatory Information Management System) provides Ethics Committees with an advanced tool for the efficient review and approval of research protocols and related documents. With RIMS, committees can centrally store, manage, and share documents, creating a standardized and transparent workflow for protocol review and compliance. Additionally, RIMS features include tracking approval processes and generating reports, simplifying regulatory compliance and enhancing the efficiency of Ethics Committees.
Swift Approval through Digital Signatures (eSign)
With RIMS, Ethics Committees or IRBs can leverage digital signatures (eSign) for the secure and rapid approval and management of documents. This enables committees to expedite the review and approval of documents, resulting in significant time savings and an enhanced research process. Ideal for all parties involved, it is essential for fostering seamless collaboration among various departments and stakeholders.
Data Security and Compliance with Laws and Regulations
RIMS is designed with a focus on compliance with stringent regulations and information security requirements. We ensure adherence to specific standards and ethical guidelines, which is crucial for Ethics Committees. With detailed audit trails, access control, and digital signatures, RIMS provides a solid foundation for regulatory compliance and data security. This allows committees to have confidence in full compliance with all legal requirements throughout the entire process.
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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 and flexible
The Clinical Research Suite is scalable to meet the needs of trials of any size, from small studies to large, multi-site global trials.
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.
Commonly used tool by regulatory authorities
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Saskia van Gastel
Accountmanager