ResearchManager Regulatory Information Management System brings structure to regulatory processes by consolidating the review and management of study applications into a single digital environment. All study data and documentation, such as protocols, informed consent forms, and amendments, are centrally managed and linked to the relevant study. This makes all information immediately accessible and easy to review, ensuring that the review process is efficient and fully traceable.

Collaboration among multiple parties presents challenges: difficulty coordinating, uncertainty about the current status, and fragmented communication. ResearchManager RIMS eliminates those challenges.

• No missed meetings: A shared calendar keeps all teams in sync with scheduled times and deadlines.
• Timely reviews: Reviewers and deadlines are directly linked to submissions, so nothing gets overlooked.
• Faster signing: Applications are signed directly in the system with a validated signature and timestamp—no detours via email.
• Always up-to-date status overview: Everyone can immediately see the status of a submission, amendment, or question.
• Less email traffic: Integrated Q&A keeps all correspondence traceable in one place; automatic notifications ensure that no one misses an action.
• Issues identified early: Dashboards provide immediate insight into pending requests and reviews, allowing the team to take proactive corrective action.

RIMS ensures that ethics committees and legally authorized representatives can demonstrate at any time that the review process was conducted correctly. Every action is automatically recorded in an audit trail in accordance with applicable laws and regulations. Access rights ensure that only authorized users can change statuses or conduct reviews.