CGIRB Connexus® is the most advanced integrated paperless document management web portal technology serving the institutional review board (IRB) services industry. Connexus streamlines and enhances the way sponsors, CROs and investigative sites conduct the IRB submission and review process.
More than a portal, Connexus is a state of the art integrated solution that captures and manages every phase of IRB documentation. Connexus is a comprehensive tracking/audit database and e-document repository that solves the complications inherent in managing ethical review of clinical research protocols. Connexus provides clients with a completely integrated paperless solution to the entire submissions and review process from start to finish for new study submissions as well as electronic access to all legacy documents for all ongoing and open studies.
“One company – Copernicus Group IRB (CGIRB) – comes closer to epitomizing “the paperless office” in the truest sense of the term than any other company I’ve written about during my seven years covering the ECM space.” –Ken Congdon, Editor ECM Connections
Connexus is your command center for the entire IRB review process, allowing 24/7 access to manage submissions in real time. It provides study managers with unprecedented new oversight capabilities that transform the entire IRB review process. Fully FDA 21 CFR Part 11 compliant, Connexus provides a full audit trail, enabling client organizations to fulfill any regulatory demand quickly and completely in a validated environment.
The Connexus Advantage
- Conserves personnel resources: Connexus dramatically reduces the human power required to submit, update, maintain and review essential research documents.
- Increases organizational responsiveness: Connexus provides streamlined information sharing, versatile file structures and dynamic status updates, enabling your team to respond rapidly and efficiently at any time.
- Provides regulatory surety: Connexus maintains a comprehensive archive of every version of every single document and automatically establishes a meticulous audit trail.
- Protects institutional knowledge: Connexus guards against loss of organizational knowledge due to staffing changes, misplaced documents, human error or other unforeseeable circumstances.
- Enforces incomparable security: Connexus is fully validated, secure and complies with all applicable aspects of 21 CFR Part 11, ensuring that only authorized personnel can submit or access privileged files.