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Shared workspace for clinical teams to provide Sponsors, CROs, and sites a place to share and author documentation to be used in the clinical trial and, ultimately, archived in the eTMF.
A central, controlled workspace for quality documentation with connected training management to enforce compliance with quality processes and procedures.
A centralized collaboration room for managing and defining quality documentation that can be distributed as training in the interoperable LMS.
A practical, secure, and compliant single access point for TMF documentation, supporting all essential document processes and reducing the time, costs, and risks of TMF management.
Accelerate site activation by simplifying the collection, completion, and finalization of critical regulatory documentation necessary for approval to bring a site online.
An investigator site file solution that reduces administration and improves speed and compliance for site personnel and study teams with digital investigative site binder processes.
A mobile eTMF that enables site document capture and key e-clinical workstreams anytime, anywhere—saving CRAs weeks of time processing documents.
A central collaboration workspace to author, edit, and sign/approve departmental documentation.
End-to-end document lifecycles that publish directly to the eTMF and LMS, creating cultures of inspection readiness and operational excellence.
- Expedite Document Creation & Approvals
- Enable Effective Oversight
- Forecast Approvals & Submissions
- Simplify Entire Document Lifecycles
- Automate Processes & Audit Reporting
- Improve Stakeholder Collaboration
- Seamlessly Publish to the eTMF
- Seamlessly Publish to the LMS
- Improve Quality Management
- Activate Real-Time Inspection Readiness
Electronic Content Management
- eTMF Clinical Protocols
- Study Plans Clinical
- Research Liaison
- eTMF Reports
- Site Activation
- Required Documents
- IRB/EC Documents and Submissions
- SAE/SUSAR Management, Including SUSAR Workflows, CIOMS, and Monthly Safety Review Minutes
- Site Collaboration
- Sponsor and CRO Collaboration
- Investigative Site Training
- Study Personnel Training on Protocol, Regulations, and GxP and non-GxP training
- Read and Understands for SOPs and Policy Training Certificates
- HR Finance
- Procurement R&D
- Non-Clinical CMC IT
- R&D Documents
- Communications Logs
- Correspondence and Commitments
- Clinical Study Reports Contracts, Legal, Adjudication, Non-Clinical, CMC, Finance/Procurement, HR, CSV/Validation, and Change Control
- Quality Documents Policies, SOPs, Work Instructions, and Job Aids
- Quality Management Plans
- Deviations and CAPAs
- Change Control
- Approved Vendor Lists
- Audit Plans, Audit Reports, Responses,and Corrective Action Plans