Manage Study and Document Reliability
TrialManager
Studies related to pharmaceutical products must be conducted and managed under strict controls.
This system manages study plans, reports, and other approved documents, while also supporting the storage and management of related records and materials.
What This System Supports
- 01Creation, submission, and approval of study plans, interim reports, and final reports
- 02Creation, review, and approval of quality assurance investigation reports
- 03Management of study records, archived materials, and report outputs
- 04Management of study leaders, quality assurance personnel, and document retention personnel
Features
Key Features of the TrialManager
Creation, Submission, and Approval of Study Plans and Reports
- •Create study plans, interim reports, and final reports, including study objectives, materials, protocols, results, discussions, references, and document storage information.
- •Maintain complete revision histories, including changes made, responsible users, and approval records.
Quality Assurance Review and Approval
- •Supports audits and reviews conducted by quality assurance personnel to verify the appropriateness of study plans and related documentation.
Study Document and Record Management
- •Generate reports and document outputs for study plans and study reports.
- •Print barcode labels for identifying and managing document storage locations.
Role and Responsibility Management
- •Manage approval workflows for personnel qualification and authorization.
- •Manage responsible personnel for study planning, quality assurance, and document retention.