Osprey eTMF RiskManager™
Trial Master File (TMF)
Investigators/institutions and sponsors of a pharmaceutical clinical trial are required to maintain a Trial Master File (TMF), a collection of essential regulatory documents. The TMF enables scrutiny, by independent auditors and regulatory authorities, of the conduct of a trial and the quality of the data produced. These essential regulatory documents are critical to substantiate adherence to GCP standards and regulatory compliance by the trial's investigators/institutions and sponsors.
With over 50 categories of documents to track for numerous individuals spanning the three major phases of a trial, a paper-based TMF represents a tremendous financial and governance risk to all parties invested in a trial's outcome. Results of a successfully executed trial can be substantially delayed because of problems with the TMF.
Challenges with a paper-based TMF
- Extremely difficult to ensure regulatory compliance throughout all phases of a trial
- Costly and labor-intensive to manage and maintain
- Does not track the status of required document submissions or follow up action items
- Requires auditors and reviewers to access hard copies in person
- Prohibits analysis and mining of the data
- Substantially increases risk
Osprey eTMF RiskManager™ with Electronic Trial Master File
eTMF RiskManager™ is a web-based platform for collecting, managing and accessing essential regulatory documents that eliminates the challenges and risks of a paper-based TMF. Using the built-in customizable catalog of essential documents, the system can automatically solicit and track submission of all required information from individuals. Osprey eTMF RiskManager™ Smart Form technology insures that all information entered is complete and accurate - eliminating the need for manual verification. The system also supports attachment of electronic copies of forms enabling them to now be tracked automatically.
Investigators/institutions and sponsors have immediate, up-to-the-minute information available on the status of required submissions across the entire trial. Osprey eTMF RiskManager™ will automatically alert appropriate individuals should any document require follow up actions to be taken based upon customizable thresholds and conditions. Tasks are automatically assigned to track the status of the follow up action through to completion.
Independent auditors and regulatory authorities can be granted secured access to all of the essential documents of a trial and view them from any location with web access. They can use the powerful querying capabilities to quickly and easily locate documents in ways not possible with paper-based TMFs. The time required for a final close-out of a trial will be significantly reduced since verifiable compliance levels will be readily available to auditors and authorities.
Benefits of Osprey eTMF RiskManager™
- Customizable essential document catalog ensures submission of all required information
- Smart Form technology verifies documents for accuracy and completeness
- Provides real-time status reporting of compliance levels
- Automatically generates and tracks follow up action items
- Powerful querying capability enables quick and easy retrieval of essential documents
- Eliminates risks associated with paper-based TMFs
- Reliable, scalable and secure
- Customizable to fit your trial's requirements
- Documents can easily be uploaded and attached for submission
- Regulatory compliance with electronic signatures and audit trails
- Readily and securely accessible via the internet
- Advanced reporting capabilities
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