TEMPO™ Trial Manager

TEMPO™ Trial Manager tracks key study metrics and provides numerous standard reports, as well as powerful ad hoc reporting.

The eTMF module within TEMPO Trial Manager decreases our workload and provides us {clinical trial administrators} the opportunity to work more efficiently.
- Cheryl Shorter, Manager, Clinical Trial Administration at Clinipace Worldwide

The transparency that underlies our methods serves to instill confidence in clinical trial operations. In accessing the trial meta-data, stakeholders can see how standard operating procedures (SOPs) are/were operationalized in the trial.

The integration of all project meta-data within a single system delivers a more comprehensive picture of the overall conduct of the trial. The use of technology thus enhances quality control and project efficiency; but also makes the evidence of these artifacts easily manifest through the use of performance metrics.

The Clinipace Worldwide electronic Trial Master File (eTMF), integrated within TEMPO™ Trial Manager, provides a quality controlled end-to-end process which enables the electronic searching and viewing of TMF documentation and meta-data. All paper or electronic documentation from sponsors, subsidiaries, CROs and field-based personnel is prepared, scanned, described, stored and centralized in TEMPO™ Trial Manager where it is then available for viewing and tracking over the internet. (Once uploaded and stored in TEMPO™ Trial Manager, the actual paper documentation can be filed securely within our approved document filing room.)

The power of eTMF within TEMPO™ Trial Manager is in its secure, permission-based, Web-accessibility so the entire study team can easily locate any document or set of documents required. Searching can be done either within or across studies, sites, document category or type (general section or investigator site files), including the ability to create and run reports that organize essential documents by status, request date, received date, filed date, expiry data, required for IP release, inclusion in end-point adjudication dossier, and more.

eTMF is a powerful and scalable document management solution and a study management tool delivering clinical trial teams with centralized and accessible study documentation for CRAs, Study Managers and others to use in managing activities associated with ensuring a secure, compliant, and complete TMF.

Key Features

• Point-and-click functionality to view, create, edit, move, and/or delete folders and documents
• Role and permission-based control so only authorized staff can create, edit, move, and/or delete documents and files
• Ability to create document containers as a placeholder for documents that must be collected in the future
• Mass update function to easily update key meta-data of one or more documents
• Complete and comprehensive visibility into to investigator site file to assist with reconciliation between the TMF and site-based regulatory binder
• Role-based permissioning ensures visibility, while controlling access
• Universal meta-data management to ensure complete lifecycle management and visibility of all essential TMF documents
• Integrated TMF and investigator site file completeness reports and ad hoc reporting engine
• Advanced filtering capabilities to locate essential documents based on sponsor, study, site, category, and/or type
• TMF integrated study, site, and monitoring visit records within TEMPO™ Trial Manager to enable CRAs to view existing documents and add new documents (trip reports, etc)
• Ability to export all study-related TMF documents and copy onto a DVD
• Document versioning and complete audit trail reports