Clinical Trial Success Program (TSP)
Not only does a successful ePRO system have to be well-designed and technically sound, but it must also be managed expertly, supported fully, and delivered consistently to sites around the world. In order to achieve these goals, PHT has institutionalized the Trial Success Program as its best practice processes for clinical trial deployment and data management. Together with our ISO certified quality management system, TSP ensures repeatable and efficient success for every clinical trial from kickoff to closeout.
TSP in Action
TSP covers every aspect of the ePRO implementation process from requirement specification and diary design to study support and archiving.
| Step I: Study Setup | End Results |
|---|---|
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PHT assigns a dedicated project team to each trial:
PHT provides scientific and technical consulting for the protocol, requirements are established, prototypes are built and tested, diary screens are translated and validated, full validation and end to end User System Testing (UST) is conducted, and both sponsor and site personnel are fully trained. |
A validated, clean LogPad System and/or SitePad Tablet is designed and tested; sponsor and sites are fully trained Timeline6-10 weeks once the contract for work is completed |
| Step II: Study Deployment | End Results |
|---|---|
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PHT prepares and deploys the study database on our hosted central servers. Devices are prepared and shipped by our in-house Logistics department to sites around the world. Study Support Center is trained on the trial. PHT recommends a deployment date and ship times to meet FPI requirements based on in-depth experience with international shipping and customs requirements. |
Sites receive everything they need for FPI; StudyWorks is live and ready for use Timeline1 week on average; depends on the number and location of sites |
| Step III: Study Tracking | End Results |
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PHT actively manages the trial with an experienced and consistent Project Management team that stays with the study throughout its duration. Responsibilities include regular sponsor reviews, site inventory adjustments, mid-study changes, Data Clarification Forms (DCFs), enrollment and compliance monitoring, support ticket management and site performance reviews. |
Sponsors are always well informed of the trial's status TimelineTrial duration (ongoing) |
| Step IV: Study Closeout | End Results |
|---|---|
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At the trial's conclusion, PHT quickly delivers the Study Archive, and all supporting documents, to the sponsor and sites, per FDA and EMEA regulations. A final set of TSP criteria is reviewed and evaluated to close any outstanding issues. |
A successful ePRO trial with fully reconstructable data stored in XML on durable CD- and DVD-ROM media Timeline3 days - 1 month |
Learn More about TSP
How much time should we plan as first-time ePRO users? What are the critical steps on our sponsor's end to ensure an efficient deployment? Contact PHT for answers to these questions or any others you may have.
