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SUCCESSES
Trio has extensive therapeutic experience due to our network. We are not limited by therapeutic areas. Often when companies site “experience”, they are actually referring to the remains at that company from the historical experience of those projects. |
Case Study #1 - The Rescue
Client Need: On a Pivotal Phase III COPD program the existing CROs monitoring team needed replacement due to concern with quality of monitoring, turnover and the existing team’s inability to meet project timelines.
Results: A team of 12 therapeutically aligned, experienced CRAs were put in place for the ongoing project within 2 weeks of Trio’s notification. Trio assumed site management and monitoring for this particular study at the request of the sponsor due to the sites’ extreme level of frustration. The Trio team worked very hard to re-establish these site relationships and successfully executed a seamless transition for the sites. Unfortunately, the previous group had allotted insufficient resources to adequately monitor the sites. This had led to a CRF retrieval rate months behind schedule and monitoring that was of very poor quality. This level of quality was evidenced by the Trio CRAs identifying numerous protocol violations not previously identified and/or reported. The new team was able to recover the study, meet the planned database lock timelines and got CRF retrieval back on schedule all while improving the level of quality in the monitoring; which ultimately ended with a query rate of less than 5%. The client was very pleased with the study’s successful conclusion and continues to award work to Trio. |
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Case Study #2 - Pivotal Gastrointestinal Trial
Client Need: A site management and monitoring team, including Clinical Team Lead and CRAs to manage a 76 site Pivotal Phase III Crohn’s Disease study. The client wanted to maintain Project Management control based on their prior history with another CRO. Highly experienced (therapeutic and monitoring) CRAs were needed. Results: Enrollment goal was met two (2) weeks ahead of schedule. On-site monitoring was accomplished in 70% of projected time on site as requested by the client and the query rate was <5%. In addition, Trio was awarded the extension study. |
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Case Study #3 - Pivotal Dermatology Program
Client Need: A Project Team to manage and monitor a Pivotal Phase III Dermatology program requested by the FDA. Client had very limited internal resources. Meeting timeline expectation was critical for the company.
Results: Trio rapidly assembled a project team including a Project Manager, Regulatory Document Specialists, Clinical Support Specialists and a team of therapeutically aligned regional CRAs. In addition, Trio coordinated the selection and management of the additional service providers who addressed the client’s needs for Drug Safety, Data Management and Biostatistics. Through proactive project management and site management, enrollment goals were ahead of schedule and the client’s data are on target for meeting their FDA submission timeline. Trio was awarded three additional projects. |
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Case Study #4 - Clinical Pharmacology Site Management Team
Client Need: Client needed a flexible pool of 15 monitors to monitor their robust Phase I/IIa pipeline on an ad hoc basis.
Results: Trio provided 15 monitors with experience monitoring Phase I studies across the US and they were trained on the client’s SOPs. The sponsor works closely with Trio to coordinate this monitoring support on an as needed basis, providing monitoring services for about 75 protocols per year. The program has been so successful that an additional 15 monitors have been added to serve the need of the continued growth. |
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Case Study #5 - Rapid Safety Data Retrieval
Client Need: The FDA requested of our client additional information regarding specific cardiovascular safety parameters for events previously reported. The client needed this additional subject data retrieved, reviewed, and collected for submission to an independent review committee and ultimately to the FDA. This project was not competitively bid and was awarded to Trio due to our excellent performance on an existing study.
Results: Trio identified a team of highly experienced CRAs specifically with cardiovascular therapeutic area background within a one week timeframe. In fact, the Trio CRAs and PM were in place and ready to begin their activities quicker than the sponsor could notify the sites and coordinate the process with the independent review committee. The Trio team completed this project, which included conducting 46 on site visits, in 6 weeks. The sponsor was absolutely ecstatic with Trio’s ability to get this unexpected project completed so quickly enabling them to provide the data to the independent review committee ahead of schedule. |
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Case Study #6 - Regulatory Submission
Client Need: An ISS (Integrated Summary of Safety) needed to be prepared under a tight timeline for a resubmission of a CTD (Common Technical Document).
Results: Trio provided a team of medical writers with the specific therapeutic experience as well as experience with the Client’s template and specific writing and ICH guidelines. Other experienced writers conducted the QA on the document. One writer served as a project manager for the writing and QA processes and the single administrative contact for the client. Having several writers prepare the ISS saved time since sections could be written and reviewed concurrently. |
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