The complexity of the drug approval process requires all providers who participate as part of the development work to deliver value by producing reliable and accurate results as well as a simplified process. Therapath’s team of study coordinators will make available current tools that will assist in managing your study and they can work to develop customized tools for specific study needs as well. In addition, the team will offer:
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The Therapath team works to simplify the process of Project development and Project execution by centralizing communication through a single, contact access point; The Project Manager.
The Project Manager will act as the liason within the company to assist the speed and effectiveness of communication between the organizations. At all times, the sponsor will have access to the neuropathology staff and the actual Study Director.
Therapath has experience processing more than 70,000 skin specimens for analysis. The Muscle and Nerve Program has received biopsy specimens from more than 100 institutions in the past year alone. The Clinical Trial Division has coordinated the delivery and processing of specimens from domestic locations and 10 international sites, The Toxicology team has completed design, development and implementation of projects working with rodent and non-human primates. The group has worked with projects that were small and focused as proof of concept as well as those studies that were larger, multisite with national and international operations.
At times, the clinical trial managers have differing levels of experience. Therapath offers:
- Designing, development and training of TFM, Study Directors, and staff for your specific project
- Assistance in ordering, storing and using ancillary supplies
- Provision of pre-labeled, bar-coded, pre-filled vials
- Access to shipping relationships for domestic and international services
- Shipping service options: ambient, cool or frozen transport, temperature monitored transport
- Expertise in coordination of customs clearance of specimen shipments
All testing activities will be performed by Therapath, LLC, under CLIA but non-GLP conditions. The activity will be conducted under the responsibility and oversight of clinical trial manager, in conjunction with the Laboratory Medical Director.
Throughout the study period, Therapath utilizes project data protection strategies which includes:
- establishing project specific work teams.
- execution of company-wide confidentiality agreements.
- utilizing secure fire safe storage of original project data, blocks and slides.
- designing accurate data reconstruction techniques
The Final report will include:
- The result interpretation summary
- specimen results (qualitative, quantitative or semi- quantitative) organized in summary data spreadsheets with supporting documentation
- staining protocol information
- documentation of unusual occurrences or results