When conducting clinical research for eventual submission to the FDA, great care must be taken to utilize the most appropriate samples. Both prospective and retrospective samples can be used, but each has its own set of drawbacks and regulatory concerns. Trans-Hit Biomarkers can help you decide which path is right for your clinical and regulatory plans, as well as help you to find retrospective samples to fit your needs.
Trans-Hit Biomarkers will take care of the selection, set-up and monitoring of investigator sites when multicenter prospective studies are needed for the clinical validation of new biomarkers, maintaining high-quality standards for biospecimen sampling, shipping and storage.
Having access to a database of more than 1,500 biobanks all over the world, Trans-Hit Biomarkers has the tools to locate and select the best investigators sites for any specific disease.
For large international studies, Trans-Hit Biomarkers has established a preferred provider relationship with Covance Inc.
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| Prospective |
Designed to target specific clinical / therapeutical needs
Long time to collect
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Collects all required clinical data
|Time consuming legal/regulatory hurdles |
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Addresses intended use
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| Retrorospective |
|Collection readily available ||May or may not have all required patient data available |
| ||Samples targeted at the therapeutic area in general ||Informed consent may be restrictive, or if no informed consent is available: must need the FDA/legal requirements for use as left-over specimens |
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Addresses the intended use
The use of retrospective samples is not the right solution in every single case. However, depending upon the classification of your product within the regulatory guidelines and your intended use application, retrospective samples could potentially save you significant time and money.
Let Trans-Hit Biomakers help you determine the best path forward for your specimen, clinical and regulatory needs.
Regardless of the type of biospecimen you collect, the requirements for compliance with the regulations of the US and the rest of world are well-defined. Trans-Hit Biomarkers can assist you in defining and establishing these needs and in executing your trials. Through strategic partnerships Trans-Hit Biomarkers can assist you with all your needs, assuring total compliance and seamless integration through to completion, including all of the following:
- Clinical protocol (ICH & GCP requirements)
- IRB / IEC approvals
- Site and investigator selection
- Clinical monitoring
- Biospecimen collection and storage logistics
- Data management