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CLINICAL TRIAL & PRODUCT DEVELOPMENT SERVICES
TBAC has a successful track record of providing a highly standardized collection of bio-samples with top quality preservation of target integrity to a variety of clients including clinical research organizations and pharmaceutical and diagnostic companies.
TBAC facilitates large patient-based clinical trials or research and development studies involving large amounts of bio-specimens, associated research and patient data.
Beginning with specimen procurement, through analysis, storage, and data management, TBAC offers standardized methodologies for each vital step in the clinical trial process. This systems approach provides homogeneity of the process, maximizing the number of enrolled patients' data utilized throughout the trial, resulting in savings in revenue and time. TBAC offers a turnkey approach by providing the controlled methodology required for successful studies.
Support and Logistics
- Kit preparation
- Bio-specimen collection
- Bio-specimen tracking
- Label design / Bar Coding
- IATA Certified Shippers
- Sample analysis to compliment clinical findings
- Monitoring dose-escalation studies
- Identifying target responder patient populations
- Data analysis
- Reporting
- Coordinate and conduct follow-on studies
Standard Protocols
Standardized patient consent and research protocols for the procurement of bio-specimens at multiple sites that respect both HIPAA-compliant restrictions in patient privacy and FDA 21CFR-11 regulations afford accrual of clinical information adequate to optimize the research potential of specimens. This improves the quality of bio-specimens, thus broadening access to and usability of cases across sites and studies.
Analysis
Expert genetic and proteomic analysis of specimens utilizing cutting-edge technology at a single site by the experts in the respective fields assures consistency of results.
Product Development
Assistance with RUO -> ASR -> IVD utilizing a CLIA certified reference lab and the ability to access a large patient base.
Pharmaceutical Services - Drug Development
Expertise and resources to help procure or process specimens and coordinate and conduct follow-on studies and analysis to complement the clinical findings including monitoring dose escalation, identifying target responder patient populations, or a host of other analytical possibilities.
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