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NanoDetection Technology, is a medical devices company that has a patented Biosensor Detection System for detecting the presence of specific genes, antibodies or pathogens within a biological or environmental sample. Integrated within NanoDetection’s detector is a patented microchip biosensor based on multiple, discrete, integrated photodiodes. |
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Clinical Trial Site Management Services |
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R & D Project (s) & Clinical Trial Management Services |
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This ‘R&D 100 Award’ winning Biochip was developed at Oak Ridge National Laboratory. With a clinical detector complete, NanoDetection is currently developing a field detector for rapid, in-the-field testing of biological and bioterrorism threats, such as Avian Flu, BVD, E. coli and anthrax.
There are three primary components to NanoDetection Technology’s Biosensor Detection System – the Biochip, the detector, and the testing cartridge. NanoDetection Technology, Oak Ridge National Laboratory, and collaborating partners have invested over $5 million in developing the Biochip, a microchip biosensor based on multiple phototransistor integrated circuits. At its most basic level, the Biochip detects light from various sources (e.g. fluorescence or luminescence emitted because of a chemical reaction caused by DNA hybridization or an antibody/antigen pairing) and converts the light into a digital signal. |
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Copyright© NanoASIA Company Limited 2008 |
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Site Initiation |
Site Monitoring |
Project Management |
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Research Site Selection & Evaluation |
Source Data Validations |
Research site liaison |
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Translation Services for Protocol, Investigator’s Brochure & Informed Consent documents |
Checking internal consistency of CRF data |
Progress & status reports |
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EC/IRB Approval |
Data query management |
Tracking CRFs & DCFs |
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Local regulatory and importation approval of study drug |
Issuing data alerts to CDM |
Medical monitoring & reporting SAEs |
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Investigator’s meetings |
Monitoring of enrollment rate & patient eligibility criteria |
Onsite support & help desk for EDC |
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Personnel Training |
Drug accountability |
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Site set-up & training for Electronic Data Capture (EDC) |
Site Monitoring |
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