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Project Management: |
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Trial
set-up, administered by the trial coordination manager, assisted
by a team of experts in various fields. |
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Dedicated
Project Coordination Team designated per trial. |
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Custom
designed visit and site-specific Request Notes and Laboratory
Kits. |
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Protocol
specific Investigator Instruction Manuals. |
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Investigator
meeting presentations. |
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On-site
investigator training available upon request. |
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Courier
consultation for custom designed specimen transport. |
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Validation
of patient demographic data. |
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Satellite
Laboratory training. |
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Trial
specific Standard Operating Procedures. |
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Long-term storage of all study documentation (15 years minimum). |
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Specimen
Management: |
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Countrywide internal / external courier system available for specimen
transport. |
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Timeous
delivery of specimens to countrywide laboratories. |
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Long-term
frozen specimen, PK and isolate storage: -20°C or ultra-freezing. |
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Result
reporting and data transfer: |
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Validated
LIS system is used for all laboratory testing and result reporting. |
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Telephone, fax and hard copy reporting per client specification. |
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Reporting
of abnormal results and exclusions per client specification. |