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ACT
Infrastructure |
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Our
main laboratory and its support systems are located in Arcadia,
Pretoria, in the same building as Drs Du Buisson, Bruinette
& Kramer. We are within easy access of Johannesburg International
Airport and other countrywide transport and communication infrastructures.
In addition, we are supported by an extensive internal logistical
infrastructure to ensure TAT and service requirements of clients
are met and exceeded. |
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Experience |
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The
Du Buisson practice has been involved in laboratory testing,
for clinical drug trials, since 1991. In 2001 we extended our
drug trial facilities to form Ampath Clinical Trials, a dedicated
clinical drug trial laboratory. We acquired additional state-of-the-art
equipment to improve the quantity and quality of the services
available to our clients. |
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We
have participated in global studies and have been exposed to
external sponsor audits. |
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Clinical
Trial Management |
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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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Country
wide internal / external courier system available for specimen
transport. |
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Timeous
delivery of specimens to central laboratory. |
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14-day
storage of specimens for repeat testing. |
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Long-term
storage of specimens at -20°C as well as -70°C. |
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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. |
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Electronic
data transfer available on request. |