C L I N I C A L   T R I A L S
 
ACT Infrastructure
  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.
 
Experience
  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.
 
  We have participated in global studies and have been exposed to external sponsor audits.
 
Clinical Trial Management
  Project Management:
Trial set-up, administered by the trial coordination manager assisted by a team of experts in various fields.
Dedicated Project Coordination Team designated per trial.
Custom designed visit and site-specific Request Notes and Laboratory Kits.
Protocol specific investigator instruction manuals.
Investigator meeting presentations.
On-site investigator training available upon request.
Courier consultation for custom designed specimen transport.
Validation of patient demographic data.
Satellite Laboratory training
Trial specific Standard Operating Procedures
Long-term storage of all study documentation (15 years minimum).
   
  Specimen Management:
Country wide internal / external courier system available for specimen transport.
Timeous delivery of specimens to central laboratory.
14-day storage of specimens for repeat testing.
Long-term storage of specimens at -20°C as well as -70°C.
 
  Result reporting and data transfer:
Validated LIS system is used for all laboratory testing and result reporting.
Telephone, fax and hard copy reporting per client specification.
Reporting of abnormal results and exclusions per client specification.
Electronic data transfer available on request.
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