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AMPATH CLImageINICAL TRIALS (ACT)  

ACT is a division within the Ampath Group which is South African based. The Ampath Pathology Laboratories were established in 1996 and practice under the registered name of Drs du Buisson, Kramer, Swart, Bouwer Inc.

ISO 15189 ACCREDITED

Our laboratories are accredited by SANAS (South African National Accreditation System) for compliance with ISO 15189 requirements, and we participate in proficiency testing to ensure quality of results.

EXPERIENCE:

Our laboratories have been involved in Phase I, II, III and IV clinical studies since 1991 with exposure to both national and international sponsor and CRO audits.

COUNTRYWIDE LABORATORY NETWORK:

Ampath has laboratories throughout South Africa and neighboring states to offer our customers full coverage of the diverse demographic and geographic entities in our country.

ACT INFRASTRUCTURE:

The reference laboratory and its support systems are located in Pretoria, within easy access of the International Airport and other countrywide transport and communication infrastructures. In addition, we are supported by an extensive internal logistical infrastructure to ensure suitable turn-around-times.

CLINICAL TRIAL MANAGEMENT:

Project Management:

  • Trial set-up, managed and coordinated by the clinical trails coordinating team.
  • Custom designed visit and site-specific Request Notes and Laboratory Kits.
  • Protocol specific Investigator Instruction Manuals.
  • Investigator meeting presentations on request.
  • On-site investigator training available upon request.
  • Courier consultation for custom designed specimen transport.
  • Trial specific Standard Operating Procedures.
  • Long-term off-site storage of all study documentation (15 years minimum).

Specimen Management:

  • Countrywide internal / external courier system available for specimen transport.
  • Long-term frozen specimen, storage: -20°C or -70°C.

Result reporting and data transfer:

  • Validated LIS system is used for all laboratory testing and result reporting.
  • Result reporting per client specification