The Foremast Lab For Clinical Trials
Ampath Clinical Trials Division is renowned for its extensive expertise in conducting phase I to IV clinical trials across a wide array of medical fields. The division is dedicated to providing high-quality solutions for both local and international studies, supported by a comprehensive suite of specialised laboratory tests.
About Us
The Clinical Trials department operates within a vast network of facilities, providing a nationwide service across South Africa.Ampath has been involved in phase I, II, III and IV clinical trials since 1997. We offer solutions in both local and international studies. Our experience encompasses a diverse range of trials, including oncology, vaccines, neurology, trauma, and infectious disease studies. With teamwork, we provide a high-quality solution to your clinical trial needs.
We offer an extensive and specialised scope of laboratory tests, including chemistry, haematology, microbiology, flow cytometry, molecular biology, cellular immunology, TB (Biosafety level 3 TB laboratory), virology, histology, genetics and PBMC processing.
The Clinical Trials department operates within a vast network of facilities, providing a nationwide service across South Africa.
Project Management
Ampath offers end-to-end project management for clinical trials, ensuring every step—from study setup to long-term data archiving—is handled with precision and care.
Our dedicated team oversees documentation, logistics, site enablement, validation, and data quality with strict adherence to regulatory standards. With deep expertise and a proactive approach, we provide seamless coordination across stakeholders, enabling efficient trial execution and reliable outcomes you can trust.
1
Study Initiation
Quotation signed and study questionnaire sent to the client. Study file is prepared and trial, investigators, and coordinators are registered on the LIMS system.
2
Study Documentation Setup
Development of trial-specific materials including lab lists, request forms, SOPs, test order groups, reference ranges, courier instructions, and flowcharts.
3
Kit & Logistics Preparation
Kit building documents, inventory and re-order forms, shipment logs, and storage instructions are created. Initial supplies and documentation are sent to investigator sites.
4
Validation & Testing
Lab validation/test run is performed and approved by a Clinical Trials Physician. Data transfer setup and billing processes are tested and approved.
5
Site Enablement
All required documents (CVs, accreditation certificates, instruction manuals) are shared with sites. Investigator site training is offered upon request.
6
Ongoing Data Integrity Checks
100% quality checks on demographic and raw data are conducted to ensure accuracy before reports are generated.
7
Result Reporting
Laboratory reports are generated and delivered to investigator sites, sponsors, or CROs according to the agreed method.
8
Long-Term Study Management
Data is archived for 15–25 years as per client requirements, with continuous oversight by a dedicated project management team throughout the study duration.
Kit Building
Protocol, investigator and visit-specific kits
Pre-labelled blood collection tubes and request form
Transport material per kit
Resupply of kits are processed with a 5-business day turnaround time
Kit expiry date monitoring and notification
Spare supplies
Trial-specific local laboratory instruction manual
Investigator flow chart for specimen collection, handling and shipment
Laboratory courier contact list
Ampath offers comprehensive specimen management through a nationwide internal courier system and secure long-term storage at -20°C, -80°C, and -196°C.
All laboratory testing and result reporting are managed via a validated Laboratory Information System (LIS), with a 100% raw data check to ensure accuracy. Results can be delivered by telephone, email, or hard copy based on client preferences, with abnormal results flagged as specified. Electronic data transfer is also available upon request.
Another Reason to Use Ampath Clinical Trials Division
ISO 15189 Accredited
Ampath laboratories are accredited to ISO 15189:2022, by the South African National Accreditation System (SANAS).
Quality Control
Ampath has a comprehensive quality control system that ensures accurate and reliable results and complies and conform fully with the appropriate national and international quality control program requirements for all tests offered.
Internal Audits
Internal audits, performed by independent, well trained, and competent quality auditors, at regular intervals, ensures the upkeep of the quality management system in all laboratories.
Get in Contact with us
Our team is here to assist with any queries — from finding your nearest lab to getting in touch with a specific department. Reach out and we’ll make sure you get the support you need, quickly and professionally.
