Clinical Trials
Clinical Trials Laboratory
Project Management
The Wits-DIH Clinical Trial Project Team has been a dedicated partner in the clinical trial field for three decades, supporting clinical testing for samples from countries across Africa, including Ghana, Kenya, Malawi, Uganda, Tanzania, Rwanda, and Botswana, among others. With over 1,500 managed projects—including clinical trials and research and development initiatives—the team’s achievements are grounded in resilience, accountability, expertise, responsiveness, and a commitment to exceeding client expectations.
Since 2005, the Wits-DIH Clinical Trial Project Team has specialised in establishing clinical trial studies, working closely with sponsors to identify, address, and prevent protocol deviations while aligning with sponsor requirements. The team also offers logistical support in sample management and reagent allocation to Clinical Research Sites (CRCs), further strengthening research processes.
The Wits-DIH team remains a beacon of service excellence, continuously advancing quality improvement and applying complex problem-solving skills to ensure client-centred high-quality services.
The Wits-DIH Advantage: Quality-Driven Excellence in Clinical Trial Support
The Wits-DIH team is committed to service excellence, continuously advancing quality improvement, and applying complex problem-solving skills to provide high-quality, client-centred services.
Our Services Include:
- Custom Solutions: Tailored services in storage, diagnostic testing, and study planning to meet your specific needs.
- High-Quality Results: Accurate results with fast turnaround times, supported by advanced systems like LDMS for precise data management and sample tracking.
- Expert Support: Our Clinical Trial and Project Management team assists with study planning and execution, ensuring seamless alignment with your specifications.
- Biospecimen Management: Comprehensive biospecimen and biological sample management solutions to accelerate your scientific advancements.
Comprehensive Expertise
Wits-DIH offers a wide range of services, including clinical pathology assays, TB diagnostics, biomaterials storage, PBMC processing, coordination, and quality assurance. We have provided laboratory support for over 900 clinical trials, consistently meeting Good Clinical Practice (GCP) standards.
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Quality Statement
Standard of Service and Commitment to Quality
The Wits Diagnostic Innovation’s laboratories, aim to build client and stakeholder confidence through provision of quality diagnostic testing services at competitive cost. The management and laboratory personnel are committed to implementing, maintaining and continuously improving a Management System that meets the needs and requirements of users, current ISO 15189 standard, GCLP and SANAS accreditation requirements.
To this end, the laboratory management and staff uphold impartiality, confidentiality, adhere to reliable professional practice, and undertake a risk-based approach to the provision of services. This ensures the consistent provision of accurate, reliable, timely and cost-effective diagnostic testing services for our laboratory.
The Wits DIH management commits to provision of adequate resources that ensure testing is carried out by qualified and competent personnel using validated methods. The Laboratory endeavours to continually improve the management system by identifying and addressing risks and opportunities for improvement through regular review of laboratory data, evaluation of performance against established quality objectives, and through feedback received through user and personnel feedback. Identified potential and real system deficiencies are systematically addressed through the risk and non – conformity management processes.
| a. Accreditation | b. Accreditation by: |
| c. ISO 15189 | d. South African National Accreditation System (SANAS) |
| e. GCLP | f. British Qualogy Group |
| g. IATA certified- CLS repository | h. International Aviation Transport Academy |
| i. LDMS certified- CLS repository | j. Frontier Science Foundation |
| k. Quality management | l. CAP, UKNEQAS, NHLS, SMARTSPOT, IBBL |
| m. Biobanking | n. Ethics of Approval (Certificate) |
Safety Laboratory
At the Wits Diagnostic Innovation Hub, our Safety Laboratory combines manual techniques with advanced FDA-approved automated testing to uphold the highest quality standards. We maintain rigorous quality control, with daily, weekly, and monthly monitoring of internal quality control (IQC) processes to ensure continual evaluation and improvement.
Specializing in clinical trial samples, our laboratory meets both national and international accreditation standards and participates in multiple local and international External Quality Assessment (EQA) programs. We operate dedicated areas for a wide range of clinical assays, including Haematology, Chemistry, Immunochemistry, and Serology.
Trust Wits DIH to provide precise, reliable results while upholding the highest safety and quality standards for your clinical research needs.
Molecular Laboratory
The Molecular Laboratory at Wits Diagnostic Innovation Hub, established under the iLEAD program, is dedicated to processing specimens from across Africa. Equipped with modern technology, the lab handles over a thousand specimens monthly and offers advanced testing options, including:
- Xpert HIV-1 Viral Load (VL) on whole blood
- Roche cobas6800 for PCR
- Xpert HIV-1 VL verification and EQA
- SARS-CoV-2 PCR testing
Our laboratory also specialises in test development, evaluation, and preparation of quality control panels. With a team of professional staff available to assist with all molecular procedures, we ensure the highest standards of quality in molecular research. Trust Wits DIH for reliable and innovative molecular diagnostics.
TB Laboratory
The TB/Molecular Laboratory is a fully equipped Biosafety Level 3 (BSL-3) facility designed to provide high-security handling of infectious agents and advanced diagnostic capabilities for tuberculosis (TB). The laboratory is equipped with state-of-the-art molecular and microbiological technologies, enabling the detection, characterisation, and monitoring of TB and drug-resistant strains. It offers a comprehensive range of testing services, including real-time PCR, drug susceptibility testing, and molecular epidemiology studies, to support both clinical diagnostics and cutting-edge research in the fight against tuberculosis. With its robust infrastructure, the facility is committed to advancing TB diagnostics, improving patient outcomes, and contributing to global TB research efforts.
TB Microscopy ( Auramine O and Ziehl Neelsen)
TB Culture ( MGIT/ LJ)
TB Identification testing (MPT 64 antigen)
Phenotypic Drug Susceptibility testing
MTB Nucleic acid extractions
Molecular Testing involves:
GeneXpert® Ultra MTB/RIF
GeneXpert® MTB/XDR
GenoType MTBDRplus and MTBDRsl identification and susceptibility testing (Line probe assay)
GenoType Mycobacterium CM speciation
GeneXpert® CT/NG
GeneXpert® TVAG
Cobas® 6800/8800 MTB-RIF/INH
Cobas® 6800/8800 HIV-1
BD MAX™ MDR-TB
Additionally, WITSDIH participates in various TB studies in collaboration with the TB Alliance, OTSUKA, and pharmaceutical companies, while also conducting investigator-driven research. Trust us for advanced TB diagnostics and research solutions.
PBMCs (Peripheral Blood Mononuclear Cells) Laboratory
The PBMC Laboratory at WitsDIH is a specialised facility focused on the isolation and cryopreservation of specific white blood cells that are essential for the body’s immune response. These cells include lymphocytes (T cells, B cells, NK cells), monocytes, and dendritic cells. The lab’s work supports a range of clinical and research applications, such as:
- Compound Toxicity Assessment
- Vaccine Efficacy Research
- Patient Stratification
- Biomarker Identification
- Immuno-oncology
- Rare Disease Research
- Cell and Gene Therapies
- Therapeutic Drug Monitoring
- Pharmacogenetic Research
Additional Services Provided:
- Buffy Coat Processing
- External PBMC Viability & Recovery Assessment
- PBMC Processing Training
- ELISpot Assay Processing
- This comprehensive service offering makes the WitsDIH PBMC Laboratory a critical resource for advancing immune research and supporting clinical applications.
Elispot Testing Plate Well
Malaria Microscopy and EQA
Malaria is a life-threatening but curable and preventable disease. Malaria is caused and spread by the Anopheles mosquito through mosquito bites. Malaria can be prevented by vector control and chemo-preventive measures.
The disease is endemic to 85 countries in the world, having claimed 608 000 lives in 2022. Pregnant women and children less than five are more susceptible to malaria.
The vision of the World Health Organisation (WHO) and global malaria community is to eliminate malaria in all countries and territories through deliberate actions.
The Wits Diagnostic Innovation Hub is a clinical laboratory that offers malaria microscopy proficiency testing and external quality control services to clinical labs and labs enrolled on malaria studies. The proficiency scheme helps microscopists maintain their malaria microscopy skills.
The microscopy proficiency testing scheme is conducted in line with WHO guidelines. Microscopists are graded and certified three times a year on malaria parasite detection, speciation, and quantification. Labs interested in enrolling should contact malariaeqa@witsdih.ac.za.
Biorepository
Wits DIH is a state-of-the-art facility designed to store biological samples with precision and care. Supported by advanced data management systems like the Laboratory Data Management System (LDMS), our biobank ensures that samples are preserved with their integrity intact for future research and clinical use.
Our IATA-certified staff manage safe and compliant sample shipping, providing researchers with reliable access to high-quality biological materials. Samples stored in our biorepository serve diverse research purposes, from investigating disease mechanisms and developing treatments to creating diagnostic tools.
Trust Wits DIH for secure sample storage and accurate data management that advances scientific innovation.
Capacity and Storage
Our biorepository facilities, located in Johannesburg and Cape Town, offer specialised storage and processing environments for a wide range of specimen types. With advanced storage capabilities, we maintain ambient, refrigerated (2-8°C), frozen (-15°C to -30°C), ultra-low (-80°C), and liquid nitrogen (-196°C) conditions to ensure the integrity of your samples.
Currently, we have the capacity to store over Three million specimens across these temperature ranges, with facilities equipped to handle:
- Whole Blood
- Serum and Plasma
- PBMCs
- Body Fluids
- Live Cultures
- Dried Blood Spots
- Cytology and Histology Specimens
Our biorepository is dedicated to meeting the unique needs of clinical and research projects with ambitious standards of quality and care.
All samples are tracked using electronic barcode systems integrated with LDMS and LIMS. Management reports are available in electronic format and can be exported to various databases.
DNA Biobank
Established in 2016 for the H3A project, our Molecular Lab is dedicated to ensuring high-quality DNA sample management for both local and African laboratories. We perform stringent quality checks on DNA samples prior to long-term storage and utilise advanced equipment to support a range of molecular biology applications.
Our laboratory is equipped with:
- Hamilton Robotics: For efficient and precise DNA, RNA, and protein extractions.
- Nanodrop and Qubit Systems: To provide accurate DNA quantification.
- Gel Electrophoresis: For reliable quality assessment of DNA samples.
- Illumina MiSeq: Offering Next Generation Sequencing (NGS) services at competitive rates.
Our laboratory is accredited by the Integrated Biobank of Luxembourg (IBBL), assuring that all testing meets rigorous international standards. For External Quality Assessment (EQA), we participate in IBBL programs for PBMC isolations, RNA, and DNA extractions, ensuring the highest quality and accuracy across all services
Accreditation | Accreditation by: |
ISO 15189 | South African National Accreditation System (SANAS) |
GCLP | British Qualogy Group |
IATA certified- CLS repository | International Aviation Transport Academy |
LDMS certified- CLS repository | Frontier Science Foundation |
Quality management | CAP, UKNEQAS, NHLS, SMARTSPOT, IBBL |
Biobanking | Ethics of Approval (Certificate) |
Security
The biorepository is designed to offer optimal security and specimen preservation, ensuring that your valuable samples are stored in a secure and stable environment. Key security features include:
- 24-Hour Maintenance and Security: Our facility is covered round-the-clock, with on-site security personnel ensuring continual safety.
- Biometric Access Control: Only authorized personnel can access our biorepository through biometric fingerprint and facial recognition systems.
- Temperature Monitoring and Alarms: Freezers are equipped with an email alarm system for immediate notification of any temperature fluctuations.
- Backup Systems: We have liquid nitrogen and CO₂ tanks on standby, along with an on-site generator to maintain storage conditions during power outages.
- Oxygen Monitors: Safety is enhanced with oxygen monitoring to ensure a safe working environment for our staff.
With these robust security measures, Wits DIH Biorepository provides a secure, efficient, and reliable environment for managing your specimens.
Clinical Trial Kitting Solutions
The Kits Room at Wits DIH specialises in creating customised sample collection kits designed to align with clinical trial protocols and the unique needs of each study. Our kitting services offer:
- Protocol-Specific Kits: Custom-built kits include all necessary consumables, collection devices, labels, and instructions tailored to your clinical trial protocol.
- Global Distribution: Ensuring kits are efficiently distributed to multiple sites locally and internationally, reducing the risk of delays and specimen loss.
- Cost-Effective Packaging: Combining specific project consumables into a single kit, reducing costs and enhancing sample safety during transportation.
- Unique Patient Identification: Each kit includes a patient-specific, barcoded ID, ensuring precision in sample identification and minimising risk.
Wits DIH’s kitting services provide a streamlined, customised solution that enhances clinical trial efficiency and accuracy, making research procedures smoother and more reliable.