Molecular Biology Clinical Research Unit
The Stellenbosch University Molecular Biology Clinical Research Unit was established in 2016 within the Division of Molecular Biology & Human Genetics, Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, at Stellenbosch University. We are an academic multi-disciplinary team of doctors, nurses, assistants, QA and coordinating personnel, led by Dr Stephanus Malherbe, chief medical officer of the unit. We perform the clinical operations for Tuberculosis Biomarker and Immunology research. We work closely with several research laboratories within the Division, such as the Immunology Research Group, which has been active in this field of research since 2002.
Our medical staff are approved for clinical trials research by the South African Health Products Regulatory Authority (formerly the Medicines Control Council) as well as the SU Health Research Ethics Committee. All staff in the team are GCP certified.
Services we offer
For both clinical trials and observational studies, we offer study participant recruitment, screening, enrolment and follow-up, including the collection of a variety of protocol-specific samples at prescribed time-points and medical observation to ensure participant well-being and safety. We offer transport to and from our study site to trial participants for all study visits.
Samples we routinely collect include blood for various immunologic laboratory tests, urine, saliva, sputum and stool. We also work closely with other medical experts to collect samples such as broncho-alveolar lavage (BAL) fluid. Routine pregnancy testing and HIV counselling and testing form part of our services.
Our clinical activities also include the collection of a variety of data; some specialized, such as data from chest Xrays and PET/CT scans. Participants are taken to the relevant facilities by our drivers, to have these procedures done.
The future vision for this unit is that it should include the clinical staff of all research groups within the Division. Currently the clinical staff of different research groups is located in various spaces on Tygerberg campus.