CLII Commercial Clinical Trials Unit

Commercial Clinical Trials Unit

The Commercial Clinical Trials Unit was set up specifically to assist start up and established companies to graduate their products through the various stages of the commercial pipeline. The work typically involves evaluating early commercial prototypes or undertaking clinical trials of finalised commercial prototypes. The CLII CCT undertakes work in any branch of respiratory or general medicine but is particularly focussed on devices related to pulmonology and infectious diseases. The CLII Clinical Trials Units has one-stop specialist expertise that incorporates obtaining ethical approvals, obtaining local and South African MCC regulatory approvals, and exporting samples. It also has clinical expertise in designing phase I, II and phase III studies. Statistical analysis and manuscript publication services are also provided. Thus, the Commercial Clinical Trials Unit offers a “one-stop” service for commercial companies wanting to undertake prototype evaluation or clinical trials. The UCT Lung Institute has its own clinical profiling, financial, and human resources infrastructure that is savvy in dealing with commercial contracts and IP issues. The CCT also provides comprehensive data management services and all clinical staff are GCP and GLP trained and can conduct research studies to highest ethical and regulatory standards including those benchmarked by the South African Medicines Control Council, the EMA, and the FDA. The Unit also has a globally recognised publication track record. The CCT has a well-developed recruitment network extending from Groote Schuur Hospital, to district hospitals, to level 1 primary care facilities, and to more than 100 primary care clinics in the Cape Metropole area.

Clinical trials or relevant evaluations have been undertaken in a host of diseases including tuberculosis, ventilator-associated pneumonia, community acquired pneumonia, obstructive sleep apnoea, asthma, pulmonary thromboembolic disease, pulmonary hypertension, cystic fibrosis, and breast cancer. The CCT also has access to state of the art laboratory facilities, which can undertake a host of immunological and molecular biological studies. The laboratories perform cell culture using human cells, including those from the lung, antigenic challenge experiments, can develop immunoassays, undertake antibody generation and purification, has a 9-colour cytometric capability, can undertake cell proliferation studies, ELISPOT assays, confocal microscopy, and has its own biosafety category 3 laboratory. A host of molecular biological studies can also be undertaken including real-time PCR, RNA extraction and profiling, and next generation sequencing of DNA and RNA.

Thus, in summary, the CLII CCT has a fully GCP-trained clinical and data management team, and access to an excellent recruitment and laboratory infrastructure.