Soweto CTC

Experience

Soweto CTC is an experienced trial site and has been involved in over 40 executed clinical trials across a range o therapeutic areas including Cardiovascular disease (Hypertension, CVS outcomes trial, dyslipidaemia, Respiratory (Asthma), Paediatrics (vaccines, hpertension), Geriatrics, Diabetes,, Infectious Diseases (Acute and Chronic), HIV, CNS, Arthritis, Urology, Substance Abuse, Pain Management and Vaccines.

All investigators at the site are experienced, with two of them having completed in excess of 40 clinical trial protocols each.

The site has an experienced and efficient principal study coordinator, who is pedantic about detail. She is the recipient of the 2010 SACRA Study Co-ordinator of the year award. There are four additional experienced full time Study Co-coordinators’ and another full time Study Co-coordinator/Data Capturer. All staff are GCP trained and have current training.

Disease areas

• HIV
• Influenza
• Mental Health
• Respiratory Diseases

Other information

The site has two components, in the same building. A medical practice (DR AE Bhorat) and a clinical trial centre (Soweto CTC). The practice is an established forty year old medical practice (one of Soweto’s oldest general practices) with patient files in excess of ten thousand. The site is situated on Chris Hani Road, which is a busy main road in Soweto, on a double stand. As such it has a large space which is solely dedicated to clinical trial work, alongside the fully functioning medical practice. The practice employs a full time locum besides the two investigators who are also full time employed on site.

The site has a locked dispensary with adequate storage space; temperature monitoring and both the investigators are licensed by the Department Of Health to dispense medication.

The site has multiple examination rooms, a procedure room, a large waiting room, receptionist’s office, a computer and office area, 2 Investigator offices, access controlled and temperature controlled dispensary, a Lab sampling and spirometry room, a Study coordinator’s room, a patient education room, a large monitor’s room, 1 other monitors room, 1 room presently unallocated, a kitchen and 3 separate toilets. There are also numerous lockable cupboards and storage space.

The practice has an average patient walk in of about sixty patients per day. The site has an ECG, a spirometry machine, an oxygen concentrator, a fully stocked emergency trolley which is checked monthly, a nebulizer, calibrated scales, a room temperature centrifuge and a refrigerated centrifuge, an ultrasound machine, a -200c fridge, two fridges (2-80c) and a generator with automatic switch over. All relevant equipment has calibration certificates which are current.

Archiving of all trial documents is done offsite at Docufile. The site has both ADSL and 3G with three desktops and two lap tops while the staff is computer literate.

The site has SOP’s in place which all staff are trained on and which are reviewed yearly.