FARMOVS-PAREXEL Clinical Research Organization
Acquired by PAREXEL in 2000, the Bloemfontein Clinical Pharmacology Unit was originally founded in 1975 at the University of the Orange Free State, Bloemfontein, South Africa. The Unit has successfully performed more than 1,000 Phase I-III studies.
With 90 dedicated beds, 185 highly trained staff, and a database of more than 6,700 volunteers and patients, this well-equipped facility performs ambulatory as well as stay-in trials in single- and multiple-dose regimens, including First in Man trials. In addition to a 10-bed manual Glucose Clamp Unit, specialized equipment is available for ophthalmology, plethysmography and thorough QTc studies and cardiac surveillance.
Also located at the Bloemfontein site, is one of PAREXEL's two Bioanalytical Laboratories (ISO 17025 and GLP accredited) featuring a dedicated staff of 54 and more than 500 proven validated assay methods for the quantitation of drugs and metabolites using diverse matrices with the use of state of the art LC-MS/MS intruments. Apart from a chemical analysis laboratory they also have an immunochemistry biomarker laboratory using RIA and ELISA techniques as well as a safety laboratory for clinical chemistry and hematology analysis.
The Biometrics division is able to supply statistical analysis of bioavailability data within 24 hours of receipt, along with biostatistical support of protocol and trial design, sample size estimation, and data management and coding of adverse events, concomitant illnesses, and medication. This 24-hour service is alos available as a stand-alone service accessed over a secure server for studies performed elsewhere.
Other services
- Radio isotope studies, e.g. infrared breath isotope analysis (IRIS system)
- Bone densitometry and body composition assessment, e.g. osteoporosis studies
- Respiratory with formal spiro-ergometry
- Ophthalmological safety including mrERG expertise in collaboration with US experts
- Cardiovascular studies including stable coronary artery disease, hypertension and dislipidemia
- Thorough QTc studies
- Target patient population studies, e.g. in clinical conditions including Parkinson's disease, depression, dislipidemai, HIV-AIDS, oncology and metabolic syndrome
- Hematology studies including anti-coagulants
- Degenerative diseases, e.g. arthritis
These services are supported by in-house:
- Project management
- Clinical services
- Dispensing unit
- Medical writing
- Quality management
- Independent quality assurance
Contact us
Phone: +27 51 410 3111
Fax: +27 51 444 5969
Email: clinpharmsouthafrica@parexel.com
