Welcome to FARMOVS

We offer a wide range of services for clinical drug development

ANDA BE studies at low cost
505 b2 strategic and regulatory support in addition to HV and patient studies
Inhaled generic studies
Biosimilar studies
BE studies in patients
BE studies in ethnic populations

FARMOVS

BLOEMFONTEIN CLINICAL UNIT

Unit OverviewUNIT OVERVIEW
  • FARMOVS Clinical Research Unit is an 88-bed, full service clinical research unit.

  • Located on the campus of the University of the Free State in Bloemfontein, South Africa.

  • Quick access to nearby private and academic hospitals.

  • Over the past five years:
    – 95 studies conducted including 80 BE/BA studies.
    – over 3,500 healthy volunteers and patients enrolled.

FeaturesFEATURES
  • Our Bio-analytical Services Division (BASD) is an ISO 17025 accredited and Good Laboratory Practice compliant bio-analytical laboratory.

  • Over 500 validated assay methods; liquid chromatography with tandem mass spectrometry and high-performance liquid chromatography for small molecules, and radioimmunoassay and enzyme-linked immunosorbent assay for macromolecules; high sensitivity analysis to assist dermatology/respiratory studies.

  • Analysis of 120,000 samples per year – more than 30% comes from contract research organisations outside the South African borders.

CapabilitiesCAPABILITIES
  • Bio-equivalence/bio-availability – especially niche bio-equivalence studies, including post-menopausal females and certain patient populations.

  • Pharmaceutical services – registered as a hospital pharmacy; preparation, packing and labeling of investigational medical products (IMPs); handling of controlled substances; storage and distribution depot of IMPs for multicenter Phase I – IV studies countrywide.

  • Other capabilities – manual euglycemic clamp; large groups of up to 60 subjects enrolled per week; patients with renal impairment. Access to expert consultants including:
    – consulting psychiatrists for schizophrenia studies
    – consulting neurologists for Parkinson’s disease studies
    – consulting ophthalmologists for eye examinations
    – consulting urologist for prostate examinations

  • Therapeutic areas – respiratory, neurology/psychiatry, endocrine/metabolic, dermatology.

Recent SuccessRECENT SUCCESS
  • Parkinson’s disease – enrolled 30 patients in 3 months

  • Fast recruitment and enrollment – 380 healthy subjects for five different device studies in 3 months