Phase I - IV and Bioequivalence trials
VX Pharma offers clinical trial execution of Phase I to IV and bioequivalence studies through two separate business entities.
Phase I and II trials are conducted through VX Pharma (Pty) Ltd utilising the 23-bed inpatient ward, duly set up with state-of-the-art medical and transit laboratory equipment to effectively deliver on the full spectrum of clinical trial management. The ward is fully equipped with a dedicated patient monitoring area and onsite kitchen facilities that provide tailor made patient meals. In addition the site has patient recruitment and processing areas with dedicated consultation areas. These areas are shared with Syzygy Clinical Research Services (Pty) Ltd, a 100% held subsidiary of Vx Pharma, to execute Phase III and IV studies. The shared resources of the two businesses create exceptional operational and cost synergy resulting in unprecedented value for our services.
VX Pharma endorses the principle of Good Clinical Practice (GCP) with regard to human subject protection (HSP) as regulated by the U.S. Food and Drug Administration (FDA). At all times, our prime consideration is to execute good quality services without compromising the standard of care of patients.
VX Pharma respects the dignity and rights of trial participants and is committed to safeguarding their well-being. Hence, all our clinical trial proposals for new medical entities are reviewed by a central ethics committee for approval by the South African Health Products Regulatory Agency (SAHPR), a statutory body that regulates the safety and efficacy of medicines and medical devices in South Africa.