PHASE I – IV AND BIOEQUIVALENCE TRIALS
VX Pharma offers clinical trial execution of Phase I to IV and bioequivalence studies through a business entity.
Phase I and II trials are conducted through VX Pharma (Pty) Ltd utilising our 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 tailormade patient meals. In addition, the site has patient recruitment and processing areas with dedicated consultation areas.
We are also active in the Bioequivalence/Bioavailability space in healthy volunteers, leveraging the advantages of running such studies in a well-regulated yet highly price-competitive environment.
At VX Pharma, every trial is managed by a dedicated coordinator who is supervised by a site manager. The site maintains Standard Operating Procedures (SOPs) that are compliant with GCP and cover all study aspects from start to end, including secure archiving of source data to fire compliant standards.
VX Pharma is able to provide standard medical diagnostic procedures such as ECGs, NABP, SATS monitoring and spirometry on-site at our dedicated locations. More specialised procedures, e.g. X-rays, CT scans and sonar’s, are done through our exclusive affiliation with Life Wilgers Hospital.
Laboratory facilities, Storage & Monitoring
VX Pharma is able to offer a full range of routine diagnostic and screening tests through our partners, Ampath Laboratories. We also have the resources for serum banking programs to safeguard trial samples for future reanalysis when the need arises. The site has a fully automated monitoring and control system which monitors temperature and relative humidity of relevant study zones, as well as temperatures of fridges (2°C to 8°C) and freezers (-40°C and -80°C). In addition, in compliance with GCP and GLP, our equipment is continuously calibrated to ensure accurate results.
VX Pharma operates an on-site pharmacy managed by a Responsible Pharmacist. A constant temperature is maintained via an automated system monitoring ambient temperature and relative humidity in the pharmacy as well as monitoring of the refrigeration equipment. The controlled conditions keep the study IP in a stable active state according to protocol guidelines.
PATIENT & DATA SAFETY ARE OF PARAMOUNT IMPORTANCE
Security at our site is strictly controlled via a biometric access system. We have a strong and secure information technology infrastructure. All patient source data is stored in dedicated lockable areas, including secure archiving of source data according to relevant fireproofing standards. Our electronic health records and study data are stored according to The Protection of Personal Information (POPI) Bill of South Africa. In case of a general power failure, we have a dedicated UPS-linked generator that provides backup to vital zones and equipment.
GOOD CLINICAL PRACTICE
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.