Vx Pharma has the capacity for trials including biosimilar and bioequivalence studies and have successfully conducted approximately 100 studiesto date. Our team has combined expertise in the following disease areas:
In response to the need by our sponsors for a higher degree of specialist therapeutic skills we are focusing our skills development and patient recruitment capabilities on a strong offering in:
HIV (Bioequivalence and Phase1b to 3)
Bioequivalence in Healthy Volunteers
Seasonal diseases such as Influenza and Allergic Rhinitis
Current Trials Open To Enrolment
As a privately owned BBBEE clinical research and site management organisation providing end-to-end clinical trials services, Vx Pharma serves the global pharmaceutical and bio-technology industries with dedicated inpatient trial services: an inpatient trials business (Vx Pharma) specialising in phase 1b and 2a (and bioequivalence) trials, as well as a collocated outpatient business (Syzygy Clinical Research Services) that focuses on Phase 3 and 4 trials.
At Vx Pharma, every trial is managed by a dedicated coordinator who is supervised by a site manager at each location. Both sites maintain the same 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 sonars, are done through our exclusive affiliation with Life Wilgers Hospital and the Intercare group.
Laboratory and Monitoring
In addition to offering a full range of routine diagnostic and screening tests at our laboratory located at our primary location, Vx Pharma has the resource 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 registered pharmacist. A constant temperature is maintained via an automated system of ambient and refrigeration equipment that also monitors the relative humidity of the pharmacy. The controlled condition keeps the study IP in a stable active state according to protocol guidelines.
Safety and security
Security at our site is strictly controlled via a biometrics 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 is 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.