OUR TEAM HAS COMBINED EXPERTISE
VX Pharma (inclusive of Syzygy Clinical Research Services) has conducted over 150 clinical studies across a wide range of major chronic disease areas. Although we have historically embraced a broad disease-area portfolio we are embarking on a strategy to align the business to the current needs of our sponsors which now places more emphasis on specialised clinical capabilities. Our focus areas moving forward are:
The studies are done either on inpatient or outpatient basis, depending on the protocol, with particular focus on Phase IIa and bioequivalence of generic ARVs for our in- patient studies. Additionally we are looking to drive the Bioequivalence /Bioavailability study portfolio in healthy volunteers to leverage the advantages of running such studies in a well regulated yet highly price-competitive environment.
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:
a. an inpatient trials business (VX Pharma) specialising in phase Ib and IIa (and bioequivalence) trials,
b. as well as a collocated outpatient business (Syzygy Clinical Research Services) that focuses on Phase III and IV trials.
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 sonars, are done through our exclusive affiliation with Life Wilgers Hospital.
Laboratory facilities, Storage and 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 of ambient temperature and relative humidity in the pharmacy as well monitoring of the refrigeration equipment. The controlled conditions 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 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.
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