SERVICES & EXPERTISE

As a fully integrated clinical trials super-site, VX Pharma offers clients highly responsive end-to-end service delivery of clinical development across all phases of drug development.

We have the capabilities & capacity to conduct trials over a broad range of disease areas ranging from bioequivalence to biosimilars and have successfully completed over 100 studies to date.

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.

PATIENT RECRUITMENT

At VX Pharma we pride ourselves on a thriving patient database, which is a direct outcome of our innovative recruitment solutions inter alia:

Direct access to treatment naïve patients via local primary care clinics
Dedicated patient enrolment function through our study coordinators
Dedicated recruitment staff in the field

PATIENT RETENTION

VX Pharma sees to it that patients stay on trials. Our successful patient retention strategy starts with effective screening and selection of suitable candidates who are likely to remain compliant. We follow through with 24/7 support ensuring patients have access to our sites at any given time of every day, enjoying the comfort of pleasant waiting rooms and fine refreshments, and having a trial investigator at their disposal at each visit. In addition, our study coordinators stay closely integrated with their trial participant community through home visits.

FOCUSED DISEASE AREAS

VX Pharma and its staff pride itself in having a diverse range of expertise suited to several areas of clinical discipline thus allowing the business to take on the challenge of a broad spectrum of clinical trials. Furthermore, we have the expertise to recruit for and complete significantly complex trials involving several co-morbidities. Our focus areas, however, are:

HIV

NOVEL THERAPIES IN HIV INCLUDING TREATMENT NAIVE PATIENTS & PAEDIATRIC PATIENTS

Cardiovascular

DYSLIPIDAEMIAS INCLUDING FAMILIAL DISORDERS

Vaccines

ABILITY TO CONDUCT TRIALS ACROSS A BROAD RANGE OF THERAPEUTIC & PREVENTATIVE VACCINE AREAS

Endocrinology

TYPE 1 & 2 DIABETES STUDIES WITH OR WITHOUT SEVERE COMPLICATIONS

Respiratory

CORE EXPERTISE IN CONDUCTING ASTHMA & COPD STUDIES IN BOTH ADULT AND PAEDIATRIC POPULATIONS WITH MODERATE TO SEVERE DISEASE

Bioequivalence

In healthy volunteers

The studies are conducted either on an inpatient or outpatient basis, depending on the protocol. For in-patient studies, our particular focus is on Phase II and bioequivalence.

Study Supervision

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.

Medical Procedures

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.

Pharmacy

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.