Phoenix Pharma

Pharma / Medical

Johannesburg, South Africa

The site is situated at 2 Eastbourne Road, Mount Croix in Port Elizabeth, and covers an area of approximately 350 m2. The site is directly opposite the Port Elizabeth Provincial Hospital Complex and 2 kilometer from Life St George’s Private Hospital. The site consists of an access-controlled 4-bed ward, separate office for monitoring purposes, ample storage space, consulting rooms, investigator’s office, patient recreational room, wheelchair friendly bathroom facilities, pharmacy and transit laboratory.

The secure and lockable, temperature controlled pharmacy has the necessary storage facilities to manage investigational product (IP) supplies, packaging as well as space for packaging and labelling of IP. Procedures for dispensing and distribution of IP according to GCP and GMP guideline / directives are in place. All refrigerators, freezers as well as the pharmacy have 24 Hour temperature and humidity monitoring with a cell phone message and e-mail warning system.

The transit laboratory has sufficient cold storage facilities, a refrigerated centrifuge and a support area necessary for the efficient running of studies. Staff tasked with laboratory procedures are all IATA trained.

Equipment at the site includes (but is not limited to):

• Calibrated Dynamaps
• Calibrated thermometers
• Calibrated ECG machines
• Calibrated flat-bed scale
• Fully equipped emergency trolley
• Refrigerated centrifuge (calibrated)
• -20°C freezer (temperature monitored)
• -80°C freezer (temperature monitored)
• Spirometry equipment
• High speed ADSL line

PHOENIX Pharma has a fully equipped emergency trolley (‘crash cart’) with defibrillator, emergency oxygen and resuscitation board on site, stocked with medication recommended by the American Heart Association. The investigators at the site are qualified with current certification in Advanced Cardio-Life Support (ACLS), and all personnel have been trained in Basic Life Support (BLS). PHOENIX Pharma has an agreement with an emergency response group and ambulance service, as well as an agreement for admission of participants to a nearby Casualty and Emergency Facility.

For loadshedding or any other electricity supply problems the site has a generator capable of supplying the premises with the necessary power. The generator automatically starts up within seconds after interruption of the ESCOM electricity supply, and restoration of electricity supply occurs within 1 minute and 30 seconds. Notification of the interruption of municipal electricity supply happens via a telephone call from the security monitoring company, Seagate Security.

There is a pressing need to expand the database of skilled Investigators from the previously disadvantaged community in the Nelson Mandela Metropole. PHOENIX Pharma is currently the only unit in Port Elizabeth conducting early phase clinical trials. The objective of PHOENIX Pharma is therefore to increase the numbers of specialist physicians who are able to participate as Principal- and sub-Investigators in early phase clinical trials. This is underscored by the fact that clinical research has become a specialised field due to regulatory and industry specific requirements. To this end, physicians need to be appointed as Co-Investigators alongside an experienced PI, and participate in trials within the scope of their professional qualifications and expertise to gain experience.

PHOENIX Pharma is committed to building capacity in the milieu where they operate. Opportunity is continuously given to physicians in the public sector to become involved in clinical research and register as co-investigators or sub-investigators for a particular study. This is unfortunately hampered by the inability to receive provincial approval to 1) conduct studies in the Public Sector in the Eastern Cape; and 2) involve Public Sector physicians in contract research. The specific problems encountered by Phoenix Pharma in terms of Provincial approval were tabled at the NHREC meeting in Pretoria on 18 May 2016.