The dawn of a new era in contract research
SITE FACILITIES
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
EMERGENCY FACILITIES
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.
CAPACITY BUILDING AT THE SITE
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.
Recent studies in HIV, infectious disease, diabetes, asthma, haematology, nephrology and dermatology gave opportunity to Specialists in the public sector to register as coinvestigators, to become involved, and gain experience in clinical research. Considering the significant cost of maintaining a private research company in South Africa, the remuneration for contract research is presently not sufficient to offer compensation to physicians while undergoing the necessary training on site. Therefore the end result is that, even though physicians are skilled in their various fields and show a keen interest in becoming involved in research, the intricacies of conducting a clinical trial and managing the regulatory requirements elude them. The combination of the inability to receive the needed approval, as well as to compensate physicians for their time and effort spent at the research site, makes it impossible to attract the necessary interest.
Phoenix Pharma takes on the responsibility of providing training to the relevant physicians in Good Clinical Practice, the finer details of the specific protocol, Clinical Case Report Completion, electronic Case Report access, etc.
In view of the above, physicians are invited to participate in clinical studies as consultants, acting within their scope of knowledge and practice. The same applies to General Practitioners from the previously disadvantaged community.
In March 2016 PHOENIX Pharma facilitated a TransCelerate Compliant GCP workshop for 33 health care workers in both the private and public sector, most of whom were from previously disadvantaged communities. For this PHOENIX Pharma obtained sponsorship from Pfizer (Inc.) South Africa. The workshop was attended by care workers from Livingstone Hospital, Provincial Hospital Port Elizabeth, Jose Pearson TB Hospital as well as the Nelson Mandela Metropolitan University. The structured workshop took participants through all stages of conducting a clinical trial, and was aimed specifically at previously disadvantaged individuals with the aid of the Missionvale Campus of the Nelson Mandela Metropolitan University.
The physicians at Phoenix Pharma do voluntary work at a local children’s Hospice since Feb 2010, where they are responsible for the examination and medical care of children with life threatening conditions. Dr D Malan is also a member of the Board of St Francis Hospice, where he also frequently gives talks on HIV/AIDS, management of pain in children, as well as Palliative Care.
The personnel at PHOENIX Pharma share knowledge about disease entities under investigation with the public, free of charge, in the form of frequent lectures, information events and small discussion groups. The expenses for these events are carried by the company, and frequently lead to free medical advice on a personal level to empower the public with knowledge. Results of investigations done at PHOENIX Pharma are duplicated free of charge, unless prohibited by study protocol, for the information of participants or treating physicians.
Patient accommodation:
The building in which PHOENIX Pharma is housed has 2 double bedrooms and 2 bathrooms, of which one is wheelchair friendly. The 4-bed ward can accommodate in-house patients for short-term stay.
24-hour medical supervision:
On-site supervision is provided by qualified registered study personnel: nursing staff trained in Basic Life Support (BLS) and research physicians trained in Advanced Cardiovascular Life Support (ACLS). A registered study investigator is on call for 24 hours in case of any emergencies. When in-house trials are being conducted, a registered nurse is on site for 24 hours for patient assistance, and for first-line emergency response.
Netcare Greenacres Hospital:
For studies where intensive safety monitoring of patients is required, PHOENIX Pharma collaborated with the Netcare Greenacres Hospital located on the corner of Cape Road and Rochelle Drive, 2,3km from the site. The area located to PHOENIX Pharma for these purposes consist of a private ward equipped for patient examination and administration of medication. There is access to a fully equipped laboratory and cold storage facilities as well as other supportr area necessary for the efficient running of trials. All standard equipment is on site, i.e. ECG machines, Baymanometers and equipped emergency trolley. PHOENIX Pharma has immediate access to the Emergency Unit, ICU and High Care facilities should this be necessary.
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
EMERGENCY FACILITIES
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.
CAPACITY BUILDING AT THE SITE
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.
Recent studies in HIV, infectious disease, diabetes, asthma, haematology, nephrology and dermatology gave opportunity to Specialists in the public sector to register as coinvestigators, to become involved, and gain experience in clinical research. Considering the significant cost of maintaining a private research company in South Africa, the remuneration for contract research is presently not sufficient to offer compensation to physicians while undergoing the necessary training on site. Therefore the end result is that, even though physicians are skilled in their various fields and show a keen interest in becoming involved in research, the intricacies of conducting a clinical trial and managing the regulatory requirements elude them. The combination of the inability to receive the needed approval, as well as to compensate physicians for their time and effort spent at the research site, makes it impossible to attract the necessary interest.
Phoenix Pharma takes on the responsibility of providing training to the relevant physicians in Good Clinical Practice, the finer details of the specific protocol, Clinical Case Report Completion, electronic Case Report access, etc.
In view of the above, physicians are invited to participate in clinical studies as consultants, acting within their scope of knowledge and practice. The same applies to General Practitioners from the previously disadvantaged community.
In March 2016 PHOENIX Pharma facilitated a TransCelerate Compliant GCP workshop for 33 health care workers in both the private and public sector, most of whom were from previously disadvantaged communities. For this PHOENIX Pharma obtained sponsorship from Pfizer (Inc.) South Africa. The workshop was attended by care workers from Livingstone Hospital, Provincial Hospital Port Elizabeth, Jose Pearson TB Hospital as well as the Nelson Mandela Metropolitan University. The structured workshop took participants through all stages of conducting a clinical trial, and was aimed specifically at previously disadvantaged individuals with the aid of the Missionvale Campus of the Nelson Mandela Metropolitan University.
The physicians at Phoenix Pharma do voluntary work at a local children’s Hospice since Feb 2010, where they are responsible for the examination and medical care of children with life threatening conditions. Dr D Malan is also a member of the Board of St Francis Hospice, where he also frequently gives talks on HIV/AIDS, management of pain in children, as well as Palliative Care.
The personnel at PHOENIX Pharma share knowledge about disease entities under investigation with the public, free of charge, in the form of frequent lectures, information events and small discussion groups. The expenses for these events are carried by the company, and frequently lead to free medical advice on a personal level to empower the public with knowledge. Results of investigations done at PHOENIX Pharma are duplicated free of charge, unless prohibited by study protocol, for the information of participants or treating physicians.
Patient accommodation:
The building in which PHOENIX Pharma is housed has 2 double bedrooms and 2 bathrooms, of which one is wheelchair friendly. The 4-bed ward can accommodate in-house patients for short-term stay.
24-hour medical supervision:
On-site supervision is provided by qualified registered study personnel: nursing staff trained in Basic Life Support (BLS) and research physicians trained in Advanced Cardiovascular Life Support (ACLS). A registered study investigator is on call for 24 hours in case of any emergencies. When in-house trials are being conducted, a registered nurse is on site for 24 hours for patient assistance, and for first-line emergency response.
Netcare Greenacres Hospital:
For studies where intensive safety monitoring of patients is required, PHOENIX Pharma collaborated with the Netcare Greenacres Hospital located on the corner of Cape Road and Rochelle Drive, 2,3km from the site. The area located to PHOENIX Pharma for these purposes consist of a private ward equipped for patient examination and administration of medication. There is access to a fully equipped laboratory and cold storage facilities as well as other supportr area necessary for the efficient running of trials. All standard equipment is on site, i.e. ECG machines, Baymanometers and equipped emergency trolley. PHOENIX Pharma has immediate access to the Emergency Unit, ICU and High Care facilities should this be necessary.