The AddClin Research Phase I Team
Managing Director
Dr Sanet Aspinall, B MedSci, BSc Med (Hons) Microbiology, MSc Med, PhD Profile:
Dr Aspinall is the Managing Director of both Clinical Research Centres SA and AddClin Research. She works closely with Pharmaceutical companies to determine the goals for studies. Over the past few years she has been key to the launch of the Phase I study unit and trial centre in Pretoria. As the former Director for Research at the Medical University of Southern Africa, she was involved in several health research projects and clinical trials. In addition, Dr Aspinall is a member of several professional associations and has served as a member of the Medicine Control Council of South Africa.
She has acted as Principal Coordinator for several Phase 2-4 studies conducted by CRC SA and acted as Quality Assurance Manager on Phase I studies.
Responsibilities:
Dr Aspinall is involved in the following areas of AddClin Research Unit:
- Advisory capacity to the Unit and responsible for management of AddClin Research.
- Medical Writing
- Overseeing the Quality Assurance programme
- Ensuring GCP compliance
Medical Advisor and Principal Investigator
Dr Jacques Malan, MBChB, MPharm Med
Profile:
Dr Malan has extensive experience in the Pharmaceutical Industry from 1980, having worked as Principal Clinical Pharmacologist at the Medicines Control Council, as a Consultant to the Industry and as Medical Director for several companies.
Responsibilities:
Day-to-day management of all clinical studies
Training of personnel – Standard Operating Procedures and ICH Good Clinical Practice
SOP review and update
Study Designs
Medical Writing
Clinical Execution of studies
Medical Care
Chief Operational Officer and Project Manager
Mr Mark Shardelow, BA, BAA, AEA, CPR Instructor
Profile:
Mark has extensive project management experience and is currently responsible for all the operations within the unit.
Responsibilities:
- Overseeing all logistical activities within the unit
- Project Management of each studyÂ
- Ethics committee and regulatory applications
- Project Communication (liaising with all stakeholder and handling project related inquiries, as well as internal project communication)
- Assisting Business Development with preparation of study designs, budgets and cost estimates
- Updating training records
Business DevelopmentÂ
Marketing and sales
Study Designs
Study Budgets
Client liaison
Quality Assurance Officer
Ms Jané Bultman, BMedSci, BSc (Hons) Pharmacology
Profile:
Jané has previously worked at the South African Medicine Control Council in pharmacovigilance.
Responsibilities:
- Quality Assurance of all Clinical trial systems
- Review of all documentation prior to Ethics and MCC submissionÂ
Quality Control Officer  ÂMs Hanti Gunter,Â
Profile:
Hanti has previous experience  as a data coordinator
Responsibilities:
- Quality Control of all aspects before, during and after studies
- Quality Reviewing and updating Standard Operating Procedures
- Ensuring ethics and GCP compliance
Nursing Manager
Sr Lena-Marie Smith , Diploma General Nursing, Diploma Community Health, Pre- and Postnatal Care Certificate
Profile:
Sr Smith has been Lead Project Nurse for at least 30 bio-availability/bioequivalence studies, 7 Phase II/III studies, 2 Pharmacokinetic and 2 Phase II/III First Dose in Man studies and research nurse for approximately 150 Phase I bioavailability/bioequivalence studies.
Responsibilities:
Volunteer Recruitment
Clinical Execution
Study Administration
Lab Technician
Mr Benedict Ledwaba
Additional staff
The Phase I clinic contracts with a number of ICH GCP trained and experienced sub-investigators to support the PI on various studies as and when required.
Additional nursing staff, phlebotomists and a pharmacist are appointed per study on an ad hoc basis. All personnel are trained in ICH GCP and on the specific protocol before study start.
Support Functions
Mr Vernon Aspinall, BSc Ing, MBA
The unit is supported by the Finance, IT and facility manager.
The AddClin Research Phase I Team
Managing Director
Dr Sanet Aspinall, B MedSci, BSc Med (Hons) Microbiology, MSc Med, PhD Profile:
Dr Aspinall is the Managing Director of both Clinical Research Centres SA and AddClin Research. She works closely with Pharmaceutical companies to determine the goals for studies. Over the past few years she has been key to the launch of the Phase I study unit and trial centre in Pretoria. As the former Director for Research at the Medical University of Southern Africa, she was involved in several health research projects and clinical trials. In addition, Dr Aspinall is a member of several professional associations and has served as a member of the Medicine Control Council of South Africa.
She has acted as Principal Coordinator for several Phase 2-4 studies conducted by CRC SA and acted as Quality Assurance Manager on Phase I studies.
Responsibilities:
Dr Aspinall is involved in the following areas of AddClin Research Unit:
- Advisory capacity to the Unit and responsible for management of AddClin Research.
- Medical Writing
- Overseeing the Quality Assurance programme
- Ensuring GCP compliance
Medical Advisor and Principal Investigator
Dr Jacques Malan, MBChB, MPharm Med
Profile:
Dr Malan has extensive experience in the Pharmaceutical Industry from 1980, having worked as Principal Clinical Pharmacologist at the Medicines Control Council, as a Consultant to the Industry and as Medical Director for several companies.
Responsibilities:
Day-to-day management of all clinical studies
Training of personnel – Standard Operating Procedures and ICH Good Clinical Practice
SOP review and update
Study Designs
Medical Writing
Clinical Execution of studies
Medical Care
Chief Operational Officer and Project Manager
Mr Mark Shardelow, BA, BAA, AEA, CPR Instructor
Profile:
Mark has extensive project management experience and is currently responsible for all the operations within the unit.
Responsibilities:
- Overseeing all logistical activities within the unit
- Project Management of each studyÂ
- Ethics committee and regulatory applications
- Project Communication (liaising with all stakeholder and handling project related inquiries, as well as internal project communication)
- Assisting Business Development with preparation of study designs, budgets and cost estimates
- Updating training records
Business DevelopmentÂ
Marketing and sales
Study Designs
Study Budgets
Client liaison
Quality Assurance Officer
Ms Jané Bultman, BMedSci, BSc (Hons) Pharmacology
Profile:
Jané has previously worked at the South African Medicine Control Council in pharmacovigilance.
Responsibilities:
- Quality Assurance of all Clinical trial systems
- Review of all documentation prior to Ethics and MCC submissionÂ
Quality Control Officer  ÂMs Hanti Gunter,Â
Profile:
Hanti has previous experience  as a data coordinator
Responsibilities:
- Quality Control of all aspects before, during and after studies
- Quality Reviewing and updating Standard Operating Procedures
- Ensuring ethics and GCP compliance
Nursing Manager
Sr Lena-Marie Smith , Diploma General Nursing, Diploma Community Health, Pre- and Postnatal Care Certificate
Profile:
Sr Smith has been Lead Project Nurse for at least 30 bio-availability/bioequivalence studies, 7 Phase II/III studies, 2 Pharmacokinetic and 2 Phase II/III First Dose in Man studies and research nurse for approximately 150 Phase I bioavailability/bioequivalence studies.
Responsibilities:
Volunteer Recruitment
Clinical Execution
Study Administration
Lab Technician
Mr Benedict Ledwaba
Additional staff
The Phase I clinic contracts with a number of ICH GCP trained and experienced sub-investigators to support the PI on various studies as and when required.
Additional nursing staff, phlebotomists and a pharmacist are appointed per study on an ad hoc basis. All personnel are trained in ICH GCP and on the specific protocol before study start.
Support Functions
Mr Vernon Aspinall, BSc Ing, MBA
The unit is supported by the Finance, IT and facility manager.