Company Profile
Tiervlei Trial Centre (TTC) is a privately owned clinical research centre. The company was founded by Prof Frans Maritz and Dr Haylene Nell in 2000. Dr Haylene Nell is Executive Head of Tiervlei Trial Centre.
Dr Haylene Nell (MB.Ch.B Hons Epid Hons Pharm) has participated in >200 clinical trials since 1988 and is experienced in medical writing, data management and biometry. She has served on the Health Research Ethics Committee, University of Stellenbosch for 5 years. Currently she co-presents the Post Graduate Diploma in Pharmaceutical Medicine Division Pharmacology with the Division of Pharmacology University of Stellenbosch. The University of Western Cape honoured Dr Nell with an appointment as Extra Ordinary Associate Professor with the South African Herbal Science and Medicines Institute. Dr Nell’s has an special interest in asthma and COPD early phase studies, as well as phytomedicines.
Prof James Joubert (MB.Ch.B; M.Med.(Int); M.D.) was Chairman of the Department of Internal Medicine, Department of Health Sciences, University of Stellenbosch from 1990 to 2001. In the period he started the respiratory drug research which still functions actively. After retirement in 2001 he maintained membership of the Tygerberg Drug Research Committee which he founded 14 years previously. From 2001 up to the present moment he acted as principle investigator at TTC. During this period a part time appointment at the Faculty of Health Science and a private practice was maintained. A research appointment at Rössing Uranium mine from 1990 – 2010 provided the only research data in Africa on the effect of radiation on workers over a period of 32 years. This data is being prepared for publication.
Dr De Vries Basson (MB.Ch.B, Mmed) is a Specialist Physician experienced in clinical trials with a special interest is cardiovascular diseases. Dr. Basson serves as Head of Internal Medicine at Karl Bremer and contract Principal Investigator at TTC. In this role, he oversees the department of Internal Medicine and also forms a link between the hospital and TTC. He is also very active in the pre and post graduate educational programmes of the University of Stellenbosch,. Dr. Basson provides over 7 years of clinical research and 7 years as a specialist physician. He has taken part in many studies of which he was asked to represent South African Prevail investigators at the International Stroke Congress in San Francisco in 2007. Dr Basson completed his pre graduate studies in 1996 and postgraduate training 2003, both at the University of Stellenbosch in. He has been Head of Internal Medicine at Karl Bremer Hospital since July 2005.
Dr Matty Pretorius (MB.Ch.B) Dr Pretorius is a General Physician with more than 10 Years experience in clinical research. She is part of the Tiervlei Trial Centre since 2000 where her role is Principle Investigator for numerous international clinical trials. She is a trained echocardiographer and has 12 years experience in adult and peadiatric echocardiology. Dr Pretorius got her MB.Ch.B qualification at the University of Stellenbosch.
Prior to working at TTC she worked as an echocardiographer at the department of Cardiology at the Tygerberg Hospital. Her areas of interest are cardiovascular studies, but she has also recently started with clinical trials in the Otorhinolaryngology field at TTC, in collaboration with Dr Johan Nell otolaryngologist.
Dr Mirna Siebert (MB.Ch.B) is a general physician with 8 years experience in clinical trials. She serves as a Principal Investigator for international pharmaceutical clinical trials and has a special interest in the field of Diabetes. She is part time employed by the University of Stellenbosch and has been part of the TB research team for the past 12 years. Prior to her involvement in clinical research, she worked as a general practitioner in Namibia.
Dr Jeanne Nel (MB.Ch.B) She joined TTC as Investigator in 2010. Dr Nel has distinguished herself as Sub Investigator on more than 5 studies and will in future take on studies as Principal Investigator.
Other contract Investigators:
Dr Zirkia Joubert (MB.Ch.B, Mmed)
Administrative Team Leader Faldelah Allie-Duminy is responsible for driving and managing all aspects of business operations and provides leadership to the organization to ensure corporate objectives are achieved. In her role she is responsible for Regulatory aspects, Business Administration, Human Resources and Information Technology. She serves as liaison between staff and management for company-wide HR communication. Faldelah holds a Bachelors of Arts degree in Psychology from University of the Western Cape. She also obtained a certificate in Business Management from the University of South Africa.
Johan Heyns (BA,LLB,ND. Personnel Management) is responsible for Human Resource Management and Labour Relations. He has 17 years practical experience in the above mentioned field and acted as legal and Human Resource representative for various small to medium enterprises. He obtained higher certificates from the Institute of Administration and Commerce for Management, Labour Relations and Marketing Management. He is a chartered Personnel Practitioner and admitted advocate of the High court of the Western Cape.
Brendan Jegels is responsible for all the financial functions of the organization which includes management reporting, expenditure and revenue accounting. He has qualified as a Commercial & Financial Accountant, and holds a Bachelor of Accounting Science degree from the University of South Africa in Pretoria and a Diploma in Accounting from the Cape Peninsula University if Technology.
Christo Fourie (Hons.B.Acc, Chartered Accountant(SA), CIA) is the business consultant at Tiervlei Trial Centre. He has 34 years experience in business and financial consultancy services, external auditing, internal auditing, financial management, accounting and business process re-engineering. He is the CEO of Cape Town Data CC, the business we use to do our data management.
The trained and experienced team consists of co-investigators, research nurses, clinical trial technicians, pulmonary technicians, data entry personnel administrators, and teams for project management and patient recruitment
Training and Development Coordinator Sr Ezmey Gopal (B Tech degree: Occupational Health) (Diploma: General, Community, Midwifery and Psychiatric nursing) is responsible for operational training according to ICH-GCP (International certification of good clinical practice) a full set of TTC Working Practices. She has coordinated > 20 studies since 2006 and was appointed Coordinator Team Leader 2007 and Training and development Coordinator 2009. She worked at Tygerberg hospital as the Asthma Educator, Occupational health sister and various other specialist clinics for most of her career. She then explored other avenues in the Health sector such as Managed Health Care - Sanlam Health/Medscheme, Provincial Coordinator HIV/AIDS at SACTWU/ Clothing Industry, Case Manager at Tygerberg hospital and Project Manager University of Stellenbosch Desmond Tutu TB centre for Educational Tools Study.
Sr Carine Tredoux (Bcur Degree in Nursing) is a qualified nursing sister, working as study coordinator at TTC for the last 3 years and has coordinated more than 10 clinical trials. Before her involvement in clinical research she worked as registered nurse at Louis Leipoldt hospital for 5 years and as Team Leader at Sanlam Health Medscheme. She also worked as a Case Manager at Medscheme and Kuilsriver Hospital.
Marian Poynton (Diploma in General Nursing and Midwifery) is a qualified nursing sister, working as a study coordinator at TTC for the last 10 years and has coordinated more than 30 clinical trials.
Sr. E Nelson (Diploma in General Nursing and Midwifery) has been involved in clinical trials since 2001. She has been with Tiervlei Trail Centre since 2001, employed as a Study Coordinator and completed over 20 clinical studies.
Mrs Annalize Rosslee (BTech Clinical Technology) is a Clinical technologist ( Pulmonology). She’s been involved in clinical trials since 1997. She has been with Tiervlei trial centre since Jun 2004, employed as a study coordinator/ lungfunction technologist and has coordinated > 20 predominantly doing respiratory studies.
Mrs Anlé Nel (BTech in Clinical technology) has been involved in clinical trials since 2007, primarily Respiratory studies, Asthma & COPD. She has been with Tiervlei Trial Centre since Apr 2009, employed as a Study coordinator/ Lungfunction technologist and has coordinated > 10 clinical trials.
Ms Lelanie Haak (BTech in Clinical technology) ) has been involved in clinical trials since 2007, primarily Respiratory studies, Asthma & COPD. She has been with Tiervlei Trial Centre since Apr 2009, employed as a Study coordinator/ Lungfunction technologist and has coordinated > 10 clinical trials.
Mrs Pashini Chellan (BPharm) is a Pharmacist with 7 years experience in clinical trials, having worked as a CRA on Cardiovascular and Oncology studies and then as a Regulatory Pharmacist specialising in New Product Registrations as well as Clinical Trial Regulatory Applications. She joined TTC in April 2010 to assist with the dispensing of Investigational Products.
TTC has successfully participated in over 200 international clinical trials in various therapeutic areas.
Total Number of studies: 223
Pulmonology |
Asthma |
38 |
|
COPD |
30 |
||
Allergic Rhinitis |
4 |
||
Pulmonary Arterial Hypertension |
1 |
||
Pulmonary Fibrosis |
1 |
74 |
|
Cardiovascular |
Hypertension |
10 |
|
Acute Coronary Syndrome |
5 |
||
Myocardial Infarct |
4 |
||
Stable Angina |
2 |
||
Atrial Fibrillation |
8 |
||
CVS Risk |
10 |
||
Heart Failure |
3 |
||
Cerebro Vascular accident |
9 |
||
Deep venous thrombosis |
6 |
||
Peripheral Arterial Disease |
1 |
||
Pulmonary Embolus |
2 |
60 |
|
Metabolic |
Dyspipidemia |
8 |
|
Familial Hypercholesterolemia |
4 |
||
Type 2 Diabetes |
28 |
||
Diabetes Insulin dependent |
2 |
||
Obesity |
1 |
43 |
|
Infectious |
Hospital Acquired Pneumonia |
3 |
|
Community Acquired Pneumonia |
2 |
||
Skin and skin structure infections |
7 |
||
HIV |
6 |
||
Tuberculosis |
6 |
24 |
|
Phase 1 |
Bio-Equivalence |
10 |
|
Phytotherapy |
2 |
12 |
|
General |
Tinnitus |
2 |
|
Osteo Arthritis |
2 |
||
Epilepsy |
2 |
||
Pain |
2 |
||
Hyponatremia |
2 |
10 |
Tiervlei Trial Centre in collaboration of Cape Town Data provides the full spectrum of services including medical writing, data management and biometry. We have successfully completed 15 full service studies.
Audits
TTC received 24 Study Audits since 2004:
- 20 Sponsor Audits
- 2 FDA Audit
- 1 MCC Audit
- 1 WHO Audit
Experience in Remote Data Capturing
Medidata RAVE
Oracle
PhaseFoward i.e. InForm
Perceptive i.e. DataLabs
Experience in patient electronic diaries
Viasys (Jaeger)
AM 2+
AM 3+
Biomedical Systems
Blackberry
Experience with electronic data transfer
TCC has the capability to transmit electronic data using a dedicated analog line. We have experience in:
Mortara Electrocardiogram Transfers
Medilog Holter transfers
MAC 1200
Viasys Spirometry, ECG and electronic diary data
Interactive Voice Response Systems
ClinPhone
Almac
RAMOS
i-Perspective
ICON
IMPALA
