Track Record
TTC Study Count
0
CARDIOVASCULAR
0
VACCINE
0
METABOLIC
0
HEALTHY VOLUNTEER
0
RESPIRATORY
0
RHEUMATOLOGY
0
INFECTIOUS
0
GENERAL MEDS
0
NEUROLOGY
0
DEVICE
0
GASTROENTEROLOGY
Audits
TTC has been audited and inspected 52 times since 2004.
Inspection by regulatory authorities: MCC (2007) and FDA (2005) without significant findings. TTC participated in a MCC inspection for training of WHO auditors (2014).
EXPERIENCE IN REMOTE DATA
- Medidata RAVE
- Oracle
- PhaseFoward i.e. InForm
- Perceptive i.e. DataLabs
INTERACTIVE VOICE RESPONSE SYSTEMS
- ClinPhone
- Almac
- RAMOS
- i-Perspective
- ICON
- IMPALA
PATIENT ELECTRONIC DIARIES
- Viasys (Jaeger)
- AM 2+
- AM 3+
- Biomedical Systems
- Blackberry
CLINICAL STUDY REPORTS
COMPILED FOR REGISTRATION OF MEDICATIONS IN EUROPEAN UNION AND OTHER COUNTRIES
- A Randomised Single Blind Three-Period Crossover Therapeutic Equivalence And Safety Study Of Two Salbutamol Formulations Delivered By HFA-MDI (Innovator And Generic) vs. Placebo In Adults With Chronic Stable Asthma. Protocol No Nlab 001. Neolab, UK . Principal Investigator: Dr H Nell. 2002.
- Therapeutic Equivalence Study of Inhaled Beclomethasone with CFC and non-CFC (HFA134a) propellants, both delivered by MDI, in adults with moderate asthma. Protocol No. Nlab 002. Neolab, UK. 2003-2004. Principal Investigator: Dr H Nell. 2004.
- A Double-blind Double-dummy Therapeutic Equivalence And Safety Study Of Two Formoterol Formulations Delivered By MDI (Innovator And Generic) vs Placebo In Adults With Chronic Obstructive Pulmonary Disease (COPD) Protocol No Nlab004. Neolab, UK. Principal Investigator: Prof JRJ Joubert. 2006.
- A Phase II, randomised, double-blind, double-dummy crossover study to compare the effect of two formulations of beclometasone dipropionate (hydrofluoroalkane vs chlorofluorocarbon) delivered by Metered Dose Inhaler (MDI) on methacholine hyper-reactivity in patients with mild to moderate asthma. Protocol No Nlab005. Neolab, UK. Principal Investigator: Dr H Nell. 2006.
- A randomised, double-blind, double dummy, crossover study to compare the effects on cortisol secretion of Beclometasone Dipropionate delivered by Gentle-Haler (Manufactured by Cipla Ltd, Mumbai, India) with Beclometasone Dipropionate pMDI delivered through the Volumatic® spacer (Manufactured by GSK Group, UK), each given for 1 week in healthy volunteers. Protocol No Neo001. Neolab, UK. Principal Investigator Dr DC Richter.
- A Phase II, Randomised, Double-Blind, Double-Dummy Crossover Study to Compare Two Hydrofluoroalkane-Propelled Pressurised Metered Dose Inhalers of Fluticasone Propionate on Methacholine Hyper-Reactivity in Patients with Mild to Moderate Asthma. Protocol No Neo002. Neolab, UK. Principal Investigator: Dr DC Richter
- Comparative efficacy and safety of two intranasal Mometasone furoate formulations in persistent allergic rhinitis. Protocol No Neo010. Neolab, UK. Principal Investigator. Dr H Nell 2008.
- A randomised, double-blind, single centre, crossover study to compare the effects on cortisol secretion of two formulations of fluticasone propionate-HFA delivered by pressurised metered dose inhaler and administered for 1 week in healthy volunteers. Protocol No Neo019. Neolab, UK. Principal Investigator Dr A Diacon
- Assessment of Inspiratory Flow Generated through the Low Range In-Check™ Simulating Synchro-Breathe® in Adults with Asthma and Adults with COPD. Protocol No Neo019. Neolab, UK. Principal Investigator Dr A Diacon 2008.
- Assessment of Inspiratory Flow Generated Through the Low Range In-Check™ Simulating Synchro-Breathe® in Paediatric and Adolescent Patients with Asthma. Protocol No Neo024. Neolab, UK. Principal Investigator: Dr J Vermeulen
- A double-blind, double dummy, randomised, placebo-controlled, cross-over design clinical trial of Formoterol MIAT-Haler® versus Oxis Turbuhaler® in the prevention of bronchoconstriction induced by methacholine in mild to moderate persistent asthma in adult patients. Protocol No 07-FOR-01. Andi-Ventis, Cypress and Italy. Principal Investigator: Dr H Nell
- A randomised, open-label, single centre, crossover study to compare the pharmacokinetic properties of Fluticasone in the combination Fluticasone/Salmeterol delivered by a Generic HFA pMDI (test) and the Innovator Fluticasone HFA pMDI (reference) in healthy volunteers. Protocol No Neo045 Neolab, UK. Principal Investigator D Jeannine de Bois 2009
- A Phase II, Randomised, Double-blind, Double-dummy, Three-Period Crossover Study Of Salbutamol Delivered By Metered Dose Inhaler (MDI) (Hydrofluoroalkane, HFA) via SYNCHRO-BREATHETM (SB) versus GENTLE-HALER® (GH) versus CONVENTIONAL ACTUATOR (CA) In Children With Asthma who have difficulty with coordination or the “cold Freon” effect (gagging). Protocol No Neo034. Neolab, UK. Principal Investigator: Dr J Vermeulen
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ELECTRONIC DATA TRANSFER
TCC has the capability to transmit electronic data using a dedicated analog line.
- Mortara Electrocardiogram Transfers
- Medilog Holter transfers
- MAC 1200
- Viasys Spirometry, ECG and electronic diary data
PUBLICATIONS
TTC has contributed to articles and peer-reviewed abstracts on several large studies, either in person or as a part of group of investigators
TTC has contributed to articles and peer-reviewed abstracts on several large studies, either in person or as a part of group of investigators.
Publications in person
- Tefit JN, Crabe s, Orlandini B, Nell H, Bebdelac A, Savage PB, Teyton L, Serra V. Efficacy of ABX196, a new NKT agonist, in prophylactic human vaccination. Vaccine 2014 Oct 21:32(46):6132-45
- Trummlitz 1,*, H. Nell 2, D. van Schalkwyk 3, B. Rosenkranz 4, P. Stonier 5 S- and R-Flurbiprofen Pharmacokinetics following Repeated Transdermal Medication to Healthy Subjects. The Annals of the Rheumatic Diseases 2012.
- Haylene Nell, Mirna Siebert, Pashini Chellan, Nigel Gericke. A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial of extract Sceletium tortuosum (Zembrin®) in Healthy Adults. JACM-2012-0185 .
- Carine L Clearly, Peter A Williamson, Sriram Valdeanathan, Jeannine du Bois, Haylene Nell, Brian Lipworth.Systemic Bioavailability of Hydrofluoroalkane (HFA formulations) of fluticasone/salmeterol in Healthy Volunteers via pMDI alone and spacer. Br J Clin Pharmac 69:6; 637-644;637. Jan 2010
- A,I Manjira, H Nell B Maharaj. Effect of Desloratidine on Patients with Allergic Rhinitis and Exercise-Induced Bronchoconstriction: A Placebo Controlled Study .Journal of Asthma 2009; 46, No.2; 156-159
- Daphne C Richter, James R Joubert, Haylene Nell, Mace M Schuurmans, Elvis M Irusen. Diagnostic value of post-bronchodilator pulmonary function testing to distinguish between stable, moderate to severe COPD and asthma. International Journal of COPD 2008;3(4);693-699
- Johnson Q, Syce J, Nell H, Rudeen K, Folk WR. A Randomized, Double-Blind, Placebo-Controlled Trial of Lessertia frutescens in Healthy Adults. PLoS Clinical Trials 2007; 2(4): e16.doi:10.1371/journal.pctr.0020016
- Du Toit G, Brown G, Joshua B, Motala C, Nell H, Weinberg EG. Evaluation of the bronchodilator effect and side effect profile of a salbutamol dry powder inhaler device, a prospective observational study. Current Allergy & Clinical Immunology 2003 vol16. no 3.
- Nell H, Cyster H, Williams Z, Louw C, Bardin PG, Joubert JR. Therapeutic Equivalence Study of Two Formulations of Beclometasone Dipropionate in Moderate Asthmatic Adults. S Afr Med J 2001; 91: 51-56.
- Nell H, Cyster H, Williams Z, Louw C, Bardin PG, Joubert JR. Therapeutic Equivalence Study of Two Formulations of Beclometasone Dipropionate in Moderate Asthmatic Adults. Eur Resp J 1998; 12 (Suppl 28): 64S.
- Morris CDW, Bird A, Nell H. The Haematological and Biochemical Changes in Severe Pulmonary Tuberculosis. Quart J Med 1989; 2720: 1151-1159.
- Morris CDW, Nell H. Epidemic of Pulmonary Tuberculosis in Geriatric Homes. S Afr Med J 1988; 74: 177-199.
Publication as part of study group
- The Xamterol in Severe Heart Failure Study Group. Xamterol in Severe Heart Failure. Lancet 1990; 336: 1-6.
- Efficacy and Safety of Betrixaban for extended duration tromboprophylaxis amoung ill medical patients. Apex Investigators. Poster ISTH
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