Experience |
Ongoing Activities
TEACHING AND TRAINING
GCP Course for Investigators and Subinvestigators, 01.09.2011
PROJECT SUPPORT
AUDITING
INSTITUTIONAL SUPPORT
Institute for Social & Preventive Medicine, University of Zurich (ISPM ZH): Assistance in building up of quality management system
Country: Switzerland
Mandator: ISPM ZH
Ecole de Santé Public, Kinshasa: Assistance in building a clinical research center
Country: Democratic Republic of the Congo
Source of monetary support: Bill & Melinda Gates Foundation
(See www.arceau-rdc.org and ARCEAU RDC)
Hôpital Biamba Marie Mutombo, Kinshasa: Assistance in building a clinical research center
Country: Democratic Republic of the Congo
Source of monetary support: Bill & Melinda Gates Foundation
(See www.arceau-rdc.org and ARCEAU RDC)
Concluded Activities
TEACHING AND TRAINING
Monitors training: Ifakara Health Institute (IHI), Bagamoyo Research & Training Center
Country: Tanzania
Mandator: IHI
Investigators training (SwissMedic certified training): Swiss Tropical & Public Health Institute
Country: Switzerland
Source of monetary support: Swiss Tropical & Public Health Institute / course participants
Work shadowing: Hosting of trainees in the framework of the 'University Professional in Clinical Trial Practice and Management' course - developed by the Clinical Trial Unit at the University Hospital Basel.
Country: Switzerland
Source of monetary support: Swiss Tropical & Public Health Institute
Investigators training: Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou
Country: Burkina Faso
Mandator: Vienna School of Clinical Research (VSCR)
Investigators training: Cheikh Anta Diop University, Dakar
Country: Senegal
Mandator: Vienna School of Clinical Research (VSCR)
Workshop contribution: Workshop on Good Clinical Practice and conduct of clinical trials of traditional Indian medicines
Country: India
Source of monetary support: Indo Swiss Joint Research Programme
Good Clinical Practice Training: - Advanced introduction to Good clinical practice
Country: The Gambia
Mandator: European & Developing Countries Clinical Trials Partnership (EDCTP)
PROJECT SUPPORT
CPD080x: Safety evaluation of CPD-0802 in uninfected vervet monkeys (trypanocidal substance)
Preclinical toxicology in 8 animals
Country: Kenya
Sponsor: Consortium for Parasitic Drug Development (CPDD)
Activity: Onsite quality supervision during project conduct
H1N1: Dose-ranging study to evaluate immunogenicity, safety and tolerability of different formulations a swine origin A/H1N1 influenza virus vaccine
Phase II trial 600 participants
Country: Switzerland
Sponsor: Medicines for Malaria Venture (MMV)
Activity: Pre-study and study initiation visits, preparation of source documents, supervision of first study day in one center
Mal55: Susceptibility of P. falciparum from Southern Laos to artemether-lumefantrine and new chemical entities: in-vivo and in-vitro studies
Phase II trial 132 patients
Country: Tanzania
Sponsor: GSK
Activity: Long term onsite assistance to quality assurance at one center (IHI Bagamoyo Research & Training Center)
SPfL: Susceptibility of P. falciparum from Southern Laos to artemether-lumefantrine and new chemical entities: in-vivo and in-vitro studies
Phase II trial 132 patients
Country: Laos
Sponsor: Medicines for Malaria Venture (MMV)
Activity: Quality assurance visit during trial
Buruli Heat: Heat treatment of Buruli ulcer
Phase II trial 12 patients
Country: Cameroon
Sponsor: University of Heidelberg (Volkswagenstiftung)
Activity: Pre-trial quality assurance consultancy
INSTITUTIONAL SUPPORT
None
AUDITING
Pyramax 05-06 trial: Auditing of trial sites of a Phase III trial on a new drug combination against acute uncomplicated malaria
Countries: Democratic Republic of the Congo, Kenya and Mali
Sponsor: Medicines for Malaria Venture (MMV)
For further information of MedRes experience see also