Medicines Research

The aim of the Department of Medicines Research (MedRes) is to effectively contribute to bridging the “translational gaps” in the R&D-process for drugs, vaccines, diagnostics and public health interventions targeted at populations in resource limited economies.

 

Within the overall mission and strategy of the Swiss TPH, MedRes sees its role in the provision of high quality services in the conduct of clinical research for the benefit of new interventions, the provision of training aspects related to clinical research and participating in research collaborations. To effectively move new interventions forward our contributions will particularly target the interfaces between innovation, validation and application.

 

The fields of activity comprise the provision of services and research in areas of:

  • collaboration in the collection of fundamental epidemiologic data
  • scientific contribution to the lead selection of new active molecules against neglected diseases
  • management of regulatory and investigator driven clinical trials
  • quality management of clinical trials through monitoring and audits
  • teaching and training on a variety of clinical trial and project management topics
  • assistance to product registration and strengthening of regulatory authorities
  • contribution to pharmacovigilance & drug safety in resource limited countries
  • input to procedures which allow access to new medicinal achievements in resource limited regions

 

The strategies of the MedRes entail the provision of high quality services through a contract research organisation specialised in: the conduct of clinical trials in resource limited areas (Pharmaceutical Medicine Unit) and the provision of services in other relevant areas of pharmaceutical medicine & medicines research; the proposal of specific training; and the conduct of research in selected competence areas including the development of large scale effectiveness studies.

Pharmaceutical Medicine Unit (PMU)

Since the year 2000, the Pharmaceutical Medicine Unit (PMU) has been the contract research organization of the Swiss TPH. The unit provides professional support to the conduct of clinical trials. The services range from complete management of clinical trials or development programs to selected contributions for site selection, design, organization, conduct, and/or monitoring of clinical trials in accordance with the relevant guidelines. The main focus is on poverty related and tropical diseases in low resource or industrialized countries. Monitoring of clinical trials can either be provided by our specialized staff based in Basel or through a network of over a dozen associated regional monitors.

Quality Management Services (QMS)

This staff section is instrumental in assuring the quality of the clinical trials and studies conducted in the department. It is dedicated to develop and organize specific training courses covering relevant topics of good clinical practice (GCP) and quality assurance.

Additionally, QMS provides respective services and offers auditing services to clients conducting clinical trials.

Research Cluster and Departmental Activities

The cluster comprises activities that go beyond the mandate of the service units because they are neither externally funded nor do they adhere to regulatory requirements, but rather support exploratory purposes. These projects are carried out by the staff of the service units and/or students and comprise research studies, investigator driven clinical trials and capacity building projects.
One example is the continued effort in the framework of the alliance for clinical research and clinical epidemiology in the Democratic Republic of Congo (see www.ARCEAU-RDC.org), which simultaneously marks the strategic inclusion of clinical research on non-communicable diseases in resource limited countries into our portfolio.