We support researchers from idea to completion of a clinical research project. Therefore, CTU Bern provides different types of consulting services for clinical researchers. It is important that researchers contact us early enough especially in the planning phase of their project – it is never too early for the first contact. If support is needed on different topics, we can provide the respective expertise. However, this requires that any enquiry should be as specific as possible so that we can ensure that all expertise is actually available.
Regulatory Affairs and General Consulting
Legal and regulatory requirements for clinical research projects are extensive and complex. This can be challenging when preparing and conducting research projects. We advise on questions regarding
- the study protocol and other study documents e.g. participant information and consent form,
- regulatory requirements especially for clinical trials with pharmaceutical products or medical devices such as categorization, applicable standards and processes etc.
- submission to competent authority such as ethics committees and Swissmedic
- re-/further use of data and related data protection aspects
If you have any questions, please contact us by mail firstname.lastname@example.org
Standards and requirements for research data management have developed extensively over the last years. The Data Management division of CTU Bern provides consulting on various aspects especially with regard to study database design and set-up.
If you have any questions, please contact us by mail email@example.com
Statistics and Study Design
Experienced statisticians provide consulting for clinical researchers, who seek support in the planning phase of a clinical study project or have specific questions regarding statistical analysis.
We offer consulting meetings on any methodological or statistical topic (e.g. study design, approach to sample size calculation, approach to statistical analysis, data sharing), or a possible collaboration. The CTU statistician will discuss the project and possible approaches with you, and will give specific advice, however, we cannot provide any formal calculation, analysis, or statistical writing within the scope of this service.
Please subscribe to the service using one of the following options and indicate the purpose of the consulting (study design, statistical analysis, or other request):
Support for Study Protocol Development
We offer statistical support for protocol development if you plan a research project and would like to collaborate with CTU Bern during the conduct and analysis of the study. An experienced statistician will discuss the project with you and give advice on the study design, sample size calculation, and statistical methods. Within the scope of this service, the statistician can perform a standard sample size calculation and help with writing the statistical section of the protocol. Support is free of charge, as long as methods are not too elaborate and complex. Please apply for this service at least one month before you plan to submit the study protocol to the ethics committee, and provide a study proposal or outline.
Support for Grant Application
We offer statistical support for grant applications if you plan a research project and would like to collaborate with CTU Bern during the conduct and analysis of the study. An experienced statistician will discuss the project with you and give advice on the study design, sample size calculation, and statistical methods. Within the scope of this service, we can support you with sample size calculation, writing sections of the grant proposal, and budgeting. Support is free of charge.
Please apply for this service considering the following timelines, and provide a study proposal or outline.
- SNSF IICT programme: 1 May (one month before submission deadline for letter of intent)
- Other SNSF or EU grants: 2 months before grant submission deadline
- Other grants: 1 month before grant submission deadline