Our service | PFZ

Every research project starts with planning.

In addition to determining the optimal study design to answer the research question, planning also includes aspects of practical implementation. Particularly in the case of studies with newborns, infants, children and adolescents, special requirements must be observed.

We support you in the design of your research project and work with you to develop a suitable, practice-orientated study concept that is tailored to your research question.

Our offer:

• Advice on study design in consideration of:
• • Effort and feasibility
  • Logistical feasibility

If there is clarity about the desired study design, the category of the Swiss Human Research Act (HRA) can be determined for the project. This categorisation determines the approval and reporting obligations, as well as the selection of suitable templates for the creation of your study protocol and patient information.

We help you to classify your research project and support you in the further processes and compliance with national and international regulations and requirements.

Our offer:

• Advice on the categorisation of the research project
• Regulatory review of the study protocol and patient information
• Support with submission to ethics committees and Swissmedic
• Assistance with drafting and submitting amendments (subsequent changes to the study protocol)
• Review of safety reports (annual safety reports)
• Data Transfer User Agreements (DTUA)

It is important to define the conditions in order to be able to optimally accompany a study. This is usually done with an agreement. If the project partner is a pharmaceutical company, the content of the company's contract is first checked within the PFZ and then by the legal department of the USB.

The complete financial and administrative process of a study with a pharmaceutical company or an academic sponsor can be handled by the PFZ.

Our offer:

Professional support from a specially trained team is very important when conducting clinical trials with children and adolescents. The high legal requirements for conducting trials are guaranteed by a well-trained team of study nurses and study coordinators at our centre.

Our offer:

• Support in creating specific study documents (Case Report Form, Trial Master File, Investigator Site File)
• Preparation of initiation visits in collaboration with the PI and sponsor
• General support and counselling of PIs in the planning and implementation of study visits
• Screening, education and inclusion of study participants
• Organisation and implementation of study visits
• Supervision and monitoring of study participants in specific study rooms
• Protocol-compliant acceptance, processing, storage and dispatch of study-specific samples
• Protocol-compliant dispensing and storage of study medication
• Preparation and follow-up of monitor visits
• Carrying out the study documentation with the specified databases
• Support for close-out visits
• Archiving of study documents
• Proper destruction of remaining stocks of study medication
• Hub and network for all relevant services at UKBB (laboratory, ICT, outpatient clinic, CTU-USB, USB laboratory, hospital pharmacy)
• Service agreement with internal / external clients
• Contact for sponsor and monitor

Data collection and recording (data management) and subsequent data analysis (statistics) should be considered as early as the project planning stage. A data basis that meets the high quality standards is a prerequisite for consistent and reproducible results. Our qualified biometricians will be happy to support you in this.

Our offer:

High-quality data management is becoming increasingly important due to legal requirements and growing awareness of quality control and quality assurance in clinical trials. For the digital recording of your data, we offer REDCap a software solution.

Our offer:

• Setting up the web-based application REDCap for creating and managing online surveys and questionnaires (CRFs) with the following functions:
  • Comprehensive role and rights management
  • Support of multi-centre studies via data access groups
  • Randomisation
  • Audit Trail
  • Query management
  • Data import/export in different formats
  • Creation of study reports
• Support for researchers in setting up their own REDCap databases.

In many research projects, the storage of residual materials from research samples under high quality standards is of great importance.

The PFZ biobank at the UKBB enables researchers to carry out biobanking as part of their studies according to individual planning in temperature-controlled freezers Our biobank has been awarded the VITA label of the Swiss Biobanking Platform (SBP) and fulfils all regulatory requirements. Quality assurance measures ensure optimal storage of your samples.

Our offer

• Advice on project-related biobanking
• Implementation of project-related biobanking.