Our consulting services
Whether you are conducting a drug, medical device or other clinical trial, a cohort study or research with routine data:
- We provide advice, directly
and free-of-charge.
- We arrange and coordinate
all services.
Tips & support
| For concept creation | |
|---|---|
| Systematic literature search | More information |
| Free statistics consultation | More information |
| Refresh your statistical knowledge | To the references |
| Recruitment of study participants | More information |
| Integration of Patient % Publiv Involvement measures | More information |
| To obtain approval | |
|---|---|
| Determining the study/project category according to the Human Research Act (HFG) | Access the categoriser |
| Submission of the application to the ethics committee | Access guideline |
| Around your research data | |
|---|---|
| Create your own REDCap® database | More information |
| Importing data from secuTrial® into R | More information |
| Data transfer to the DKF | For instructions |
| For study preparation | |
|---|---|
| Training for new Study Nurses at the USB | Arrange appointment |
| Templates for forms, checklists, logs, etc. | Request access |
| SOP templates | Request access |
| During study conduct | |
|---|---|
| Adverse event reporting | Access info sheets |
| Study inclusion of children, adolescents or persons in emergency situations | Access info sheets |
| Consent of persons providing their data and samples | Access info sheet |
Tools & Resources
Tools and information resources for academic clinical research compiled by the national platforms of the Swiss Clinical Trial Organisation (SCTO)
Free-of-charge for DKF research groups
| Data Analysis/Statistics |
|---|
| Statistics consultation |
| Sample size calculation and feasibility check |
| Data Management |
|---|
| Validated RedCap® instance for own development of a study database |
| Data Science |
|---|
| Consultation hour for technical questions on data preparation and visualisation, R and RShiny programming |
| Monitoring |
|---|
| Monitoring plans for category A studies |
| Outpatient Study Centre |
|---|
| Use of faciliies and infrastructure |
| Patient & Public Involvement |
|---|
Support in writing PPI plans and implementing PPI measures |
Support in implementing PPI measures |
| Project Management |
|---|
| Support and Management of Data Safety Monitoring Boards |
| Quality Affairs |
|---|
| Consulting on quality management systems (QMS) |
| Use of the QMS tool Orca |
| Support during audits & inspections, incl. preparation of CAPA plan |
| Regulatory Affairs |
|---|
| Regulatory review of study documents |
| Initial submission to ethics committee and authorities |
| Submission of amendments (after prior evaluation) |
| Support and Management of Data Transfer & Use Agreements |
| Study registration (applies to all studies at USB) |