Clinical Trial Unit

Study guidance is a service offered by Hirslanden Clinical Trial Unit; it is available to all departments and to those interested in research within the Hirslanden Group. 

Study guidance includes the following aspects:

• Feasibility studies
• Study design
• Study protocol
• Biostatistical concept, data collection and evaluation

Hirslanden CTU assists investigators with submitting study files to ethics committees, Swissmedic and other authorities. Please contact us for further information on applying for ethics approvals.

Our offer includes: 

• Clarifying regulatory requirements
• Classifying clinical project risks
• Reviewing study documents as regards content and regulatory compliance
• Preparing and submitting study files to ethics committees, Swissmedic and authorities
• Registering studies
• Communicating with authorities and carrying out process control for study documents

The Clinical Trial Unit team will assist you in all your clinical trial phases. If you require project-oriented preparation and an appointment with Hirslanden CTU, please send any available study documents to Hirslanden CTU so we can assess the project and workload.

Our offer includes:

• Contract and insurance management
• Implementing trial master files, including maintenance
• Preparing, submitting and maintaining study documents with authorities
• Planning and coordinating study-specific work, incl. training study staff
• Notifying the sponsor and the ethics committee
• Writing annual safety reports for the ethics committee
• Preparing, distributing and withdrawing test products
• Implementing data management plans
• Support for data capture and validation

The Human Research Act (HFG), the Ordinance on Clinical Trials (KlinV, KlinV-Mep), EN ISO Standard 14155 and the ICH-GCP guidelines prescribe the need for monitoring and quality control. To guarantee valid study results, Hirslanden CTU implements quality assurance and quality control measures. The accuracy and completeness of study documents are checked during monitoring visits. 

Our offer includes:

• Developing a risk-adapted concept for monitoring
• Training study staff at the study sites
• Ensuring compliance with GCP processes 
• Assisting with audits by authorities and sponsors
• Assisting with query management and safety reporting
• Conducting initiation, interim and final visits

Monitors are contacts before, during and after the study. 

Hirslanden CTU study coordinators and study nurses will assist you with all aspects of your daily clinical study activities. The team handles various tasks such as the timely appointment of study patients, implementing study visits as well as processing and dispatching study-specific laboratory samples.

Our offer includes:

• Planning the logistical process at the study site
• Collecting and documenting study data
• Conducting study visits
• Processing and sending clinical samples
• Providing support for monitoring visits and query management
• Organising the compensation of study patients
• Documentation
• Controlling the database
• Implementing data management reports and rules for monitoring project progress
• Offering continuous personal support by mail and by telephone
• Archiving study documents

We will assist you with data management throughout the entire study phase. Our data managers will help you to enter study-result-related data and create electronic case report forms in accordance with the applicable Swiss guidelines. Hirslanden CTU uses the browser-based software solution REDCap to record patient data. To guarantee valid study results, we implement quality control and quality assurance measures.