Clinical Trials Unit — Medical Research Centre

The key elements of a clinical research project are discussed and defined during the study advisory service. Together with the project leader, we define the scientific question, the study design, the regulatory requirements and the study procedure.

An initial consultation is free of charge for researchers at HOCH Health Ostschweiz.

Project management accompanies all phases of the clinical research project. This involves preparing the research budget, negotiating contracts with partners, drafting study documents and preparing and submitting applications to authorities such as the Eastern Switzerland Ethics Committee and Swissmedic. Throughout the project, we coordinate and communicate with the participating centres, train the study teams, and monitor safety requirements. Finally, we coordinate the archiving process and prepare the final study report.

Monitoring is an essential part of quality control in clinical trials. This involves verifying that study data are recorded accurately, completely and traceably. Additionally, it ensures that the trial has been conducted in accordance with the protocol, Good Clinical Practice (GCP) guidelines, and applicable legal requirements.

An audit is conducted to determine whether the study was conducted in accordance with the approved protocol. The focus lies in determining whether the processes and documentation align with the established requirements and legal guidelines.

Particular attention is given to patient safety and rights, as well as the quality of the study data.

Study coordination and assistance support the planning, organisation and conduct of clinical studies.

Services include:

• assistance with the planning and budgeting of clinical trials

• Organisation and preparation of patient inclusion

• coordination of appointments for study visit

• Administration of study medication

• Collection and documentation of study data

• Nursing assistance within the scope of clinical trials

• Collection, preparation

The CTU has the suitable infrastructure to store samples at temperatures as low as -150°C under controlled conditions. A data recorder continuously monitors the temperature, and the logs are made available.

Sterile sample processing is also possible.

The CTU offers biostatistical support in the design of new studies and the evaluation of collected data. Researchers at HOCH Health Ostschweiz receive a free initial consultation for new projects.

Ideally, you should contact the biostatistics team during the conception phase.

Our services include:

• Defining hypotheses and endpoints

• Calculating sample sizes

• Interim analyses for ongoing studies

• Preparation and presentation of data

• Significance tests

• Description of statistical methods and results for publication

The data management team generates legally compliant databases for recording study-specific data. For this purpose, the SecuTrial and REDCap programmes are used. Both are mobile-compatible and well-suited for creating study registries. We also offer support in developing a data management plan.

The CTU regularly organises GCP courses and GCP refresher courses.