Conducting Clinical Trials

IGES Pharma conducts clinical studies for the pharmaceutical industry. This is done by CSG, a member of the IGES Group. CSG supports clients from the pharmaceutical sector, biotechnology and the medical device industry in the planning, execution and evaluation of clinical scientific studies. Thanks to the many years of experience and the know-how of our staff, as well as the use of state-of-the-art technologies, CSG ensures that projects are carried out in a cost- and time-efficient manner.

The focus is on the following types of clinical trials:

Clinical trials of pharmaceuticals

The conduct of clinical trials to assess the efficacy and safety of pharmaceuticals before, during and after approval is subject to strict and constantly changing legal, regulatory and ethical requirements.

As a competent partner, CSG supports its clients in successfully conducting the following studies:

• Phase II and III studies
• Phase IV studies
• Non-commercial trials (IITs - Investigator Initiated Trial)

Non-interventional studies of pharmaceuticals

Evidence-based proof of the benefits of pharmaceuticals is of great importance for the use and reimbursement of such products. In addition to clinical trials, well-designed studies of approved pharmaceuticals under real-life conditions can provide important insights.

CSG offers tailor-made concepts for the implementation of the following studies:

• Observational studies (PMS - Post-Marketing Surveillance) - Prospective cohort studies, Retrospective case-control studies, Cross-sectional studies.
• Safety evaluations (PASS - Post-Authorization Safety Study)

Clinical studies of medical devices

Due to the increasing legal requirements in the context of clinical evaluation for the certification and proof of benefit of a medical device, the performance of clinical studies is becoming more and more important.
CSG successfully supports clients in conducting the following studies:

• Interventional studies (§§19-23a MPG)
• Non-interventional studies (§23b MPG)
• Non-commercial studies (IITs - Investigator Initiated Trial)

Biomarker studies

The development of new biomarkers for the diagnosis of diseases and the prognostic assessment of possible individual treatment strategies has become increasingly important over the last years. Scientific studies for the identification and validation of biomarkers are subject to specific regulatory and data protection requirements. In compliance with good clinical practice, CSG offers competent concepts for the conduct of such studies:

• Regulatory requirements for sample collection studies.
• Data collection in sample collection studies
• Logistics for sample collection studies
• Data protection / data trusteeship for biobanks

Digital health product studies

CSG is one of the pioneers in the field of clinical trials for the proof of benefit of digital health products. The focus is on studies conducted for the purpose of proving the so-called "positive health care effect" (in German “Positiver Versorgungseffekt”). On this basis, a digital health product can be listed as a DiGA. CSG offers the following services in this context:

• Strategic advice on the proof of benefit, including choice of the relevant procedure (preliminary or final listing).
• Determination of the comparison group to prove the positive health care effect
• Evaluation of studies not conducted in Germany
• Dialogue with the Federal Institute for Drugs and Medical Devices (BfArM)
• Study planning and execution for DiGAs
• Study planning and execution for Digital Health Products reimbursed outside of the DVG (Digitales-Versorgungs-Gesetz)

For more information about CSG, please contact us:

CSG - Clinische Studien Gesellschaft
Friedrichstrasse 180
10117 Berlin
Germany
P: +49-30-230 809-0
csg@csg-germany.com
www.csg-germany.com