Our clients benefit from the flexibility of an expert CRO.

As part of the IGES Group, CSG ensures synergies with complementary fields of research. This results in an excellent knowledge of the market, its players and developments. In connection with the broad range of methods, more options arise for actions for tailor-made project results.

CSG has expanded its pharmacovigilance division since 2023 and offers its clients a wide range of PV services with a team of PV experts with extensive industry experience.

CSG provides a range of pharmacovigilance and risk management services to its clients, which includes Pharmaceutical, Medical Device, and Vaccine companies and manufacturers.

These services encompass:

• On an executive level:
• Interim Pharmacovigilance management.
• Strategic pharmacovigilance consulting.
• Creation and maintenance of Risk Management Plans (RMPs).

• On structural level::
• Qualified Person for Pharmacovigilance (QPPV) and a backup, available 24/7
• Signal management

• On a study/cases level:
• Serious Adverse Event (SAE) management
• Reporting of Suspected Unexpected Serious Adverse Reactions (SUSAR).
• Medical Monitoring
• Participation/Leading Drug Safety Monitoring Boards (DSMB)
• Generating narratives for Clinical Study Reports

• On a product level:
• Compilation of periodic pharmacovigilance reports Periodic Safety Update Reports, Periodic Benefit Risk Evaluation Reports, Development Safety Update Reports.
• Participation/Leading Drug Safety Monitoring Boards (DSMB).

CSG provides PV services on high quality level. CSG supports the design, implementation, maintenance, and optimisation of pharmacovigilance structures in its clients' organisations and helps manufacturers of medical devices and medicinal products including vaccines to ensure high standards in pharmacovigilance and risk management activities, compliance with all legal requirements, and achieving optimum product safety.

For more than 15 years, CSG as an independent contract research organization has been supporting clients from the pharmaceutical sector, the fields of biotechnology and medical device manufactoring in planning, implementing and analyzing clinical-scientific studies. Due to our long-term experience and our employees’ know-how as well as the usage of state-of-the-art technologies, CSG ensures the cost- and time-effective implementation of projects. The focus lies on the following study types:

Clinical trials for pharmaceuticals

The implementation of clinical trials to assess the effectiveness and safety of pharmaceuticals before, during and after authorization is subject to strict and constantly changing statutory, regulatory and ethical requirements.

As a competent partner, CSG supports clients in the successful implementation of the following studies:

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

Non-interventional studies of pharmaceuticals

An evidence-based proof of benefits of pharmaceuticals is of major importance for the use and reimbursement of such products. In addition to clinical testing, well-planned trials of authorized pharmaceuticals can provide important insights under routine conditions.

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 trials for medical devices

Due to the growing statutory requirements in the framework of the clinical assessment for the authorization and the proof of benefits of a medical device, the implementation of clinical trials is gaining in importance.
CSG assists clients successfully when implementing the following studies:

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

Biomarker studies

The development of new biomarkers for the diagnosis of diseases and the prognostic estimation for potential individual treatment strategies increasingly gained importance in the course of the last years. Scientific studies to identify and validate biomarkers are governed by specific regulatory and data protection requirements. Subject to the adherence to the good clinical practice, CSG offers competent concepts for the implementation of such studies:

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

• We stay on top of things - thanks to profound market expertise
• We have a great network - in close cooperation with IGES experts
• We are flexible - in synergistically working project teams
• We work accurately - with experience and diversity of methods

Our services cover the entire range applied in the planning, implementation and analysis of interventional and non-interventional clinical studies with pharmaceuticals or medical devices. Thereby, we always follow our clients’ needs in order to find optimal, practical solutions for the respective issue, which we implement cost- and time-effectively. To meet the highest quality standards, our experienced and highly qualified employees work according to SOPs (standard operating procedure) which correspond to the applicable legal requirements and standards.

CSG as full-service CRO supplements the services offered by the IGES Group synergistically when primary data is required as proof of benefi ts or safety.

With CSG, the clinical research has been an own independent work area within the IGES Group for 20 years:

Leadership

Dr. Marc Kurepkat

CEO

Marc Kurepkat, doctor of medicine, is a specialist physician for general medicine, working for more than 20 years in executive positions within the German health care system. Since 2001, he has been closely affiliated to the IGES Group, at first as the COO of the CSG then as a consultant. Main focus of his work are Real World Data, chronic diseases und digitalization of research and care.
Clinical training stations in internal medicine and geriatrics, work as an emergency medicine physician, doctorate in infectious diseases. After his residency, he was one of the pioneers of imparting digital knowledge of medical information for consumers and medical professionals (Bertelsmann Mediengruppe). In the 2010s, he founded a medical StartUp (medical centers, psychotherapy, nursing, physiotherapy). Marc Kurepkat has been significantly involved in the development of several chronic care programs and digital health applications. Furthermore, he is active as a physician in ambulatory care.

Our employees pursue a consistent advisory approach.
From the project idea through to the report we keep the study’s goal in mind.

A holistic perspective and high accuracy are a matter of course in
standardized study processes just as in challenging constellations.

This makes CSG a CRO that doesn’t lose sight of the big picture.

Dr. Marc Kurepkat

Your specialist issues will be in good hands with me.
Want to know more?

Get in touch

T +49 30 230 809 0
csg@csg-germany.com