CSG
CSG Clinische Studien Gesellschaft mbH is a full-service Contract Research Organization (CRO) specializing in clinical research, including clinical trials, non-interventional studies, biomarker studies, and pharmacovigilance. With over 20 years of experience, they support pharmaceutical, biotech, and medical technology companies in conducting high-quality, efficient clinical studies. They are part of the IGES Group, which provides a broad spectrum of health and infrastructure research and consulting services. CSG is committed to delivering tailored solutions with high standards of quality and expertise, leveraging modern technologies and a comprehensive understanding of the market and regulatory requirements.
Industries
Nr. of Employees
small (1-50)
CSG
Patents
Organosilicon antimicrobial solution, organosilicon antimicrobial agent, antimicrobial glass, preparation method therefor and use thereof
US-11219217-B2
View Details
Organosilicon antimicrobial solution, organosilicon antimicrobial agent, antimicrobial glass, preparation method therefor and use thereof
US-11219217-B2
View DetailsServices
Protocol design, endpoint definition, CRF development and preparation of all required study documentation for interventional and non-interventional studies.
Central project management coordinating study activities, timelines and budgets and serving as primary interface for sponsors.
Assessment of regulatory requirements and preparation/submission of applications to authorities and ethics committees, plus study registrations and notifications.
EDC implementation, CRF development, database creation, data import/export, ePRO/eDiary setup and custom reporting for clinical studies.
Feasibility assessments, site selection, on-site and remote monitoring, source data verification and risk-based monitoring approaches.
Statistical planning and analysis including sample size considerations, statistical analysis plan development and delivery of analysis results.
Protocol design, endpoint definition, CRF development and preparation of all required study documentation for interventional and non-interventional studies.
Central project management coordinating study activities, timelines and budgets and serving as primary interface for sponsors.
Assessment of regulatory requirements and preparation/submission of applications to authorities and ethics committees, plus study registrations and notifications.
EDC implementation, CRF development, database creation, data import/export, ePRO/eDiary setup and custom reporting for clinical studies.
Feasibility assessments, site selection, on-site and remote monitoring, source data verification and risk-based monitoring approaches.
Statistical planning and analysis including sample size considerations, statistical analysis plan development and delivery of analysis results.
Expertise Areas
- Clinical trial management
- Non-interventional and real-world evidence studies
- Pharmacovigilance and safety management
- Biomarker study design and logistics
Key Technologies
- Electronic Data Capture (EDC) systems
- ePRO / eDiary solutions
- Real-world data / routine data analysis
- Statistical analysis and SAP development
News & Updates
CSG successfully supported the introduction of Germany's first gastroenterological digital health application (DiGA), demonstrating that high-quality evidence generation for digital health apps is feasible with appropriate methods and expertise.
CSG successfully supported the introduction of Germany's first gastroenterological digital health application (DiGA), demonstrating that high-quality evidence generation for digital health apps is feasible with appropriate methods and expertise.