Located at the University of Cologne, the CTC Cologne as a specialized institution accompanies and accelerates latest research approaches with specific scientific services and infrastructure.
The CTC Cologne supports Europe-wide physicians and scientists at universities, clinics and research clusters (Investigator Initiated Trials, IITs) as well as pharmaceutical companies and medical device manu-facturers in almost all indications. The CTC Cologne operates according to the standards of GCP as well as relevant national and international directives, guidelines and standards.
The CTC Cologne acts as a link between the University Hospital and the University of Cologne: due to the close cooperation with natural sciences and the coordination of scientific networking, promising findings from basic research can be quickly transferred to clinical practice. An ISO-certified, detail oriented quality management system supports the paramount duty of CTC Cologne: The well-being and safety of patients.
Additionally, the Academy of CTC Cologne qualifies study staff through specific clinical research related training courses.
- Trial concept and design, trial feasibility
- Regulatory classification
- Cost calculation
- Financing sources and funding options
- Sponsor responsibilities according to AMG/MPG/GCP
- GCP-compliant quality management including RBQM
- Trial conception and sample size calculation
- Site feasibility
- Contact to clinics, institutes and practitioners networks
- Development of trial protocol, patient informed consent form, manuals, etc.
- eCRF development
- Setup and validation of the trial database
- Regulatory management (e. g. trial registration, trial application to authorities and ethics committees))
- Drafting and tracking of contracts (e.g. trial sites, service providers)
- Project management
- Maintenance of databases, ongoing data management
- Safety management (using a validated safety database)
- Medical monitoring
- On-site and remote monitoring