For study partners and sponsors
Research and care for your health
The CED-Studienzentrum Karlshorst is a specialized trial center for clinical studies on chronic inflammatory bowel diseases (IBD). We have many years of experience, established structures and a reliable study infrastructure.
Our center collaborates with pharmaceutical companies, CROs, university institutions and other research partners.
In collaboration with qualified research partners and subject to review by independent ethics committees.
Profile of the study center
Quality and compliance standards
- Implementation according to ICH-GCP
- Review by independent ethics committees
- Documentation in sponsor EDC systems as specified
- Standardized reporting of AEs/SAEs
- Regular internal quality controls
- Protocol deviation management according to SOP
All employees have valid GCP certificates and receive regular training.
Infrastructure and examination conditions
- Connection to a modernly equipped gastroenterological practice
- Separate study rooms for anamnesis, examinations and documentation
- Endoscopy with high-resolution technology (can be named more precisely if desired)
- Laboratory analysis (internal / external – please add if relevant)
- Storage areas with temperature monitoring for investigational medicinal products
- Secure archiving and documentation in accordance with GCP requirements
- Barrier-free access and good transport connections
Recruitment and patient population
Recruitment includes patients with moderate to severe chronic inflammatory bowel diseases. Both early and advanced stages of the disease are taken into account. Screening and preliminary assessment are carried out in a structured manner by the medical study team.
Recruitment takes place via the practice’s internal patient base, via regional referrers and via digital inquiries to the study center. High retention is supported by permanent contact persons, clear appointment structures and short distances within the center.
Investigator team & study coordination
Dr. med. Susanna Scharrer
Specialist in internal medicine and gastroenterology
Focus: Chronic inflammatory bowel diseases, interventional endoscopy and sonography
Dr. med. Thomas Brunk
Specialist in internal medicine and gastroenterology
Hematology and internal oncology
Focus: Gastrointestinal oncology
Richard Juma Otwo
Study Nurse
• Performing study-relevant examinations
• Documentation in the eCRF
• Coordination of all visit appointments
Nadine Petco
Study coordinator
• Appointment coordination
• Communication with CRAs/sponsors
• Administration of documents and investigator files (ISF/SMF)
• Logistics and documentation processes
Viola Heller
Study assistant
Electronic systems and documentation
- Support for all common EDC systems
- Use of eCRFs according to sponsor specifications
- Digital and physical archiving
- Temperature documentation of the investigational medicinal product
- Responsible for data management and queries
Current studies
Ulcerative colitis: MIRACLE study – Study partners
Efficacy of top-down therapy with mirikizumab compared to standard therapy with azathioprine in patients with newly diagnosed moderate to severe ulcerative colitis (MIRACLE) ClinicalTrials.gov ID: NCT07235904Sponsor: Universitätsklinikum Schleswig-Holstein...
Crohn’s Disease: SAR441566 Study – Study Partner
A study to investigate the efficacy and safety of SAR441566 in patients with Crohn's disease (SPECIFI-CD) ClinicalTrials.gov ID: NCT06637631Sponsor: Sanofi (Information provided by Sanofi (responsible party)) Study overview Official title: A multinational,...
Collaboration and communication with sponsors/CROs
Collaboration with sponsors and CROs is characterized by short response times, transparent communication and structured coordination in all study phases.
This includes the start-up, maintenance and close-out phase. Monitor visits are scheduled flexibly and reliably. The study center supports feasibility assessments and participates in investigator meetings if required.
