Clinical Trial Support
We provide our partners with a broad range of services for successful clinical trial operations. Leveraging our proprietary Bio/Databank, multiomic platform, and extensive network of physicians, our team of experts ensure efficient and effective solutions to drive progress in the rare disease space.
From overall study design and regulatory guidelines to patient access and general time and cost management, clinical trials can quickly become complex and resource intensive.
CENTOGENE is here to help streamline this process for our partners. We provide efficient, effective clinical trial support to help you optimize time and cost, while delivering the highest levels of operational and scientific excellence.
Based on the world’s largest rare disease-centric Bio/Databank of its kind and decades of combined experience, our clinical trial support team can help you:
- Further investigate new biomarkers
- Investigate disease prevalence
- Identify drug targets
- Monitor candidate therapies
- Validate new biomarkers as clinical endpoints
CENTOGENE services in clinical studies
CENTOGENE services in clinical studies span the full spectrum of customized solutions for orphan drug development including in vitro molecular screening, epidemiological studies, biomarker development as well as patient recruitment and identification.
over 30 pharmaceutical partners
CENTOGENE established collaboration agreements with over 30 pharmaceutical partners including Denali Therapeutics, Evotec AG, Orphazyme, Aldeyra Therapeutics and Chiesi Germany. Our joint projects involve thousands of patients affected with rare hereditary disorders. Pharma partners are provided with a wealth of information for their orphan drug trial programs fostering the development of new therapies.
rich collection of biological samples
CENTOGENE's clinical studies yield a rich collection of biological samples. Our highly innovative analytical platforms can analyze genetic, proteomic, transcriptomic and metabolomic data in addition to biochemical and clinical data. We have developed a powerful tool that helps patients by providing them with a quick diagnosis and expert guidance on treatment options.
We are currently carrying out an observational study to understand the prevalence of genetic mutations in patients with FTD. The observational EFRONT Study is being conducted with support from Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology.
This the study will continue to leverage CENTOGENE’s proprietary Bio/Databank to enroll and genetically test more than 3,000 FTD patients at participating centers in Belgium, Germany, Greece, Italy, Portugal, Spain, and Turkey.
Patients testing positive for the progranulin gene mutation (FTD-GRN) will have the option to then enroll in Alector’s Phase 3 INFRONT-3 clinical trial of AL001, an investigational therapeutic candidate designed to increase progranulin levels for the treatment of frontotemporal dementia and other neurodegenerative diseases.
Epidemiological Study in Frontotemporal Dementia (EFRONT)
EFRONT is a single visit, multi-centre, non-interventional study that investigates the prevalence of genetic etiologies in Frontotemporal dementia (FTD) by genotyping patients diagnosed/ suspected of FTD.
Hereditary Transthyretin-Related Amyloidosis and Monitoring of TTR Positive Subjects (TRAMmoniTTR)
The TRAMmoniTTR study, is a multicenter, epidemiological, longitudinal study to screen and monitor disease progression in patients who carry pathgenic variants of the TTR gene.
Rostock International Parkinson's Disease Study (ROPAD)
ROPAD is an international, multicenter, epidemiological, observational study to characterize the genetics of familial Parkinson’s disease. This study is closely linked to a follow-up (LIPAD) study with the University of Lübeck. Both studies aim to establish candidate biomarkers of the disease.
Peptide-Based Immunization for Colon- and Pancreas-Carcinoma (PiCoP-GLOBAL)
PiCoP-GLOBAL is an international multicenter epidemiological observational study with the goal to develop diagnostic tools for personalized, immune-based therapies in colon and pancreatic tumors. This study is closely connected to the national PiCoP study in Germany and a follow-up vaccination study.
Hereditary Angioedema disease (HAE Study)
HAE is an international, multicenter, epidemiological study to investigate the prevalence of Hereditary Angioedema (HAE) among participants with recurrent episodes of abdominal pain of no obvious etiology.
By leveraging our proprietary Bio/Databank, multiomic platform, and extensive network of physicians, we help de-risk orphan drug development for our partners by seamlessly identifying the right patients.