ENGLISH
DEUTSCH
NCT Trial Center
The NCT Trial Center is a clinical research platform, focusing on design, regulatory preparation, conduct and analysis of clinical trials in oncology, in close collaboration with the Coordinating Center for Clinical Trials (KKS Heidelberg) and the Department of Biometrics at Heidelberg University Hospital. With a staff of two biometricians, two data managers, one IT coordinator, two project managers, two physician/investigators and 6 study nurses it has layed the groundwork of an SOP-driven clinical research process at NCT, and integrates the trial structure between departments and other trial centers like the Clinical Trial Center KSC/SDGC of the HUMS Surgery Department.
A First In Oncology (FIO) program is using the dedicated Heidelberg University Hospital Phase I in- and outpatient unit with 12 beds (directed by Prof. Haefeli). From 2009 - 2010, NCT actively participated in 220 clinical trials and managed 90 IITs. IITs are encouraged by advising on preclinical strategy through dedicated advisory boards, and designing clinical development plans.
Every clinical trial initiative is brought to the clinical trials advisory council, which meets every 14 days. Rules guiding decisions involve feasibility, matching to the existing trial portfolio and overall NCT strategy, scientific excellence and innovation documented by the clinical research question. Additional services include Standard Operating Procedures ensuring appropriate medical practice, GCP and ICH compliance, budgeting, contracting, coordination of IRB and regulatory submissions, documentation, data management, statistical analysis, clinical services, electives for postgraduate trainees and courses in trial management in cooperation with the KKS Heidelberg.
Future goals include a close interaction with the NCT Cancer Registry and bioinformatics towards completing the comprehensive NCT cancer outcome database of all treated oncology patients. An extended collaboration between the NCT Trial Center, the Heidelberg University Hospital trial center (KKS) and the Institute for Biometrics will allow further growth of the number of trials supported by the NCT Trial Center, to focus trials scientifically, and to structurally integrate all oncology study sites on campus.
The Department of Medical Biometry with 60 staff has extensive expertise and experience in methodological-statistical support focused on statistical methods to optimize biometrical planning, conduct and analysis of clinical trials. Approved and implemented standard operating procedures are ensuring quality and efficiency at all stages of biometric support. Further research and service covers analysis of gene association and gene expression data. This collaboration allows outreach locally at non-University partner sites and platform work for partner institutions in the upcoming National Translational Oncology Consortium.
A First In Oncology (FIO) program is using the dedicated Heidelberg University Hospital Phase I in- and outpatient unit with 12 beds (directed by Prof. Haefeli). From 2009 - 2010, NCT actively participated in 220 clinical trials and managed 90 IITs. IITs are encouraged by advising on preclinical strategy through dedicated advisory boards, and designing clinical development plans.
Every clinical trial initiative is brought to the clinical trials advisory council, which meets every 14 days. Rules guiding decisions involve feasibility, matching to the existing trial portfolio and overall NCT strategy, scientific excellence and innovation documented by the clinical research question. Additional services include Standard Operating Procedures ensuring appropriate medical practice, GCP and ICH compliance, budgeting, contracting, coordination of IRB and regulatory submissions, documentation, data management, statistical analysis, clinical services, electives for postgraduate trainees and courses in trial management in cooperation with the KKS Heidelberg.
Future goals include a close interaction with the NCT Cancer Registry and bioinformatics towards completing the comprehensive NCT cancer outcome database of all treated oncology patients. An extended collaboration between the NCT Trial Center, the Heidelberg University Hospital trial center (KKS) and the Institute for Biometrics will allow further growth of the number of trials supported by the NCT Trial Center, to focus trials scientifically, and to structurally integrate all oncology study sites on campus.
The Department of Medical Biometry with 60 staff has extensive expertise and experience in methodological-statistical support focused on statistical methods to optimize biometrical planning, conduct and analysis of clinical trials. Approved and implemented standard operating procedures are ensuring quality and efficiency at all stages of biometric support. Further research and service covers analysis of gene association and gene expression data. This collaboration allows outreach locally at non-University partner sites and platform work for partner institutions in the upcoming National Translational Oncology Consortium.
Contact
NCT Trial Center
Im Neuenheimer Feld 350
69120 Heidelberg
For Non-Physicians:
Phone: +49 (0)6221 42-1630
Fax: +49 (0)6221 42-1617
E-Mail: studienzentrale@nct-heidelberg.de
For Physicians:
Phone: +49 (0)6221 56-6993
Fax: +49 (0)6221 56-6994
E-Mail: studienzentrale@nct-heidelberg.de
Im Neuenheimer Feld 350
69120 Heidelberg
For Non-Physicians:
Phone: +49 (0)6221 42-1630
Fax: +49 (0)6221 42-1617
E-Mail: studienzentrale@nct-heidelberg.de
For Physicians:
Phone: +49 (0)6221 56-6993
Fax: +49 (0)6221 56-6994
E-Mail: studienzentrale@nct-heidelberg.de
Further menue items
top of page