NCT Research

Contact

 

NCT Studienzentrale
Marsilius-Arkaden / Turm West
Im Neuenheimer Feld 130/3
69120 Heidelberg
studienzentrale@nct-heidelberg.de
Phone: +49 6221 566294
Patients please refer directly to Patient site».

NCT Trial Center

The NCT Trial Center stands for competent consulting, planning and implementation of clinical-oncological studies. Central pillars of its range of services are:

  • project management,
  • biostatistics,
  • data management,
  • medical informatics,
  • study coordination and assistance,
    as well as
  • continuing education.

The Trial Center supports NCT research in finding evidence-based solutions in the prevention, diagnostics and therapy of cancer diseases.

The NCT Trial Center supports clinical-oncological and epidemiological studies conducted by the German Cancer Research Center Heidelberg and Heidelberg University Hospital with a wide range of services. Competent staff provide services in the fields of project management and study coordination, biostatistics, data management, information technology, study assistance and continuing education. The goal is to plan, conduct, analyze, report and evaluate clinical studies. Quality-controlled processes and templates that comply with Good Clinical Practice (GCP) ensure that sponsor and study tasks are carried out according to international standards within an efficient infrastructure.

The NCT Trial Center operates in close cooperation with other academic research institutions on the campus, especially the Koordinierungszentrum für klinische Studien (KKS, Coordination Center for Clinical Trials) and the Medizinische Biometrie und Informatik (IMBI, Medical Biometry and Informatics) of Heidelberg University Hospital. Further cooperative agreements exist with public research institution partners and industry locally, nationwide and abroad.

The NCT Trial Center is also a point of contact for industry organizations in search of clinical partners. In particular, it assumes the coordination of oncological cross-sectional studies involving various indications and with the participation of multiple clinics of Heidelberg University Hospital.

NCT Trial Center

Services

The key task of the NCT Trial Center is the development and conducting of innovative clinical studies. The focus is on initiating academically motivated oncological studies with particular clinical significance, novel scientific issues, interdisciplinary character and new innovative drug substances and treatments.

NCT Core Services

Staff members of the NCT Trial Center

Clinical studies are supported by experienced and continuously trained personnel throughout all phases, beginning with the study concept, during application and execution all the way to publication. In addition, central IT projects such as cross-linking and migration of large quantities of data, pseudonymization services and online questionnaire tools are initiated and supported. The NCT Trial Center also assists and maintains cooperation with academic trial-supporting institutions locally, nationally and internationally.

Project Management provides early consulting and assistance during the conception of clinical studies. It ensures that sponsor tasks and study topics are planned and optimized according time, resources and budget, and comply with the relevant regulatory standards. The central tasks of Project Management include coordinating all process steps with the involved parties.

In the early planning phase Project Management 

  • provides regulatory advice and budgetary planning,
  • supports the feasibility analysis of study ideas,
  • assists with funding applications, and
  • the drafting and negotiation of contracts.

Comprehensive quality-assured templates are available for preparing the necessary study documents for ethics committee and regulatory authorities. The Trial Center actively assists in the

  • preparation of study documents and
  • application and notification procedures for ethics committees and regulatory authorities.

After initiating the study, the Trial Center monitors progress, budget adherence and reporting activities. It coordinates study logistics and serves as the central point of contact for trial centers and clinical monitors.

After the study is completed, close-out of all centers and preparation of the final reports within the deadline together with biostatistics and data management is taken care of. In the same way, the Trial Center also supports your study during audits and inspections.

Biostatistics provides early help in the planning and conception of clinical trials. It is responsible for statistical guidance and biometric appraisal and the interpretation of clinical research projects.
Its functions include:

  • conception of clinical studies in close cooperation with internal and external partners
  • guidance in the selection of study design, the target population and objectives criteria
  • selection of statistical methodology and calculation of the required sample size
  • conducting statistical analyses, reporting, and interpretation of the results 

During the planning of a study, biostatistics is responsible for development of the statistical parts of the trial protocol, the randomization plan and the statistical analysis plan. During conduct of the study, it carries out interim statistical analyses and reports. At the end of the study it is responsible for statistical analysis, the preparation of study reports and the statistical interpretation of results. It also participates in preparing the publication and in presenting the study results at scientific conferences.

Data Management provides for the integrity and validity of the acquired and analyzed data through organizational, methodological, conceptual and technical measures. It is involved in the development of the trial protocol and prepares paper-based or electronic Case Report Forms. At the beginning of the study preparation and release of the trial database and the designing of data input masks is of particular importance.
In the further course of the study, the main functions include:

  • monitoring the entire data flow,
  • double data entry process,
  • creation of trial-specific programs for quality control of the data.

Data Management develops computer programs for processing and evaluating study data for reports, presentations and study conferences. As a quality assurance measure, all relevant process steps and the validation of developed computer programs are documented.

The use of IT systems in conducting clinical studies is of great importance. Therefore the NCT Trial Center provides professional support and assistance in information technology for all aspects of clinical studies.
Services include:

  • online tool for electronic questionnaires
  • data management systems and audited databases for data management
  • trial information system for the NCT
  • pseudonymization services for electronically transmitting clinical data for research purposes in compliance with data protection regulations

The installation, validation and documentation of IT systems and software using standard operating procedures assures the high quality of information technology at the Trial Center. The integration of IT equipment of pharmaceutical companies and external partners in the IT environment is coordinated. Competent consultation for GCP in IT issues rounds off the range of services provided.

Trial Assistants assist the investigators in the professional and quality-assured conducting of clinical studies. The NCT Trial Center provides Trial Assistants especially for NCT cross-sectional studies.

Trial Assistants supervise the study participants and assist the investigator in study initiation, execution, patient visits and monitoring visits. Their responsibilities include

  • assistance in patient recruitment,
  • supervision of study investigations,
  • documentation of study data,
  • maintenance of the investigator site file, and
  • investigational medical product and sample logistics.

Quality assurance is an essential element of good clinical practice and therefore a central element of the NCT Trial Center. It comprises a broad spectrum of coordinated processes that are summarized in standard operating procedures (SOPs). They provide a broad spectrum of working documents, outlines and checklists.

The NCT Trial Center assists the local trial sites in establishing site specific SOPs for the conducting of clinical studies. To this end staff experienced in QM provide advice and support during the preparation process. Furthermore, a QM coach can help in developing a QM system for a trial center.

 

 

Study-oriented training and ongoing continuing education qualifies our staff and ensures the GCP-compliant conducting of studies. For this purpose, the NCT Trial Center provides training for investigators and clinical staff on many topics concerning clinical studies. These include investigator training with additional oncological content in cooperation with the KKS Heidelberg, GCP training, data protection courses and also continuing training sessions focused on individual requirements or the current situation (e.g. changes in the law, tissue studies, radiation protection regulations, data protection in clinical trials, and many more).

We provide the opportunity for study personnel to conduct their clinical studies making use of the Trial Center, in close cooperation with the Trial Center’s functional sections and making use of the available quality assured processes. For new staff, a comprehensive function-specific introductionary training concept facilitates rapid and comprehensive qualification.

The NCT Trial Center also offers internships for trainees, retrainees and students in all areas of operation.

Study spectrum

The NCT Trial Center provides information on the clinical studies of the NCT to physicians.