The HTR provides a range of support services to improve the quality of clinical trials.
The HTR is a one-stop destination for clinical trial services. The Department of Clinical Trial Management assists as a data center, with statistical analysis, and for CPC related services in the clinical trials of all seeds research projects and also engages in consultation related to clinical trials.
Support for Development and Creation of Clinical Study Plans
The HTR supports clinical trials at the initiative of medical doctors and researchers. The HTR supports the planning necessary to proceed to clinical trials and so enables a realization of practical use of Seeds Research.
The HTR provides support in the design of clinical trials, identifies the primary endpoint, estimates the sample size required in a trial, the methods of statistical analysis,and reviews the biostatistical issues in clinical trials.
The HTR also assists in the interpretation of results and handling of peer-review comments related to statistics.
Help with Preparing Documents
The HTR arranges the registration of cases and supervision of the progress when conducting clinical trials.
The HTR is in charge of all work related to data management such as the design and development of clinical databases, input of data and QA/QC.
Supervision of Safety Information
To ensure the safety of subjects participating in clinical trials, the HTR collects and analyzes information on adverse side effects in subjects and critical information on safety of developed products. The HTR takes part in the supervision of safety information in accordance with relevant regulations, GCP is one such example, by accommodating details of the clinical trial plans and providing information to the subjects.
The analysis of the research data generated by Seeds Research projects is conducted by the HTR. In the statistical analysis, the HTR ensures the validity of scientific evidence being substantiated, including the selection of relevant parameters fitting the research design. Advice on the implementation of the advanced analyses required for publication is also provided.