Registry Development Consultation, Development and Operation Support
About Us
Utilizing the know-how we have acquired as a joint research organization for the research projects of the Japan Agency for Medical Development (AMED), we support the establishment of a registry and smooth operation for clinical research, especially for academic societies and research groups (hereinafter referred to as academia).
In order to promote the secondary use of accumulated registry data for evidence generation research, post-marketing surveillance, and comparator groups, we act as a bridge between companies and academia, and help ensure the reliability of registry data when it is used.
EPS features
Future-Oriented Proposals
With extensive experience in the field, we propose an optimal research implementation structure and the launch of a progressive and sustainable system for the establishment and operation of the registry by academia, the registry owner.
Support for a Variety of Registry Operation Methods
There are a variety of research methods in the registry, such as conducting a test registry and then conducting clinical research based on the test results.
We provide the necessary support for the establishment and operation of a registry based on the needs of each research project. We also provide support for the utilization of existing research databases and medical records.
Full Support
In addition to acting as a bridge between academia (which owns the registry) and pharmaceutical companies, we provide consultation support for the registry with PMDA. We also provide support for ensuring the reliability of registry data and its use in regulatory applications.。
Services
Registry Development Consultation, Development and Operation Support
- Research implementation system and methods (data collection flow, etc.) consultation
- Consultation on the status of other research groups in response to unclear points and doubts
- Consultation regarding registry development considering collaboration with other companies
- Management of schedule and work process progress the start of the study
- Study protocols, informed consent forms, procedure manuals, survey forms, and EDC screens creation support
- EDC creation support in collaboration with EPS group companies
- Support for secretariat operations (progress management, account management, etc.)
- Data management operation support (data entry, query handling, etc.)
- Assist in approaching companies’ potential needs, coordinate with companies, and attend interviews