Successful development of a next-generation Electronic Data Capture (EDC) system to enable automatic transfer of clinical trial data from electronic medical records　~Effort with Kobe City Eye Hospital, Kobe, Japan~

As a part of our work in digital innovation of healthcare we are promoting, we, Remedy & Company Corporation (Chiyoda-ku, Tokyo, Founder and CEO Masakuni Ukita and hereinafter referred to as “Remedy & Company”), have successfully developed an electronic data capture (EDC) system which can automatically extract and transfer data required for clinical trials from the electronic medical records of Kobe City Eye Hospital, a hospital under Kobe City Hospital Organization, (hereinafter referred to as Kobe City Eye Hospital) to the EDC system.

Under normal circumstances, since important personal information such as patient’s diagnostic and treatment data is being handled in electronic medical records, they are strictly managed within the network of a healthcare institution. Therefore, great difficulties are presented when automatically transferring electronic medical record data managed within from a healthcare institution to an EDC system located outside due to security reasons. In addition to the workload when transferring first record entered in the electronic medical record to the system, the measures taken to prevent human errors such as input errors, as well as the need for inspection using Source Data Verification (SDV) and remote monitoring, a huge amount of labor is required in the process of achieving so, resulting in great challenges.

With tackling these challenges as our main goal, we have developed our own method that enables automatic extraction and transfer* of required data for clinical trial from electronic medical records and use it to build a novel EDC system that can automatically transfer data from electronic medical records to EDCs outside the source healthcare institution.
Through this newly developed system, we were able to tackle the above-mentioned challenges, reduce the time of clinical research and trials, and improve the quality of data & efficiency of monitoring operations. In the years to come, we expect to see a further expansion of healthcare institutions adopting this EDC system.

As Remedy & Company’s goal is to further promote digital transformation of clinical trials through further extensive introduction of this next-generation EDC system in healthcare institutions, together with the incorporation of the latest digital technologies such as virtual reality (VR), augmented reality (AR) and artificial intelligence (AI) in the development of instrumentation of clinical trials, we will work towards building our own digital platform for the conduction of clinical trials of higher efficiency and quality, as a part of our business goal in the future.
*Personal information of patients and information of those who are not enrolled in the trials are not included.

Message from Dr. Masayo Takahashi
Consultant at Research Centre, Kobe City Eye Hospital
President, Vision Care Inc.

Kobe Eye Center 's mission is to minimize the time, effort, and cost involved in developing regenerative medicine for retinal diseases, maximize efficiency, and provide better treatments to patients as quickly as possible.Being a hospital that provides general practice service to the local community, there is a struggle when balancing between the role as a hospital and the role as a researcher in the development of new treatments & conduction of clinical trials. We therefore strive to minimize the workload of the doctors and staff members in the hospital. Hence, we believe it would be great to have a system that directly transfers electronic medical records to the central data center, rather than having doctors re-enter clinical trial data from electronic medical records and have the entries checked again by a third party. Although there were various issues and they were quite difficult to understand, thanks to the expertise and effort of Remedy & Company, who were working with a view to the future development of clinical trials and healthcare, we were able to make it work in our facility.
We hope that this technology will become more widely used, so that doctors working in hospitals can concentrate on their patients as much as possible and less effort due to inefficient development will be misspent, thereby leading us to an era of speedy development of treatment.

About Remedy & Company:
Remedy & Company Corporation (formerly intellim Holdings Corporation) was established in 2018. Its predecessor was intellim Corporation and was established in 2005 as a Contract Research Organization. Later in 2018, intellim Holdings Corporation (now Remedy & Company Corporation) was created as the core of operation for intellim Corporation and other group companies in Japan and abroad, to create innovative solutions in drug development.
In April 2022, the company changed its name to Remedy and Company to mark the beginning of reaching the goal of becoming a global health tech platform provider that transcends the boundaries of a CRO.
Remedy & Company presently oversees the operation of the group company intellim Corporation, iRIS Corporation, Quantum Healthcare Corporation and Remedy XR Corporation. Our objective is to promote further growth and advancement of clients, healthcare, and the world, through the utilization of the latest technology and innovation.
The Remedy Group is currently based in nine countries and has projects in 42 countries. (as of 17 Apr 2024)
For more information, please visit:https://www.remedy-company.com/en/