EP-SOGO bridges pharmaceutical companies as sponsors of clinical trials and medical institutions as clinical sites by providing services to actualize their needs.
- Capabilities as No.1 Site Management Organization
- Wide Variety of Therapeutic Areas
- Systematic Progress Management
- SYNOV-R
a remote SDV-system - Computerizing the Clinical Trial Documents
- Certified Committee for Regenerative Medicine
- Projects Assigned by the Ministry of Health, Labour and Welfare
- High Quality Rater Service
No.1 Total Industry Capabilities
EP-SOGO adresses to a variety of needs for clinical trials regardless of scale or therapeutic area with the most comprehensive network of medical institutions in the SMO industry and CRC support.
Handling Various Fields
EP-SOGO provides the optimal services for various clinical trials ranging from lifestyle-related disease to cancers requiring high professionalism.
Systematic Progress Management
EP-SOGO manages projects by assigning its staff responsible for promoting or managing the
enrollment progress in each branch. Before starting clinical trials, EP-SOGO checks and reviews the enrollment plans devised by CRCs responsible for the sites (clinical trial enrollment plan). During the enrollment period, EP-SOGO leverages its in-house system to identify candid ate information or tasks in a timely manner to check the progress.
In addition to the day-to-day enrollment management, EP-SOGO takes the most suitable measures whenever necessary to fasten the enrollment.
When supporting multiple clinical sites, EP-SOGO regards the clinical trial as a critical project, and a project leader from each branch cooperates with support staff of the headquarters who has extensive CRC experience to implement "Study Start-up", "Subject Enrollment", and "Close-out Management" of the trial.
In-house System and Actions to Promote Enrollment and Ensure Quality Control
SPG-Remote Medical for SYNOV-R, a remote SDV-system
Next-Generation Remote-SDV with a Robust Security and Convenience
SPG-Remote Medical for SYNOV-R is a next-generation remote SDV-system.
The system enables the safe viewing and operation of the medical institution's electronic medical record terminals from outside the hospital, by screen sharing between a viewing PC outside the hospital and a medical record PC inside the hospital. Implementation of the system is as simple as installing a dedicated router in a medical institution.
Advantages of SPG-Remote Medical for SYNOV-R
- SPG-Remote Medical for SYNOV-R improves monitoring efficiency and reduces development costs.
- SPG-Remote Medical for SYNOV-R allows you to view the clinical trial medical records in the same way as you would view them on site (with exactly the same appearance).
- SPG-Remote Medical for SYNOV-R works with all types of electronic medical record systems, not limiting the type of electronic medical record.
- There is no need for costly investment in special equipment and infrastructure for SPG-Remote Medical for SYNOV-R (PC for electronic medical record needs to be provided by the medical institutions).
- Satellite viewing rooms (Remote-SDV implementation room) is available for sponsors at EP-SOGO Co., Ltd. (Tokyo and Osaka).
- Insurance for protection against personal information leakage, which is the first insurance for remote-work products, is included (provided by Mitsui Sumitomo Insurance Co., Ltd.).
For inquiries about installment of SYNOV-R, please contact the salesperson or the following inquiry form:
The Cloud System for Computerized Management of Clinical Trial Documents
Improving the Operational Efficiency and Quality with DDworks NX/Trial Site
Improving Operational Efficiency
DDworks NX/Trial Site improves convenience for reviewing and searching the documents by electronical transfer and archival of the documents. In addition, DDworks NX/Trial Site makes your operation paperless by using the electronic documents as the original.
Improving Reliability and Quality
DDworks NX/Trial Site improves operational quality by computerizing the clinical trial processes, such as in-house workflow of the hospital, IRB administration and inquiries to/from the sponsors.
Please contact our salespersons or use the inquiry form below if you are interested in introducing our system at your site.
Supporting Operation of Certified Committee for Regenerative Medicine
EP-SOGO supports Certified Committee for Regenerative Medicine certified by the Ministry of Health, Labour and Welfare as a committee to review plans to provide Class III regenerative medicine or equivalent including immunotherapy, based on the Act Regarding Ensuring Safety of Regenerative Medicine enforced on November 25, 2014. EP-SOGO undertakes review of PRG therapy, CGF regenerative therapy, cancer immunotherapy, etc. Also, feel free to ask us about procedures to initiate regenerative medicine projects. Please contact us via the contact form.
The Ministry of Health, Labour and Welfare commissioned Project to Improve and Promote Review Capability of Certified Review Board to EP-SOGO
The Ministry of Health, Labor and Welfare (MHLW) project in FY 2018 and FY 2019. Labour and Welfare commissioned Project to Promote Improvement in Reviewing Skill of Certified Review Board to EP-SOGO.
This project aims to enhance the chairperson’s role of the Certified Review Board for Clinical Research (CRB) and improve the quality of reviews and advisory tasks, as well as to standardize procedures in each certified committee for improvement of convenience in researchers’ point of view.
Supports Provided by EP-SOGO
High Quality Rater Service
EP-SOGO dispatches clinical psychologists with extensive experience and advanced expertise to clinical sites to support smooth progress of administering rating scales in clinical trials in psychiatric and CNS areas.