June 16, 2021

Next-Generation Remote Source Document Verification (R-SDV)
System to Streamline and Accelerate Clinical Trial Operations

EP-SOGO Co., Ltd. (Head Office: Shinjuku-ku, Tokyo, CEO: Kenichi Yamamoto,hereinafter referred to as "EP-SOGO") and BitBrain Corporation (Head Office: Fukui
City, Fukui Prefecture, CEO: Tomomi Saito, hereinafter referred to as "BitBrain")have jointly developed a Remote-SDV system to realize direct access to source
documents (R-SDV) from outside of medical institutions for monitoring clinical trials.
The system, named "SPG-Remote Medical for SYNOV-R" is based on thecurrently available, highly secure, remote access solution for medical institutions"SPG-Remote Medical".

【 Backgrounds 】
SDV (Source Document Verification) refers to the direct inspection of source
documents such as medical records and worksheets stored by medical institutionsin clinical trials conducted by pharmaceutical companies to verify the submitted data(case report forms) against the records in the source documents. This is an
important part of the monitoring process and is essential for establishing thereliability of a clinical trial.
On the other hand, due to the global spread of the new coronavirus pandemic since2020, it has become difficult for Clinical Monitors to visit medical institutions toconduct SDV, making it harder to ensure the reliability of clinical trial data. It has
been expected that safe and convenient R-SDV will be available to solve this problem.
Since the "Five-Year Plan for Revitalizing Clinical Research and Clinical Trials of 2012"(March 30, 2012, Ministry of Education, Culture, Sports, Science and Technology
and Ministry of Health, Labour and Welfare) proposed the promotion of RemoteSource Document Verification (R-SDV), various organizations and companies havebeen working on the development of such systems. However, introduction of R-SDV
has been slow due to high hurdles such as cost and infrastructure.

【 Overview of SPG-Remote Medical for SYNOV-R 】【 Features of SPG-Remote Medical for SYNOV-R 】➢SPG-Remote Medical for SYNOV-R allows you to view the medical records in thesame way as you view them on site (with exactly the same information andappearance).

➢SPG-Remote Medical for SYNOV-R works with all types of electronic medicalrecord systems. Many of the other R-SDV systems currently on the market arelimited to certain types of electronic medical records.

➢There is no need to invest in special equipment and infrastructure for SPGRemote Medical for SYNOV-R *Note: The operating PC (SDV terminal) needs to beprovided by the medical institution.

➢A satellite viewing room (R-SDV implementation room) is available at EP-SOGO(Shinjuku-ku, Tokyo).

➢

SPG-Remote Medical is the first remote-work product in Japan to include
insurance for protection against personal information leakage (provided byMitsui Sumitomo Insurance Co., Ltd.).

【 Overview of SPG-Remote Medical 】
SPG-Remote Medical, the basis of SPG-Remote Medical for SYNOV-R, is asystem that enables the safe viewing and operation of hospitals’ electronic medical
record terminals on an isolated network from outside the hospital. Implementationof the system is as simple as installing a dedicated router in the isolated networkand requires no construction work in the hospital. The networks of the electronic
medical record networks of the hospital and the terminal outside the hospital are
physically separated, and screen sharing is done securely.
SPG-Remote Medical is a remote desktop solution for medical institutions that has
been highly evaluated for its robust security, ease of installation and ease ofoperation.

【 Future developments 】
EP-SOGO has started pilot operation of SPG-Remote Medical for SYNOV-R at fivesites in Hokkaido, Tohoku, Chushikoku, Kyushu. Based on the results of thisverification, EP-SOGO will further improve the system, enhance its functions, androll-out the system nationwide throughout Japan by the end of this year.
EP-SOGO plans to expand the satellite viewing rooms to its offices in the Osaka
area as well, and to enable R-SDV at clinical trial sponsors’ premises in order tomeet the demands of even more customers.

【 Comments from each company 】｜Shunichi Takamatsu
Deputy General Manager, Business Planning & Promotion Department, Business
Planning & Promotion Division, EP-SOGO Co., Ltd.
EP-SOGO is aggressively pursuing the streamlining of clinical trial operations byutilizing cutting-edge information technology, and has, since last year, been
providing electronic central IRB and clinical trial progress management systems
for medical institutions.
This SPG-Remote Medical for SYNOV-R system will be one of the products inthis business lineup, and we believe that we will be contributing to theacceleration of clinical development in Japan by providing this service not onlyto EP-SOGO partner medical institutions, but also to other medical institutions
conducting clinical trials nationwide.
Through this business alliance with Bitbrain, we will not only improve the SDV
environment in response to the impact of the new coronavirus epidemic, butalso aim to provide innovative solutions and services to further improve theclinical trial implementation environment of the future.

｜Tomomi Saito
Representative Director, BitBrain Inc.
BitBrain is well versed in cutting-edge technologies for advanced networking
and security. By creating products and services based on these technologies
and distributing them in society, we aim to solve business and social issues andbring about better changes in society.
By delivering "SPG-Remote Medical for SYNOV-R", developed through thebusiness alliance with EP-SOGO, as a remote access tool to medical institutions
nationwide, we will contribute to society by providing a clinical trial
implementation environment that reduces the burden on those involved inclinical trials in the future.

About EP-SOGO Co., Ltd. (https://www.epsogo.co.jp/en/)
EP-SOGO, which is responsible for the implementation and operation of this system,
is the largest SMO company in Japan, covering many disease areas on a nationwide
scale. 1,200+ CRCs (Clinical Research Coordinators) and SMAs (Study ManagementAssistants) are supporting more than 1,500 medical institutions from Hokkaido toOkinawa (more than 6,000 are partnered). In addition to oncology, which is the EPSGroup's forte, our professionally trained staff provide comprehensive support forclinical trials at medical institutions in fields ranging from dermatology, orthopedics,
and lifestyle-related diseases to medical devices and regenerative medicine.

About Bitbrain Corporation (https://bit-brain.jp/)
Bitbrain, which is responsible for the development and technical support of thissystem, is a company that specializes in cutting-edge network and securitytechnologies. The SPG-Remote series, which we develop and market, is a remote
desktop tool with various security features and network isolation functions. Due toits high level of security, it has been installed in financial institutions and hospitals,
and has been featured in various media. It was awarded a special prize for its highsecurity in the "Kansai Manufacturing Innovation 2021" sponsored by the Kinki
Bureau of Economy, Trade and Industry of the Ministry of Economy, Trade, andIndustry.

≪ Contacts ≫EP-SOGO Co., Ltd.
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo 162-0821, Japan
E-mail：remote-sdv@epsogo.co.jp
Tel: +81-3-4218-3500 (main number)