CMIC Holdings and Bayer Yakuhin enter into an agreement to improve the efficiency and quality of clinical trials by leveraging digital technology

September 8, 2021

CMIC HOLDINGS Co., Ltd.

Bayer Yakuhin, Ltd.

CMIC Holdings Co., Ltd. (Head Office: Minato-ku, Tokyo; Chairman & CEO: Kazuo Nakamura; hereinafter “CMIC”) and Bayer Yakuhin, Ltd. (Head Office: Osaka; President: Julio Triana, hereinafter “Bayer Yakuhin”) announced that they entered into a mid to long term agreement aimed at improving the efficiency and quality of clinical trials by leveraging digital technology in August,2021.

In recent years, clinical trials have become increasingly complex, and present many challenges such as collecting and analyzing massive volumes of data and complying with various regulatory requirements. There is a demand to improve the efficiency and quality of clinical trials by leveraging and incorporating new solutions with the aim of developing new drugs more rapidly despite these challenges. In accordance with this agreement, CMIC and Bayer Yakuhin will discuss opportunities for joint research and development as well as carry out medium- to long-term collaborations.

To kick off this collaboration based on this agreement between CMIC and Bayer Yakuhin, in August 2021 CMIC has launched a system at three medical institutions involved in the cardiovascular research  conducted by Bayer Yakuhin which searches for drugs contraindicated for coadministration using its “harmo” electronic prescription records service*. This new functionality in harmo is a safety management system that searches for drugs contraindicated for coadministration and promptly notifies the clinical research coordinator (CRC) when drugs prescribed (dispensed) for a trial participant are entered into harmo.

Coadministration of contraindicated drugs not only threatens the safety of trial participants, but in some cases may greatly impact the entire trial, for example, by making trial data unusable for evaluating the investigated drug. In addition, because each drug has a number of contraindications, the CRC and trial participants must spend considerable time properly identifying and managing them.

This system automatically detects information on all drugs contraindicated for coadministration that CRCs once had to review manually to ensure the safety of trial participants. This feature should prevent accidents due to administration of contraindicated drugs or oversights before they occur and increase trial participants’ awareness of contraindicated drugs.

*Note: harmo electronic prescription records is an electronic prescription record service that links patients, family members, and health care providers. It not only allows users to view medication dispensing history at any time, but also serves as a personal healthcare record (PHR) system that enables individuals to manage their current medications and share information about adverse reactions or other comments with healthcare providers such as pharmacists and physicians.

Keiko Oishi, COO of CMIC Holdings, made the following statement about the agreement:

“I believe that efforts to improve the efficiency and quality of clinical trials by using new means such as digital technology can rapidly bring about new viable solutions not only from pharmaceutical companies alone, but also through collaboration with CDMOs such as CMIC. I have great hopes that this basic agreement with Bayer Yakuhin will bring us one step closer to that.”

Masahito Yamanaka, Head of Clinical Operations, Research & Development Japan of Bayer Yakuhin, said “Clinical trials are the most time-consuming step in the development of pharmaceutical products. To fulfill our mission as a pharmaceutical company to deliver drugs to patients as quickly as possible, it is extremely important to incorporate digital technologies in a flexible manner so that we can conduct clinical trials more efficiently. We believe that our collaboration with CMIC Group, which has extensive experience running clinical trials, will lead to the creation of new value by combining the strengths of both companies.”

About harmo

harmo is a personal health record (PHR) system based on electronic prescription records that has about 400,000 users via the harmo smartphone app or exclusive IC card (as of July 2021) and is used by more than 16,000 pharmacies across Japan, making it Japan’s largest PHR platform. harmo also offers a service called harmo Channel designed to raise awareness of diseases and provide information on the proper use of medications to improve treatment outcomes for patients. In 2020, harmo entered partnerships with two other electronic prescription record services—PHARUMO and Pocket Pharmacy—and is working to develop cross-platform services that utilize prescription records from over a million combined users. Please visit the website of the harmo business for details.

About CMIC group

CMIC Group was founded in 1992 as the first Contract Research Organization (CRO) in Japan. Today CMIC Group is the largest clinical CRO in Japan with global footprint, providing comprehensive services in drug development, clinical site management, manufacturing, regulatory consulting and contract sales & marketing solutions. We can help pharmaceutical, biotech and medical device companies to enter Japan market, to conduct clinical trials in Asia, or to bridge drug development and manufacturing needs in the US, Europe, Japan and broader Asia. CMIC Group has over 7,000 employees and 25 sites globally. For more information about CMIC Group and services, please visit our website. https://en.cmicgroup.com/

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com.

About Bayer Yakuhin, Ltd.

Bayer Yakuhin, Ltd., headquartered in Osaka, is a healthcare company which combines business activities of Pharmaceuticals and Consumer Health. The Pharmaceuticals Division focuses on the therapeutic areas of cardiovascular, nephrology, oncology, ophthalmology, women’s healthcare, hematology and radiology. The Consumer Health Division focuses on prenatal supplements, beauty supplements and a treatment for vaginal yeast infection. Bayer Yakuhin aims to be one of leading pharmaceutical companies, which responds to unmet medical needs for patients in Japan. More information is available at www.pharma.bayer.jp.

【Contact us】

E-mail：pr@cmic.co.jp