ECLEVAR MEDTECH Starts its EU Medical Device Regulation Compliance Support Services for Japanese MedTech Manufacturers

Clinical Research Organization to use Oracle Clinical One as the backbone of its clinical trials

Tokyo, Japan and Austin, Texas—April 11, 2023

ECLEVAR MEDTECH, a global CRO headquartered in Paris, will now provide clinical trial services using the Oracle Clinical One platform to meet the needs of Japanese medical device companies. ECLEVAR MEDTECH will initially focus on clinical trial support services around Medical Device Regulation (EU) 2017/745, (EU MDR) with plans to expand its services to other regions in the future. To gain medical device approval, manufacturers must demonstrate conformity with all relevant aspects of the Medical Device Regulation (EU) 2017/745.

The ECLEVAR MEDTECH Japan office, located in Tokyo, will help Japanese clients meet these compliance requirements by providing technology and local support from representatives experienced in clinical studies and regulatory affairs. Japanese staff on ECLEVAR’s MEDTECH global team will provide additional support.

The CEO of ECLEVAR MEDTECH, Chems Hachani said, “I am pleased that the company is now starting to provide its services to help Japanese medical/IVD manufacturers and I look forward to meeting with Japanese clients in the near future. With our ability to offer clients these new services and the use of Oracle’s leading clinical trial technology, we are enabled to meet the growing needs of our market.”

ECLEVAR MEDTECH joined Oracle’s CRO Growth Initiative in 2022 and it will use the Oracle Clinical One platform to conduct clinical studies, and to collect and analyze clinical and patient data more effectively and efficiently. The Oracle Clinical One platform will make it possible for ECLEVAR MEDTECH to build studies in weeks instead of months, eliminate multiple builds, validations, and complicated integration requirements to streamline workflows. Oracle Clinical One empowers technology companies, sponsors, sites, and regulatory agencies to collaborate and share systems data for clinical studies more easily.

“As organizations turn to CROs to help reduce clinical trial costs and increase collaboration, it’s essential to have the right technology in place,” said Henry McNamara, senior vice president and general manager, Oracle Health Sciences. “Our Oracle Clinical One platform will enable ECLEVAR MEDTECH to use our next-generation data collection technology to consolidate and access the data it needs to conduct clinical studies more efficiently and collaboratively.”

Contact Info

Kazuo Watanabe
Senior Business Development Director, ECLEVAR
[email protected]
070-1254-8686

Judi Palmer
Oracle, Corporate Communications
[email protected]
+1 650 784 7901

About ECLEVAR MEDTECH

ECLEVAR MEDTECH is a CRO specialized in medical/IVD devices and headquartered in Paris, France. The company was founded in 2018 with its mission of making clinical trials more affordable with less time for medical device industries to help lower the entry barriers for medical device companies and with values of being agile and high-quality of services. The company has been supported by the French Government as a start-up business that helps French businesses to be more competitive in the global marketplace. ECLEVAR MEDTECH has a strong and capable team of in-house members with rich experience in clinical studies, senior leaders of a notified body and prominent clinicians who play roles as scientific board members, supporting the company’s mission and values. The company has a network with hospitals and medical institutions in Europe as well as internationally.

Since its establishment, ECLEVAR MEDTECH has provided services such as supporting EU MDR compliance including clinical studies, PMCF, CER to dozens of global and mid-to-small medtech companies.

To learn more about ECLEVAR MEDTEC and Oracle Clinical One, please visit to the following links:

• https://www.eclevarmedtech.com/ja/
• https://www.oracle.com/jp/industries/life-sciences/clinical-research/clinical-one/
• ECLEVAR will attend Medtec Japan April 19-21, 2023: http://www.medtecjapan.com/en

About Oracle Health Sciences

As a leader in Life Sciences cloud technology, Oracle Health Sciences’ Clinical One and Safety One are trusted globally by professionals in both large and emerging companies engaged in clinical research and pharmacovigilance. With over 20 years’ experience, Oracle Health Sciences is committed to supporting clinical development, delivering innovation to accelerate advancements, and empowering the Life Sciences industry to improve patient outcomes. Oracle Health Sciences. For life.

About Oracle

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Source: Cyberpogo