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

Eclevar X ORACLE

ECLEVAR MEDTECH, a Paris-based global CRO, has announced that it will provide clinical trial services using the Oracle Clinical One platform to meet the needs of Japanese medical device companies. 

The company will initially focus on offering clinical trial support services for the EU Medical Device Regulation (EU MDR) 2017/745 and plans to expand its services to other regions in the future. In order to gain medical device approval, manufacturers must demonstrate conformity with all relevant aspects of the EU MDR.

To help Japanese clients meet these compliance requirements, ECLEVAR MEDTECH’s Japan office in Tokyo will provide technology and local support from representatives experienced in clinical studies and regulatory affairs.

Japanese staff on ECLEVAR MEDTECH’s global team will provide additional support.

ECLEVAR MEDTECH’s CEO, Chems Hachani, expressed his pleasure in the company’s ability to provide services to Japanese medical/IVD manufacturers, stating that “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 will use the Oracle Clinical One platform to conduct clinical studies, collect and analyze clinical and patient data more effectively and efficiently.

The platform enables the company to build studies in weeks instead of months and eliminates multiple builds, validations, and complicated integration requirements to streamline workflows.

Oracle Clinical One facilitates collaboration and data sharing among technology companies, sponsors, sites, and regulatory agencies for clinical studies.

According to Henry McNamara, Senior Vice President and General Manager of Oracle Health Sciences, “As organizations turn to CROs to help reduce clinical trial costs and increase collaboration, it’s essential to have the right technology in place.

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.”

To view the complete article on the Oracle website, please click on the link provided.