CR Medicon Expands Pharmacovigilance Management Capability in China With Oracle Argus

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CR Medicon Expands Pharmacovigilance Management Capability in China With Oracle Argus

November 18 @ 8:00 am 5:00 pm UTC+0

Nanjing, China Nov. 12, 2019 Nanjing CR Medicon Pharmaceutical Technology CO., Ltd., a Gold level member of Oracle PartnerNetwork (OPN) is collaborating with Oracle Health Sciences to expand their current clinical development offerings with drug safety surveillance and pharmacovigilance services from Oracle Argus. CR Medicon is a subsidiary of Pharmaron, a China-based Clinical Research Organization.

Oracle Argus is an industry-leading solution for safety case management, used to process, analyze, and report adverse event cases originating in pre- and post-marketdrugs, biologics, vaccines, devices, and combination products. 

With China’s global alignment on clinical development and new regulations on drug safety by the National Medical Products Administration (NMPA), Center for Drug Evaluation (CDE) and the National Center for Adverse Drug Reactions (ADR) Monitoring, local and global pharmaceutical companies doing business in China are in need of a reliable drug safety solution that is designed to help meet both international and local regulatory requirements. The collaboration of Oracle Health Sciences and CR Medicon brings the Oracle Argus technology together with CR Medicon’s expertise in pharmacovigilance management to provide a one-stop solution for pharmaceutical and biotech organizations seeking to maintain regulatory compliance, while improving their pharmacovigilance practices.

“By combining Oracle’s Argus safety solution with CR Medicon’s in-depth knowledge in pharmacovigilance, we are positioned to support the rapid growth of clinical trials in China and the compliance requirements that surround them,” said Mr. Henry Wu, CEO, CR Medicon. “In addition, with Oracle’s extensive Oracle PartnerNetwork program, we are very confident that our work with Oracle can maximize the confidence of a growing number of sponsors who demand highly skilled and trained pharmacovigilance professionals and services all optimized on best-in-class technology.”

Through this collaboration, CR Medicon will help its clients to better optimize global compliance and integrate risk management into key processes and regulatory submission, so local and global sponsors can leverage these services and the Oracle Argus solution to help meet their safety and compliance requirements.

“CR Medicon has top-notch drug safety surveillance and pharmacovigilance professionals who can help pharmaceutical and biotech organizations leverage the power of Oracle Argus to support product safety monitoring and compliance with local and global regulatory requirements,” said Mr. Steve Rosenberg, senior vice president and general manager, Oracle Health Sciences. “Together, CR Medicon’s professional services and Oracle’s comprehensive pharmacovigilance technology will equip the industry with what they need to help effectively manage product safety.”

Nanjing CR Medicon Pharmaceutical Technology CO., Ltd ( CR Medicon, http://www.crmedicon.com ), is a China-based clinical CRO company ( a subsidiary of Pharmaron – a global leading life science services company ) that provides comprehensive clinical development services, including regulatory, medical strategy, medical writing, clinical operations, data management & statistical analysis, bioanalytical laboratory, as well as pharmacovigilance solutions for both domestic and overseas companies.

About Oracle Health Sciences

Oracle Health Sciences breaks down barriers and opens new pathways to unify people and processes to bring new drugs to market faster. As a leader in Life Sciences technology, Oracle Health Sciences is trusted by 30 of the top 30 pharma, 10 of the top 10 biotech and 10 of the top 10 CROs for managing clinical trials and pharmacovigilance around the globe.

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Contact

Richard Hoon

Oracle

richard.hoon@oracle.com 

65-90259291

About CR Medicon CR Medicon provides a full range of clinical development services, including drug and equipment registration, medical affairs, clinical operations, biological sample analysis, drug alert, data management and statistical analysis, of which the eCTD system is an integral part of our one-stop clinical CRO services. Since our founding in 2017, CR Medicon has become the clinical CRO partners for nearly a hundred well-known domestic and foreign biotech and pharmaceutical enterprises. CR Medicon team brings together the industry’s experts, has extensive experience in phase I-III new drug clinical, medical device and BE trials. and has been involved in clinical trial monitoring and project management in cutting-edge areas.  

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