Expansion and partnership of industry leaders creates a new force in Japanese marketplace
MEDIFACTS INTERNATIONAL, INC. a leading global cardiovascular core lab and SUZUKEN CO. Ltd - one of Japan’s largest cardiac safety services providers today announced the formation of a strategic alliance to deliver advanced technology and centralized cardiac safety testing services to the biopharmaceutical and medical device industry in Japan. Regarded as the world’s third largest geographic market for pharmaceutical development, companies in Japan now have access to leading cardiac safety monitoring technology and services for the management of their clinical trials.
The combination of Medifacts International and Suzuken, the leading Japanese pharmaceutical services, equipment and distribution company, brings together Medifacts’ industry-leading scientific and regulatory expertise, global logistics and support infrastructure with Suzuken’s established presence and leadership in the Japanese marketplace to create a potent new force in Asia.
The alliance will provide the most comprehensive and localized logistics, site support and data management in Asia for central electrocardiogram (ECG) and ambulatory blood pressure monitoring (ABPM) collection services. Operating from centers in Nagoya, Sapporo and Tokyo as well as two sites in Shanghai, China, the alliance will provide over 200 personnel - including a field support force of 130 equipment experts - from five shared facilities supporting cardiac safety studies across Asia.
Michael Woehler, President and CEO of Medifacts said: “We are delighted to be working with an organization of the quality, expertise and reputation of Suzuken. Our strategic alliance sets a new standard in the service delivery of Japanese as well as global studies; and we are now able to provide our global clients with full service cardiac safety support operating from hubs in Japan, China, Europe and the Americas.”
Commenting on the alliance, Boaz Mendzelevski, MD, Medifacts’ Director of Cardiology and consultant to the pharmaceutical industry remarked, “With the impending adoption of ICH E14 guidelines in Japan: Japanese and global biopharmaceutical companies are going to be confronted with an immediate need to address complex new regulations across the entire range of development activities. Medifacts’ uniquely diverse global experience in ECG, Blood pressure and haemodynamics coupled with Suzuken’s extensive experience in Japan are perfectly positioned to assist biopharmaceutical companies navigate new and varied regulatory and scientific requirements in a fast and cost efficient manner.”
About MEDIFACTS
MEDIFACTS is a global leader, providing unparalleled quality Cardiac Safety and Efficacy services since 1985 to pharmaceutical, biotech and medical device companies engaged in the development of therapeutic drugs and related products.
MEDIFACTS provides ECG and Holter collection, management, and analysis services as well as automated Office, Home, and Ambulatory Blood Pressure, Blood Glucose, Spirometry and Pulse Wave Monitoring services from its offices in the US, South America, Europe, and Asia. Medifacts maintains the world’s largest database of ABPM profiles and has managed more protocols using this technology than any other company in the world.
Driven by best-in-class Science, Technology, and Quality System Management, MEDIFACTS’ Core Lab has maintained strong growth and the company is now established as one of the top three providers in its industry. The combination of MEDIFACTS’ scientific expertise, proprietary WebHeart® technology, global presence and recognized quality leadership have led to the company being selected as the partner of choice by pharmaceutical and biotech drug developers around the world.
WebHeart® is a proprietary, global, Web-based platform that offers a complete solution to acquiring, displaying, measuring, and managing Cardiac Safety data in clinical trials. This system allows for real-time access to ECG and Ambulatory Blood Pressure data. Because no actual programming is required, the time and cost of both study setup and data submission are dramatically reduced. ECG data can be converted into an XML format that meets FDA requirements and protocol setups are easily configured and expanded to accommodate additional information.
About Suzuken
Suzuken's core business is pharmaceutical distribution. As a leader in the field, Suzuken delivers ethical pharmaceuticals for patients, diagnostic reagents and medical equipment safely and reliably to medical institutions and pharmacies. The Suzuken Group's collective capabilities encompass pharmaceutical distribution and beyond, spanning the full range of healthcare-related fields. Companies in the group include Sanki Clinical Link Co., Ltd. (clinical testing services), Sanwa Kagaku Kenkyusho Co., Ltd. (pharmaceutical manufacturing), Kenzmedico Co., Ltd. (medical equipment manufacturing), HMS Co., Ltd. (medical practice consulting), Life Support Co., Ltd. (insurance consulting), and Life Medicom Co., Ltd. (medical publishing and advertising).
The Suzuken Group spans Japan and also includes Suzuken Okinawa Yakuhin Co., Ltd., Suzuken Iwate Co., Ltd., Nakano Yakuhin Co., Ltd. (Tochigi Prefecture), Sanki Corporation (Chugoku region), ASTIS Co., Ltd. (Shikoku), and Shoyaku Co., Ltd. (Kyushu). Suzuken plays a central role in Japanese pharmaceutical distribution with the nationwide network of sales offices of these group companies.
Contacts:
Medifacts International, Inc.
Jennifer Grigonis
Phone:
+1 301-795-2508
jgrigonis@medifacts.com
www.medifacts.com
or
SUZUKEN
Co., Ltd.
Tatsumi Shimada
Kenz Product Dpt.
Phone:
+81-3-3917-2501
ta.shimada@suzuken.co.jp
www.suzuken.co.jp
or
Press
Contact
Agency Moritz
Preston T. Moritz
215-605-0993
preston@agencymoritz.com
www.agencymoritz.com