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Hanmi Selects the Medidata Clinical Cloud for Faster Data Capture and Better Operational Oversight o

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By Business Wirevia The Motley Fool

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Hanmi Selects the Medidata Clinical Cloud for Faster Data Capture and Better Operational Oversight of Clinical Trials

Korean Pharma Implements Medidata Rave for Improved Site Productivity and Enhanced Data Management

NEW YORK & SEOUL, South Korea–(BUSINESS WIRE)– The Medidata Solutions (NAS: MDSO) platform has been selected by Hanmi Pharmaceutical Co., Ltd., a leading Korean pharmaceutical company, to support data collection and management in Phase I and II oncology clinical trials. Following a recommendation from LSK Global PS, a Medidata Services Partner and Korean contract research organization (CRO) providing clinical trial services to Hanmi, the life science organization selected the industry-leading Medidata Rave® system for electronic data capture, management and reporting.

Hanmi’s choice of the Medidata Clinical Cloud™ supports the company’s wider initiative to improve workflows and productivity while developing new therapies. In particular, Hanmi anticipates that its use of Rave will enhance site productivity through real-time data entry in an intuitive user interface and will also help streamline trials through Rave’s timely reporting capabilities and smooth handling of mid-study protocol amendments.

  • “Hanmi’s commitment to efficiently providing new innovative drugs across a number of therapeutic areas is reinforced by their adoption of the Medidata Clinical Cloud,” said Glen de Vries, president, Medidata Solutions. “By tapping into the effectiveness of next generation technologies, Hanmi is showing its dedication to safely expedite R&D to help bring drugs to waiting patients faster.”

By implementing Rave, the company also anticipates that more timely access to data for analysis will support better trial oversight and more informed and earlier decision making. Additionally, Hanmi anticipates better study start-up through Rave’s reusable study assets and its standards-based integration framework that facilitates rapid integrations with other systems to enable data sharing.

  • “Medidata’s reputation for streamlining clinical trials and enhancing trial decision making was a major factor in our decision to select the Medidata platform,” said Jeewoong Son, senior vice president, Hanmi. “Medidata’s commitment to designing cloud-based solutions that enhance research team productivity through user-friendly interfaces will play a role in driving efficiencies in our drug development programs and reducing the total cost of our clinical development.”

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Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Medtentia International and clinicalprojects international Tap BioClinica for Express EDC, Data Mana

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By Business Wirevia The Motley Fool

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Medtentia International and clinicalprojects international Tap BioClinica for Express EDC, Data Management, and Centralized Imaging Reads


International Experience, Flexibility, and Speed to Support Innovative Cardiac Device Research

NEWTOWN, Pa.–(BUSINESS WIRE)– BioClinica®, Inc. (NAS: BIOC) , a global provider of clinical trial management solutions, today announced an agreement for BioClinica Express EDC, data management, and imaging core lab services with Finnish company Medtentia International, in partnership with the contract research organization (CRO) clinicalprojects international (CPI). Medtentia International Ltd. is a medical technology company which develops solutions for mitral valve repair based on its proprietary helix ring concept. Medtentia’s technology has the potential to reduce the invasiveness, operation time and morbidity associated with mitral valve repair operations.

Medtentia is the latest European customer to select BioClinica eClinical and Imaging Core Lab offerings. BioClinica services will support Medtentia’s multi-country, multi-year study of a medical device for mitral valve (heart) repair. “We awarded this clinical trial to CPI and BioClinica based on the excellent feedback we received from their reference clients,” commented Olli Keranen, CEO of Medtentia. “We were already familiar with BioClinica’s Imaging Core Lab solutions and wanted to outsource EDC and DM to a stable global eClinical vendor. We are confident that both companies’ reputations for customer focus and respective strengths will well serve the needs of an innovative medical device company like Medtentia.”

Based in Bonn, Germany, CPI is focused on the planning and execution of Phase I-IV as well as post-marketing studies for innovative medical devices, combination products and (Bio)Pharmaceuticals. “We are delighted that Medtentia has entrusted us with their trial and look forward to another successful collaboration with the BioClinica team,” said Jörg Breitkopf, Managing Director of CPI. “BioClinica has a strong service and technology reputation among medical device companies. Our partnership will provide Medtentia with the utmost in clinical trial support.”

“BioClinica’s fresh and more cost-efficient approach to clinical trial support is currently driving unprecedented sponsor and CRO partnership growth across both eClinical and Imaging Core Labs solutions,” said Mark Weinstein, CEO of BioClinica. We continue to expand our team, especially in Europe, adding to our experience and global reach, and are pleased to have been selected to help support this important cardiac device research.”

Follow BioClinica on the Trial Blazers blog at http://info.bioclinica.com/blog, and on twitter at http://twitter.com/bioclinica.

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Source: FULL ARTICLE at DailyFinance