The Contract

On August 2, 2010 DATATRAK International, Inc. (DATA) announced that DAIICHI SANKYO EUROPE GmbH selected DATATRAK’s eClinical platform for a cardiovascular clinical study encompassing 80 sites and 1,200 patients across Europe.

Reaping the benefits of a unified platform, DAIICHI SANKYO EUROPE GmbH will utilize DATATRAK’s Electronic Data Capture solution in addition to web-based Patient Randomization, Drug Inventory Management, Lab Import and Auto-Coding Engine solutions. Also, study users will be able to view, manage and report on patient data via DATATRAK’s dynamic, ad-hoc reporting module. As with all studies for this sponsor, DATATRAK will be producing CDISC SDTM compliant exports throughout the study.

The Players

DATATRAK International, Inc. is a technology and services company that provides electronic clinical solutions for the clinical trials industry. Its software suite is used to collect, review, transmit, and store clinical trial data electronically.

DAIICHI SANKYO is a global pharmaceutical company that focuses on research and the marketing of innovative medications. The company was created in 2005 through the merger of two traditional Japanese enterprises, Daiichi and Sankyo. With net sales of nearly €7.3 billion in fiscal year 2009 (as at March 31st), DAIICHI SANKYO is one of the world’s 20 leading pharmaceutical companies.

Quoted

“We have decided to use DATATRAK because the unified platform appealed to our needs. The ease in which for example IWRS or study drug management can be utilized with EDC within one solution will bring us significant benefit throughout the study. Furthermore, the built-in data export routines to SDTM and flexible ad-hoc reporting tools supporting our efforts in process control,” said Paul-Egbert Reimitz, Director of Biostatistics and Data Operations at DAIICHI SANKYO EUROPE GmbH.

“We are delighted to have been awarded this new study by DAIICHI SANKYO EUROPE, whose adoption of DATATRAK ONE™ is a testament to both teams’ hard work and success in implementing complex international clinical trials,” said Laurence P. Birch, DATATRAK’s Chairman of the Board. “We remain focused on providing our clients the benefits of increased patient safety, real-time data availability and management in addition to a completely unified user experience, ranging from investigative sites to Sponsors and CROs.”

 
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