Nov 30 2010
DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today publically congratulated its sponsor partner Cosmo Pharmaceuticals S.p.A. (SIX: COPN) who last week announced positive top-line results from their second pivotal Phase III clinical study which was conducted in the EU utilizing DATATRAK's unified eClinical product suite and services team to evaluate the safety and efficacy of budesonide MMX® for the induction of remission of mild or moderate ulcerative colitis. In late September, Cosmo Pharmaceuticals and Santarus also announced positive top-line results from the Phase III clinical study of budesonide MMX® in North America and in India.
"We are very pleased with the budesonide MMX® clinical trial results. We conducted the clinical trials in 177 sites in 19 countries. Being a small company of limited personnel resources, DATATRAK provided an efficient solution that allowed us to have a detailed overview of the progress of the trial at all times," said Mauro Ajani, CEO of Cosmo Pharmaceuticals.
"We congratulate Cosmo on their impressive results with budesonide MMX®, and we sincerely appreciate the positive comments from their team of investigators and end users about the DATATRAK experience," said Laurence P. Birch, DATATRAK's Chairman and CEO. "Cosmo has been a proponent of DATATRAK and its product suite, and we have thoroughly enjoyed our supportive relationship in completing these trials."
Over the past two years, DATATRAK and Cosmo have worked together to successfully complete these two pivotal studies. Cosmo utilized the electronic data capture, lab data import and medical coding components of the DATATRAK eClinical™ solution. For more information on Budesonide MMX®, please visit Cosmo's Product Pipeline page.
SOURCE DATATRAK International, Inc.
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