German medical device company, Retina Implant, AG has selected OpenClinica as its electronic data capture (EDC) and clinical data management (CDM) system to power its clinical trials.
Ruetlingen, Germany (PRWEB) August 20, 2008 -- German medical device company, Retina Implant, AG has selected OpenClinica as its http://www.openclinica.org/section.php?sid=1 [electronic data capture (EDC) __title__ EDC software] and clinical data management (CDM) system to power its clinical trials. The company's primary product is a novel retinal prosthesis that in many ways is analogous to the popular cochlear implant used as a hearing prosthesis. The device will primarily be used to treat Retinitis Pigmentosa (RP) and Age-related Macular Degeneration (AMD).
"We are currently using OpenClinica for 11 trials with sites in Germany, India, and Brazil, and we plan to use it for new studies with sites in the U.S. as well," said Anusch Hekmat, VP of Quality Management & Regulatory Affairs at Retina Implant. "As a small medical device company, the professional open source approach behind OpenClinica makes a lot of sense. It allows us to be highly adaptable in how we administer our clinical trials while providing us with high quality professional support in key areas."
Selecting, implementing, and supporting a sound, regulatory compliant system for clinical trial data management can be challenging for smaller biotech companies. Retina Implant is among numerous other biotech and pharmaceutical companies who enjoy the flexibility and compelling value of a professionally supported open source solution.
"OpenClinica removes many of the constraints that proprietary vendors tend to put on their clients," said Ben Baumann, Director of Business Development at Akaza Research, the creators o
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