OpenClinica EDC Solution Deployed for Retina Implant Studies

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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.

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OpenClinica gives the research sponsor much greater latitude in how they implement and support their systems. This is becoming increasingly important as research grows in expense and complexity.

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. 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 of OpenClinica. "OpenClinica gives the research sponsor much greater latitude in how they implement and support their systems. This is becoming increasingly important as research grows in expense and complexity."

About Retina Implant AG:
Founded in 2003, Retina Implant AG is building upon the results of a research project in which numerous German university hospitals and German research institutes have participated since 1996. The company plans to bring to market the first fully functioning electronic retinal prosthesis, in order to help restore sight to people who have a degenerative retinal disease such as Retinitis Pigmentosa (RP) and Age-related Macular Degeneration (AMD). For more information, see http://www.retina-implant.de/.

About OpenClinica®:
OpenClinica is open source web-based electronic data capture software for clinical research. It facilitates protocol configuration, design of case report forms, clinical data capture, and study/data management. OpenClinica supports HIPAA and 21 CFR Part 11 guidelines and is designed as a lightweight, standards-based, extensible, and modular platform. All versions of OpenClinica are available for download at http://www.openclinica.org.

About Akaza Research®:
Akaza Research, the leading provider of open source clinical trial software, is headquartered in Cambridge, Massachusetts. Supported by the National Institutes of Health (NIH), Akaza has developed and commercialized OpenClinica, the preeminent open source clinical trial data capture and management software platform. Akaza brings Open Source Software (OSS) into the mainstream of the clinical research enterprise by making robust, flexible, standards-based systems accessible for all types of clinical research. Akaza Research provides OpenClinica support, training, and consulting services to its customers worldwide. See http://www.akazaresearch.com.

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Ben Baumann

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