Commercial open source clinical trials software demonstrates value to manufacturer of medical devices.
Waltham, MA (PRWEB) December 10, 2010
Australia-based Advanced Surgical Design & Manufacture Ltd. (ASDM) and U.S.-based Akaza Research, LLC announce that ASDM has selected Akaza's OpenClinica technology to power ASDM's clinical trials. OpenClinica is software for electronically collecting and managing clinical trial data and is provided under an innovative commercial open source model.
ASDM is a global manufacturer of medical devices including orthopaedic and vascular products. The company's cutting-edge product range has an extensive clinical history going back to 1992. The company has a portfolio of well established products as well as a comprehensive research and development program including promising collaborations with companies, university research groups and surgeon inventor/innovators. These collaborations are yielding new orthopaedic and medical device innovations that may see commercialisation over the next several years.
ASDM plans to use OpenClinica to support an existing Phase II clinical trial of the CE marked class II Peripheral Access Device (PAD). The PAD will be trialled in a novel treatment modality indicated for patients suffering from critical limb ischemia and at immediate risk of amputation called Hypertensive Extracorporeal Limb Perfusion (HELP). Plans are also underway to utilise the OpenClinica software to capture post market data on existing ASDM products such as the Active Knee range of orthopaedic implants.
"We identified OpenClinica as the most cost effective software solution to help us conduct our clinical trials most productively," said Dr. Greg Roger, ASDM CEO. "Its powerful capabilities, multiple study flexibility and in house hosting and configurability allows us to adapt to changes quickly and effectively which we couldn't find elsewhere."
About Advanced Surgical Design & Manufacture (ASDM)
Advanced Surgical Design & Manufacture Limited (ASDM) is a listed company on the Australian Securities Exchange. Since its establishment in 1994, the company has had a strong commitment to research, product development and engineering excellence, which is evident in its extensive product portfolio and a large number of awards.
ASDM designs, engineers and manufacturers medical devices including a well respected and comprehensive orthopaedic product range, including the Active Knee - along with associated instrumentation. Ancillary capabilities include a large variety of bone screws and also bone saw blades. Regulatory approval (Australia and Europe) of the PAD device highlights the culmination of ASDM's expansion in to the vascular arena with continued rapid development in this field underway. ASDM's focus is to provide the best possible health care solutions to patients world-wide, through harnessing the innovative potential of Australian inventors and clinicians. For more information see http://www.asdm.com.au.
OpenClinica is open source, web-based clinical trials software for electronic data capture (EDC) and clinical data management (CDM). OpenClinica facilitates study protocol configuration, data collection via electronic case report forms (eCRFs), and enables productive clinical trials management. OpenClinica supports HIPAA, 21 CFR Part 11, and other regulatory guidelines and is designed as a standards-based, extensible, and modular platform. The OpenClinica Community (free) and Enterprise (commercial) Editions provide a dramatically lower cost of ownership when compared with alternative proprietary technologies. For more information (including product downloads) visit http://www.openclinica.org or follow @OpenClinica on Twitter.
About Akaza Research®
Akaza Research is the provider of the leading open source clinical trial software, OpenClinica. Trusted by hundreds of biopharmaceutical companies, contract research organizations, academic, and government organizations worldwide, Akaza's professional open source model brings Open Source Software (OSS) into the mainstream of today's clinical research enterprise. The company provides commercial support to its OpenClinica customers across six continents servicing clinical studies of all types and sizes.