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IntraLinks and Copernicus Group IRB Sign Co-Marketing Agreement Strategic alliance to speed clinical trials
New York, March 23, 2005 IntraLinks, Inc., a leading provider of secure on-demand workspaces to the life sciences industry, today announced that it has entered into a co-marketing agreement with Copernicus Group IRB, an Independent Institutional Review Board. Copernicus Group protects the rights and welfare of human research subjects involved in clinical drug trials. Under the terms of the agreement, IntraLinks will help expedite the flow of information among members of the pharmaceutical community and Copernicus Group will leverage IntraLinks' drug development hub to speed the clinical trial process.
"Our first duty is to protect subjects involved in clinical trials," said Sharon Hill Price, Founder and Chief Executive Officer at Copernicus Group IRB. "Working with IntraLinks will allow us to streamline the study start-up process. In turn we will be better able to focus our attention on issues of importance to the protection of human subjects and perhaps speed the time it takes for a safe and effective drug or device to get to market."
Institutional Review Boards (IRBs) play a critical role in the clinical trials process, serving as independent or institutional committees charged with protecting the rights, safety and well-being of human subjects. As a part of that process, IRBs review documentation submitted by pharmaceutical sponsors and investigator sites prior to the introduction of subjects to a clinical trial. IntraLinks enables IRBs to share this documentation online with sponsors and investigator sites via secure, electronic workspaces, cutting weeks or months off trial periods. In addition to sophisticated document permissioning tools and security functions, the workspaces are designed for compliance with the Food and Drug Administration's 21 CFR Part 11 guidelines. Copernicus Group is the sixth IRB to partner with IntraLinks, joining Chesapeake Research Review, Inc., Coast IRB, Quorum Review IRB, Schulman Associates IRB, and Western IRB.
"We are pleased to add Copernicus Group to our network of IRB partners," said Richard Jenkins, Vice President of Business Development for IntraLinks. "Further integrating our services into the pharmaceutical community will make the site initiation process more efficient."
Using IntraLinks, Copernicus Group will be able to replace time-consuming paper driven processes with a secure, electronic process. Approval letters are able to be posted online, with investigator sites and pharmaceutical sponsors notified immediately via email alerts. Each of IntraLinks' IRB partners has a specific template on the IntraLinks service for trial sponsors to use when submitting credentials for review.
About Copernicus Group IRB Copernicus Group IRB was established in July 1996 as an independent institutional review board (IRB or "Board") and operates in compliance with Federal Regulations governing institutional review boards set forth in 21 CFR, 45 CFR and ICH GCP Guidelines. Copernicus Group IRB is also a member of the Consortium of Independent Review Boards (CIRB), which regularly meets with OHRP and FDA staff to review issues of importance to the protection of human subjects involved in clinical research. In August of 1999, the Copernicus Group IRB was inspected by the FDA and was not issued an FDA Form 483. In July of 2004, Copernicus Group IRB was awarded full accreditation of our Human Research Protection Program by AAHRPP®, The Association for the Accreditation of Human Research Protection Programs, Inc.
Copernicus Group IRB offers top notch personalized service and proven processes that support community hospitals, academic institutions and large multi-site trials in the research enterprise. With multiple meetings per week and an educational website available at http://www.cgirb.com, Copernicus Group IRB is an ideal partner in the protection of human research subjects.
About IntraLinks IntraLinks (www.intralinks.com), a leading provider of on-demand workspaces, connects business communities and accelerates the intelligent flow of information and documents among participants. Through IntraLinks' secure, neutral, online environments, companies are better able to compete globally by accelerating essential business processes, simplifying communication and fostering rapid workflow. IntraLinks is easily accessible anywhere, anytime using a web browser.
Since April 1997, more than 200,000 participants representing over 10,000 organizations worldwide have used IntraLinks on-demand workspaces to communicate and collaborate on more than 20,000 projects and transactions. IntraLinks has been rapidly adopted by the financial services and pharmaceutical markets. Over 250 global companies are IntraLinks clients, including AstraZeneca Pharmaceuticals LP, Bank of America, Bear Stearns, Deutsche Bank, Ernst & Young, FDIC, JPMorgan Chase, TD Securities, Thomas Weisel Partners and WestLB. Founded in June 1996, IntraLinks is headquartered in New York with offices in Boston and London.
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