Intralinks and Great Lakes IRB Sign Co-Marketing Agreement
Partnership to Facilitate Information Exchange for Clinical Trials
NEW YORK, July 31, 2007 — Intralinks, Inc., the leading provider of online workspaces for secure document exchange in the life sciences industry, announced today that it has entered into a co-marketing agreement with Great Lakes Independent Review Board (Great Lakes IRB). Great Lakes IRB provides a thorough review of research projects in a timely, efficient manner without compromising the quality of ethical oversight required by the FDA. Under the terms of the agreement, Intralinks will help expedite the flow of information and documents among sites, sponsors and investigators. Great Lakes IRB will use the capabilities of Intralinks as a means to accelerate the clinical trial start-up process.
“Our first priority is the protection of participants in clinical trials,” said James Mulvihill, Founder and President of Great Lakes IRB. “Our partnership with Intralinks will speed the previously time consuming paper-driven study start-up process. With a secure web-based process, we will be able to focus our attention on protecting human subjects while ensuring that safe and effective drugs get to the market.”
Institutional Review Boards (IRBs) play an important role in the clinical trial process by 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 into a clinical trial. Intralinks enables IRBs to share this documentation instantly with sponsors and investigator sites via secure, online workspaces, cutting weeks or months off trial periods. In addition to sophisticated document permissioning tools and security functions, Intralinks online workspaces are designed to comply with the Food and Drug Administration’s 21 CFR Part 11 guidelines.
“We are pleased to have Great Lakes IRB in our network of IRB partners,” said Chris Thomas, Senior Vice President of Business Development for Intralinks. “This relationship will add to the growing list of Intralinks IRB partners that leverage the speed and security of our online workspaces to expedite clinical trials.”
Great Lakes IRB will benefit from the ability to post approval letters online and immediately notify investigator sites and pharmaceutical sponsors. They will also gain a customized template on Intralinks’ service that trial sponsors may use to submit credentials for review.
About Great Lakes IRB
Great Lakes IRB was established as an independent institutional review board (IRB or “Board”) and operates in compliance with CFR 21 parts 50, 56 as well as International Conference on Harmonization (ICH) guidelines for Good Clinical Practices (E6) (GCP). An integral part of the mission of Great Lakes IRB is our commitment to providing study subject protection through education, which allows each potential study subject to make a fully informed decision regarding their participation in a clinical research trial. Great Lakes IRB is based in the Chicago area and uses its location in the Midwest as a strategic advantage to assist in expediting the study start-up process by staffing the IRB operation from 7am – 7pm CST. This creates an opportunity for us to assist sponsors and research sites nationwide during their business hours regardless of their geographic location. At Great Lakes IRB, we are passionate and committed to ensuring that the conduct of clinical research meets the highest ethical standards. . For additional information please contact us at firstname.lastname@example.org or 708-258-3788, or visit our website at www.greatlakesirb.com.