Intralinks Improves Efficiency and Compliance for Clinical Trial Sites with Electronic Investigator-Controlled Site Files

NEW YORK, June 10, 2014 /PRNewswire/ -- Intralinks® Holdings, Inc. IL, a leading, global SaaS provider of inter-enterprise content management and collaboration solutions, today announced the availability of its electronic investigator-controlled site file (eISF) solution, a simple online document storage tool for investigator sites involved in the clinical trial process. The new solution is designed to dramatically improve regulatory compliance and efficiency at the investigator site while revolutionizing how sponsors can maintain oversight of participant sites by enabling study monitors and inspectors to no longer have to view investigator documents in person.  

In the last decade, life science companies have invested heavily in electronic trial master file (eTMF) systems and other workflow and document management tools to improve the collection, filing and submission of all relevant clinical study documentation. However, eTMF technology and processes are focused on the trial sponsor and driven by study milestones. These systems are poorly suited for extension to investigator sites because regulations require that each site involved in a clinical trial maintain their own independent study binders in order to provide confirmation of the sponsor's conduct, compliance and the integrity of the trial.

Investigator sites must maintain full control over their investigator site file (ISF), and even decades after the trial is over the sponsor must ensure that agreements are in place to ensure the availability of these binders for inspection without ever having uncontrolled access. As a result, over 80% of site-based documentation is still fully paper-based with both cost and risk consequences for the entire clinical trial process.

"For large complex phase III studies, monitoring of study sites is typically the single largest study expense, often accounting for 30% of the entire study budget," said Andrew Mitchell, director of product strategy and marketing at Intralinks. "As an industry seeking to increase efficiency and reduce costs, we should not just be looking to reduce the number of visits based on risk-based monitoring calculations when half the duration of those visits is spent reviewing documents. Providing sites with an eISF solution that grants controlled, remote access to sponsors (and inspectors) reduces risk, improves site compliance and efficiency and saves monitor time at the sites, reducing the travel burden to provide massive cost savings."

Intralinks eISF is designed to securely store all of the documents for each site across studies and sponsors, while helping to ensure the investigator  maintains control even when sharing sensitive content. In addition, sponsor eTMF filing is improved by prioritizing content received from sites' eISF based on metadata, and the improved quality of the site documentation will have undergone a more rigorous review process.

With more than 2,100 active clinical studies running on Intralinks Studyspace, over 60,000 investigator site users already use Intralinks to assist them with clinical trial documentation.

For more information, visit http://www.wherepartneringworks.com/.

About Intralinks
Intralinks Holdings, Inc. IL is a leading, global technology provider of inter-enterprise content management and collaboration solutions. Through innovative Software-as-a-Service solutions, Intralinks solutions are designed to enable the exchange, control and management of information between organizations securely and compliantly when working through the firewall. More than 2.7 million professionals at 99% of the Fortune 1000 companies have depended on Intralinks' experience. With a track record of enabling high-stakes transactions and business collaborations valued at more than $23.5 trillion, Intralinks is a trusted provider of easy-to-use, enterprise strength, cloud-based collaboration solutions. For more information, visit www.intralinks.com.

Forward Looking Statements
The forward-looking statements contained in this press release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements are express or implied statements that are not based on historical information and include, among other things, statements concerning Intralinks' plans, intentions, expectations, projections, hopes, beliefs, objectives, goals and strategies.  These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control and could cause actual results to differ materially from those contemplated in these forward-looking statements. Accordingly, there can be no assurance that the results or commitments expressed, projected or implied by any forward-looking statements will be achieved, and readers are cautioned not to place undue reliance on any forward-looking statements. The forward-looking statements in this press release speak only as of the date hereof.  As such, Intralinks undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For a detailed list of the factors and risks that could affect Intralinks' financial results, please refer to Intralinks public filings with the Securities and Exchange Commission from time to time, including its Annual Report on Form 10-K for the year-ended December 31, 2013 and subsequent quarterly reports.  Intralinks undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

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"Intralinks" and Intralinks' stylized logo are the registered trademarks of Intralinks, Inc. "Intralinks Studyspace" is a trademark of Intralinks, Inc. This press release may also refer to trade names and trademarks of other organizations without reference to their status as registered trademarks.  © 2014 Intralinks, Inc.  All rights reserved.

SOURCE Intralinks Holdings, Inc.