Intralinks® Holdings, Inc. (NYSE: 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.
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