October 16, 2014 at 11am EDT
5pm CET / 4pm (GMT)

Sponsored by

Webinar Description:

Across the industry, companies are striving to find ways to improve operational efficiencies. Currently, over 80% of site-based documentation today is still fully paper based, with both cost and risk consequences for the entire clinical trial process. Specific liabilities include audit and inspection risk, reduced site productivity, manual reconciliation of TMF and site records, lack of visibility into site performance.

In this talk we will examine how to avoid these inefficiencies in today’s clinical trial process as well as disruptive onsite monitor visits to verify documentation. 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. As you may know the cost of sending one monitor to a site is typically around $5,000 per day, and typically at least half the duration of those visits is spent reviewing documents.

Join Intralinks’ Andrew Mitchell for a live, online discussion about replacing manual paper-based procedures and implementing secure offsite document access and management. You’ll come away with a better understanding of options for managing site documentation, maintaining control for the investigator, optimizing monitor site visits, and ensuring long-term document availability for inspection.

Learning Objectives:

• Never reconcile versions of documents in ISF and TMF: Help Sponsors and TMF teams to improve the quality of incoming documentation from the sites.
• Long-Term Archival: Reduce storage costs and effort through a simplified filing system for paper originals (wet ink signatures) and have electronic binders available on-demand.
• Enable CRAs to review documents remotely having access to all study documents without disruptive onsite visits. Helps for perfect preparation for site visits and reduces risk and burden on individual monitors by providing access to additional users.
• Be ready for inspections, utilize summary and completeness reports as well as directly access previous versions of documents. Sponsors gain pre-onsite inspection intelligence.

Speakers:

Andrew Mitchell

Director Lifesciences Strategy and Product Marketing
Intralinks Ltd.

Andrew has many years of experience working in and with the Life Sciences industry, delivering innovative software solutions through his time with Covance, Relsys, Medidata and BioPharm Systems (Oracle Gold implementation partner). With a focus on Software as a Service, he has a strong belief in providing solutions that simplify and improve the user experience and the relevant subject matter expertise to ensure delivery of real benefits and enhanced compliance.

Cost: No cost!