How to Improve Sponsor and Site Collaboration

February 24, 2015

  • eTMF Resources

This is a guest post authored by Andrew Mitchell, Director: Life Sciences Strategy and Product Marketing at Intralinks.

Today, much of the site-based documentation is paper-based. Using solely paper-based solutions may present significant cost and risk consequences to the clinical trial process. For instance, the cost of sending a monitor to a site averages about $5,000 just for one day, and almost all of the monitor’s time is spent reviewing paper documents. And when it comes to risk, paper-based documentation presents a lack of visibility into site performance, in addition to audit risk and manual reconciliation of TMF and site records challenges.

To be effective and efficient, sponsors need to close the gap among relevant parties in a clinical trial with an effective electronic documentation solution that can easily streamline communication and workflow. Solutions such as eTMF and eISF help support the industry’s needs of managing site documentation, remote monitoring, overseeing control for the investigator, and improving monitor site visits – making certain that relevant documents are available for inspection at any point. These solutions should be able to integrate with your sites’ workflows for maximum efficiency. They should also allow an option for providing automated distributing and updating of documents to ensure that all site documents are up-to-date, in the right folders and inspection ready – while still allowing each party to have complete control over their own information.

To show you how to replace manual paper-based procedures and successfully and compliantly implement secure offsite document access and management, Kathie Clark, Wingspan Technology’s Vice President of Product Management, and myself, will co-host a complimentary Business Review Webinars live presentation on Wednesday, March 4, at 4:00 PM London / 11:00 AM New York.

The “Closing the Loop: eTMF and eISF reduce paper and support remote monitoring” webinar will help you understand the regulatory requirements about the separation of TMF and ISF as well as how an integrated solution can increase efficiency. Additionally, you’ll gain best practices around how automation can be implemented to share documents from eTMF to eISF, and how sponsors and sites benefit from increased visibility.

To join the webinar, please register by clicking here. We hope you can make it!

“Meet Our Guest Blogger” Andrew Mitchell, Director: Life Sciences Strategy and Product Marketing

Andrew Mitchell
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.