By Ann Neuer 

April 8, 2015 | Keeping certain documents under the control of the investigator is a basic tenet of clinical trials and built in to the new collaboration between Intralinks and Wingspan Technology. The purpose of the collaboration is to develop an integration between the Intralinks’ electronic investigator site file (eISF) and Wingspan’s electronic trial master file (eTMF). The eISF solution provides sites with a simple, secure way to file site-based documents in the cloud. Wingspan’s eTMF, also cloud-based, ensures that the TMF contains the correct version of essential documents and facilitates management of trial conduct and inspection-readiness.

The yet-to-be-deployed integration will improve document flow by allowing sponsors who adopt the eTMF to automatically push eTMF content out to all their sites with eISFs. In addition, the integrated system will automatically request documents from sites as milestone dates approach and eliminate the need for wet ink signatures. These efficiencies will improve study quality by reducing the document-related issues so often identified during site inspections by health authorities. Also, they will help cut the number of costly on-site monitoring visits, a key benefit as the industry edges toward greater use of risk-based monitoring.

To illustrate the value of the eISF, Andrew Mitchell, Director of Product Strategy & Marketing (Life Sciences), explains, “We make it simple for sites to file and manage their content in the cloud across multiple studies and sponsors instead of the current situation of systems for each sponsor and types of content. There’s often one place for filing essential documents, another for source documents, another for contracts and budget, medical images, and so on. Sites may need to use 15 systems for just one sponsor’s study, each with auto-expiring passwords. We need to reduce the site’s administrative burden so they can focus on actually running the trial.”

According to Mitchell, what is so different about the eISF is that documents do not need to stay in the Intralinks system for them to be controlled. If a monitor downloads a spreadsheet containing patient identifiable information, he or she can copy it onto other devices, but the site still controls access as the monitor cannot print it or share it with others. “We do this without requiring installation of any plug-ins, and it’s a seamless process,” says Mitchell.

With the integration, joint customers will go one step further. They will be able to cut out manual steps when compiling and reconciling clinical trial documentation. One example is what happens with the Statement of Investigator Form 1572. Traditionally, when the investigator completes the 1572, it is printed, signed, and scanned, and that copy is then sent by e-mail or manually uploaded to the eTMF. These actions may lack an audit trail, may not be secure, and could possibly result in the 1572 being associated with the wrong study. With the integrated solution, however, the form is signed electronically and flows seamlessly from the eISF into the eTMF, a big timesaver. There is no need to reconcile and archive a paper original because there isn’t one.

Kathie Clark, Vice President Product Management for Wingspan, comments on the manual steps that will be eliminated with the integration, particularly related to reconciliation of documents. “The monitor has to make sure that the site has the same documents and the same versions as the sponsor, but with the integration, the reconciliation step will be greatly reduced because both sponsor and site will be using the same version,” she explains.

The value is in better document quality and reducing workload, and as Clark points out, “The CRA can concentrate on what we want them to be doing, not dealing with paper, pulling information out of e-mails or scanning site documents. Instead, they can focus on risk-based activities and coaching and educating the site.”

Currently, the integration is a work in progress. Clark says the industry is just starting to see this solution. “We just did our first public demo, and another one is scheduled for May.”