May 7, 2013 | EMC announced new solutions at its EMC World event leveraging the EMC Documentum platform to meet compliance requirements, increase productivity and securely collaborate across the extended enterprise while accelerating time to value and reducing the total cost of ownership.

“We had shifted our focus a little bit away from the Life Sciences industry,” said Lori McKellar, Director, global market development, life sciences, told eCliniqua, “and last year we re-dialed back in, and we enhanced our solutions portfolio and really updated it in a significant and dramatic way.”

The life sciences industry has changed so much recently with new technologies, McKellar says.  

Last fall, EMC released a clinical trials application for eTMF (electronic trial master file)—the start of a series of applications— EMC Documentum for Life Sciences—all built on the Documentum enterprise content management platform and the D2 client, a client that allows users to configure, not code, new applications. 

The solution suite harnesses an information architecture based on the Drug Information Association (DIA) Electronic Document Management (EDM) and Trial Master File (TMF) Reference Models, and is fully integrated to simplify submissions and other critical business processes, and maximize productivity and ensure easy access to information with configurable, intuitive, and personalized interfaces. 

Steve Scribner, EMC’s principle consultant in the life sciences, sits on the DIA steering committee for reference models. “I’ve been involved since their inception in 2006—and all the efforts in between. We stay very close to those [efforts]. As we anticipate new models coming—and there are extensions that are coming—then [EMC] will pull them in and analyze those extensions and figure out ways to upgrade and enhance the model at the foundation of all of these life science applications,” Scribner said. 

Later in the year, McKellar said, EMC will release the regulatory and research applications. 

Our goal is to invest in the life sciences industry in the long term, and figure out what are the right solutions that will solve the biggest challenges that our organizations are seeing,” she said. 

The clinical trial solution uses the latest version of the Documentum D2 client (v 4.1) to offer advanced usability, McKellar says. It allows users to use widgets and really customize their user interface. The client also supports Google widgets, so users can pull in feeds from various websites or news sources. “It’s a lot of personalization,” 

McKellar said. “We also offer integration with mobile devices.” 

The application can be deployed on site or in a cloud environment. “Whatever the user is most comfortable with,” McKellar said. 

Users can build clinical trial templates to standardize their operations, and make use of conditional terms so that workflows are set up intelligently based on the conditions of the trial. Document counters ensure regulatory compliance. The system supports inspector access for agency review or audit. 

An integration with Microsoft office streamlines the review process, allowing reviewers to leave feedback and track changes.