Prepare the Ground Before Rolling Out EDC, P&G Advises

The key to successful conversion from paper clinical trial records to electronic data capture (EDC) is in the advance preparation, said a key figure at Procter & Gamble (P&G).

Building an infrastructure helps standardize information and processes and better coordinate the peripheral tasks that go along with rolling out EDC, said Megan Gassert, global training manager for P&G's EDC support services, at an industry conference sponsored by the Center for Business Intelligence in Philadelphia March 13. Those peripheral tasks include:

Assessing a site. Determine whether that assessment can be online or needs to be done in person; Provisioning, such as deciding whether to buy or rent system hardware; Setting up a help desk. Think about what you need it to provide, Gassert advised. In most cases, a help desk is equipped to offer basic navigation tools, including password resets, account Creating and implementing a training program. The help desk tracking system can be used to identify trends in questions and problems, and to signal any gaps or weaknesses in a training program. Plan on training sponsor users, monitors and site users, Gassert said; and Establishing a means to track users and sites. Among other benefits, this can help get the site up and running faster, and alleviate the need for end user training and redundant provisioning.

P&G launched its first EDC pilot project in 1999 and conducted its first EDC technology transfer in 2001. Today, the firm is using a mixture of internal and outsourced capabilities on its EDC projects, Gassert said. She added that P&G's internal EDC coordination group currently supports more than a dozen studies.

Whether outsourcing is necessary is a judgment call, based in part on being realistic and knowing what a company's internal infrastructure can handle. But outsourcing is not an "all or nothing" proposition, and should be focused on components or aspects that make sense from a business perspective. In any case, only work with vendors you have confidence in, Gassert stressed, adding, "work with, not against, your vendors."

Keeping track of vendors is critically important, Gassert noted. She advises developing a business requirement document that defines the handoff between tasks. This document should focus on help desk and secondary technical support, assessment and provisioning, training and help desk issues, and coordination between the project team and the EDC project.

P&G uses a central tracking database that includes data on all users, sites and sponsors for each study. This data includes "go live" and lock dates for reporting trial information retained across studies, as well as training information.

Embrace Remote Training

Training employees and other system users in different locations presents a special cost and efficiency challenge, Gassert said. P&G built its own web-based EDC training that tracks users in a database, provides global 24/7 access, and provides activation forms and training certificates.

Remote training has helped P&G save on travel costs as well as standardize its processes, which has reduced costs by cutting down on wasted time and missed deadlines, according to Gassert. The centralized and proactive help desk also receives an activity report that helps it quickly identify areas where training needs to be improved. -- Michael Causey