Another SOP is that sites lock up laptops every night, just as they would drugs or a CRF binder. As a result, Janssen has
reported only a one percent hardware-loss rate from either a broken or stolen laptop—and a zero percent data-loss rate across
both trials. A less obvious regulatory element is the 21 CFR Part 11 compliance of the software, which helps ensure data integrity via
time stamps and audit trails for all information gathered. The time-stamped data offers a side benefit, too: discouraging
log-keeping procrastination—the so-called "parking lot effect" of people filling out information in the parking lot prior
to an office visit. Satisfying users Because many of the sites that signed on were technology-na—for some it was their first clinical trial—a simple user-friendly
interface is crucial to successful eSourcing. Doctors and nurses using the software must be able to complete a CRF, for example,
with a minimal investment of time in formal training. Plus, automated functions such as data-validation checks needed to be
unobtrusive and not slow data entry. Key to this process is the translation of paper-based trial processes and information formats to electronic processes and
formats. For example, when initiating a clinical study, electronic CRFs (eCRFs) can be created as flexibly as if they were
created on paper. When viewed on-screen, the eCRF appears as it would on paper. To complement ease-of-use, training is critical to guide users to ask the right questions and properly design the Web-based
pages for collecting the necessary patient information. The protocol-design process overall is similar to a paper-based trial,
but with the key advantage of speed afforded by the electronic medium. Because user satisfaction with the technology would determine long-term success, Janssen surveyed its physicians to evaluate
their experience. A strong majority of the doctors indicated they would rather not return to paper-based trials. The ROI The cost per page of data gathered during trials has decreased for Janssen, but greater ROI has emerged around data quality
and data accessibility. The eSource model has dramatically changed the way Janssen's trial monitors work. Rather than travel to numerous sites nationally
or globally conducting protocol-compliance checks, monitors now examine the data being collected and fully manage trial processes
from their home or office via a secure Web portal. They can, for example, query sites and generate data-correction forms with
near-real-time speed. Monitors still usually visit investigator sites to initiate or end a trial, but their travel costs have
been reduced significantly. Also, fewer queries and data corrections need to be issued from monitors because automated edit-checking functions in the
investigator's software intercept data-entry errors before they are logged. On-the-fly cleaning of data, which is immediately
indexed and fully searchable, is estimated to permit Janssen to close its database two to four weeks earlier than previously
possible with paper-based trials. A faster database lock will enable Janssen to submit a new drug application (NDA) for FDA approval faster, or publish a Phase
IV trial follow-up study sooner. This time saved is money saved—potentially millions of dollars in opportunity costs. Spreading eSource Janssen initially considered building its own eSource software, but recognized that conducting clinical trials was not its
core competency. Marrying the technology and the clinical experience would be difficult. Moreover, such in-house development would require large investments in support infrastructure and services. The industry adage
is that efficient and effective EDC is 30 percent technology and 70 percent process. It was more economical and practical
to engage Medidata to host the system in its own data center and provide help-desk support to users and continue to invest
in future functionality. Janssen collaborated on the development of Medidata Rave Remote and provided requirements that ensured the software met all
of Janssen's parameters and were fully field-tested. The two companies have agreed to make the software available to other
pharmaceutical firms that wish to leverage the advantages of eSourcing. Louis Pozzo is manager of clinical trials and relationship management with Janssen Pharmaceutica, 1125 Trenton-Harbourton Road, Titusville,
NJ 08560, (609) 730-2000, fax (609) 730-2323, http://www.janssen.com/.
Glen de Vries is chief technology officer with Medidata Solutions, Inc., 79 Fifth Ave., 8th floor, New York, NY 10003, (212) 918-1800,
fax (212) 918-1818, http://www.medidatasolutions.com/.
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