eShowcase

April 1, 2005

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-04-01-2005,

DigiScript (Franklin, TN) acts like a teacher's college of sorts for study investigators. Managers ensure their staff acts properly in every location, making each independent site unified in its approach to the clinical research at hand.

A multimedia Webinar program lets experts teach investigators across the country, or across the globe

DigiScript

(Franklin, TN) acts like a teacher's college of sorts for study investigators. Managers ensure their staff acts properly in every location, making each independent site unified in its approach to the clinical research at hand.

TrialTrainerPlus™

TrialTrainerPlus is a Web conferencing and on-demand learning program which allows rich media presentations to be shown at the viewer's convenience. Video files, PowerPoint slides, rolling transcripts and other text-based materials all can interact to reinforce important points.

Presentations can even be done live, and saved to be viewed by people unable to watch the real-time version. Much of the money saved is from unneeded hotel rooms and cross-country flights.

The idea is similar to electronic informed consent tools; if everyone hears and sees the exact same thing, they will be unified by their shared perspective on it. And that translates to multiple sites acting as a franchise, if only for this trial.

The company has offered online learning programs for everyone from the Department of Defense to GE and banking and accounting firms. It is used by 18 of the top 20 pharmaceutical companies.

DigiScript, (800) 770-9308, www.trialtrainerplus.com.

This mental diary to capture the moods of manic-depressive subjects has been 30 years in the making

The ChronoRecord Association

(Fullerton, CA) is a nonprofit organization working to increase the understanding of mood disorders.

ChronoRecord™

ChronoRecord is an electronic version of the ChronoSheet, developed in the '70s to help follow mood fluctuations of patients with manic-depressive illness. It was revolutionary then, and still not widely enough used now.

The mechanics of ChronoRecord are familiar to those with EDC experience. Patients or subjects using ChronoRecord fill out a daily form on their computer describing mood, sleep, medications taken, and life events. That information can either be emailed to the site or saved on a floppy disk. Or, nontechnical users can record the info in a paper diary and have it data-entered at the site.

Since ChronoRecord is a nonprofit, it only charges what it needs to cover manufacturing and distribution. Costs are no more than $150 per patient.

Back when ChronoSheet premiered, mood disorders were not clearly seen as treatable illnesses. Now that such disorders have had some of their stigma removed, it is important to have records of mood to go alongside other medical records for a proper data analysis.

ChronoRecord Association, (714) 773-0301, www.chronorecord.org.

There is now a way to determine how many subjects a site screens and enrolls before the trial is over

Praxis

(Brentwood, TN) created PraxisDirect as a program to let sponsors or sites monitor every step of a subject's recruitment in a clinical trial.

PraxisDirect™

The first step is the subject decision whether to be involved at all. Recruitment information of their initial prescreening responses goes into the system. The medical info of those who did not sign an informed consent will never be associated with the person.

After the subjects are qualified and enrolled, their metrics go into the same database that held the prescreening info. Fields include referral source, inquiry, and disqualifications at a screening visit.

Sponsors can also check out weekly activity reports, numbers of inquiries and respondents per site, and average enrollment times. An updated list of referrals ensures that no possible subject will fall through the cracks. This data is obviously much more useful to receive during a trial than after it is over.

PraxisDirect uses VeriSign Secure Site Pro, a Cisco firewall, and physical security to ensure that private information stays that way.

Praxis, (615) 312-8207, www.gopraxis.com.

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