eShowcase

June 1, 2004

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-06-01-2004,

Datatrak International's Phase IV, Espicom's World Pharmaceutical Markets, and Keris, Inc.'s Vital Consent

Datatrak Phase IV™

The postmarketing surveillance of Phase IV trials now has its own Datatrak software application

Datatrak International (Cleveland, OH) has added a new component to its suite of EDC programs, allowing for customized post-release clinical trials. Datatrak

Phase IV™ is a customized data collection platform designed just for postmarketing surveillance.

The program offers a "menu" of options, allowing sponsors to add as many levels of diligence to their trial as needed. For instance, a 20,000-person trial might not have as many necessary fields as a 2,000-person trial to keep a high level of significance. Datatrak only charges for the options a user selects, making price as well as scrutiny a matter of choice. Datatrak expects the number of Phase IV trials to increase as pharmaceutical firms look for increased market share for their existing drugs.

If evidence of another indication makes itself present by the time a Phase IV trial has begun, a new aspect of the study can begin. Since most software is not interchangeable regarding

Phase IV and regulatory fields, this can present a problem. Datatrak's Phase IV database, however, can be used to populate a regulatory Phase III database without having to restart the study just to regain existing data, or bring in a different product to handle Phase III.

World Pharmaceutical Markets™

Use this global data archive and reference to understand the countries hosting an upcoming clinical trial

Espicom (Princeton, NJ) offers a good example of the difference between information and data. Information is just numbers, i.e., the hospital services statistics or international trade of a country. Data is that same information, but put to good use to describe the country's health care system.

Espicom believes that the national picture of each country you're planning on doing business with is crucial to understand. Its World Pharmaceutical Markets™ service offers access to databases of 62 countries, from Argentina to Vietnam, and it is updated to reflect recent trends in health and economy. Other contents include profiles on industry markets, medical personnel, out-patient care, background and population, and health status. A new feature, five-year forecasts, shows estimates of what will be booming fields a few years from now. Each country also has a directory to contact offices of government, trade, and health care providers.

Clinical trials need to go where the CRFs are. Weighing the infrastructure, hospital services, and economy of competing countries can show advantages that wouldn't be otherwise apparent. WPM offers tools in making that key decision.

Vital Consent™

Details like 3D animation and quizzes makes Keris's informed consent program a sign of relief

Keris, Inc.'s (Bellevue, WA) Multimedia division is different in that a valid informed consent is the end of their quest, not the start. The company's Vital Consent™ is focused on getting subjects to sign on the bottom line, and more importantly to have them know what their John Hancock means.

Keris's presentations are available on a Web-connected computer screen, and include 3D animations, narration, and exam questions along with plain text to enrich the learning experience. Such a system ensures an identical presentation, and frees up valuable staff time. All materials are written at an eighth-grade level or below. Content is available in multiple languages, so people who prefer speaking Spanish (or other languages) can follow in their first tongues. With informed consent focused on the "informed," Keris believes both subject retention and adherence to protocols improve over the course of the trial.

The company also markets an electronic data capture suite, Vital Tracker™, and a clinical data management system, Vital Source™.

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