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February 1, 2005

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-02-01-2005,

A new database design is behind a way of generating reports when you want them--such as right now

A new database design is behind a way of generating reports when you want them—such as right now

Incisix

(San Diego, CA) knows that most people want their data now, if not sooner. Its updated TrialsReporter software allows for all information from a trial to be downloaded and crunched within moments, for up-to-the-minute relevance.

Tools for Clinical Trials Professionals

TrialsReporter runs on the DataFlexer database, which does not arrange itself in the standard row-and-column format of most databases. Instead, it allows itself to be modeled into just about any configuration a customer wants. It also creates speedier, more natural searches. That gives it an advantage, Incisix says, in creating custom reports with greater flexibility.

The reports can be made from any study variable, from a demographic to an adverse event to location. Running constant reports on the data as it comes in can help determine flaws in the studies. Multiple users can generate reports simultaneously. Incisix even claims to help you "fail faster"—better to cut bait now than after two years of expenses and hope.

TrialsReporter 1.2™

The password-protected program is available online, and set-up of the system should only take an hour or so. Incisix's databases are also used in tandem with J2EE, SOAP, and LDAP database technologies.

Incisix, (858) 860-0630, www.incisix.com.

Reduce or even eliminate adverse drug reactions before your trial even starts with SafeBase

TheraSTrat's

(Allschwil, Switzerland) SafeBase Knowledge Base is designed to hopefully make all the adverse event reporting software programs dusty from lack of use.

SafeBase is a vast collection of adverse drug reaction data, detailing the known pharmacogenomic and pharmacogenetic, toxicogenetic and toxicogenomic, and chemogenomic knowledge of tested treatments. Users of the database are able to remove at-risk subjects from their trials before they begin taking any experimental treatment. This could save the trial its statistical significance.

Version 2.5 includes such features as a sequence manager, knowledge base searches, graph assistants, node context searches, parallel neighbor searches, deep neighbor searches, and more. SafeBase even has detailed information on drugs which have been removed from the market due to adverse events.

SafeBase 2.5™

Adverse drug reactions are, unfortunately, a leading cause of death in the real world. No amount of research will be able to completely remove risk from the process of clinical trials. SafeBase is a solution that significantly reduces the risk to both the sponsor and the subjects.

TheraSTrat, (41) 61 485 5010, www.therastrat.com.

One company is giving hope to cancer drugs that never made it out of the clinical development stage

Genetics Squared

(Ann Arbor, MI) may be one of the few biotech companies who will step forward with interest at a time when most every other company is stepping back.

Genetics Squared's focus is on clinical cancer therapeutics. Its business plan is to "rescue" promising but struggling compounds from clinical and market failure. Not every drug makes it through the pipeline, so sponsors start focusing on others that are still in the running.

Evolutionary drug development

The picking of the wheat from the chaff of failed drugs is accomplished by Genetics Squared's evolutionary drug development technology. The idea is to use the existing data from the first trial, figure out the ideal patient population for the treatment, then go back for a second round of clinical development. If only one new cancer drug is discovered this way, it will have been worthwhile.

The company's newly formed scientific advisory board includes consultant David Fry, PhD, i3 Statprobe director Philip L.C. Banks, MS, and chair Richard Cote, MD, of the University of Southern California's Keck School of Medicine.

Genetics Squared, (734) 929-9475, www.genetics2.com

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