eShowcase

April 1, 2004

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-04-01-2004,

IntraLinks' IntraLinks, Pharsight Corp.'s Trial Simulator, and Thomson CenterWatch's Drugs in Clinical Trials Database and eDirectory of the Clinical Trials Industry

IntraLinks' Internet-driven electronic document system allows management solutions for all of a trial's forms

IntraLinks (New York, NY) offers a multifaceted database for a clinical trial staff with different uses for everyone from the sponsor on down to the CRA. More importantly, they also have experts on hand to guide each team member through whatever questions they have.

With IntraLinks, users have access to all the regulatory forms they'll need, all in convenient PDF format. Site contracts, budgets, 1572s, protocol documents-all included, all distributable to anyone in the process along with a reminder note to ensure they get filled out. Sending out a safety notification is as easy as forwarding an email. It's all done via the Internet, so any computer with a modem becomes a possible access point.

The software tracks which parties receive each document, and stores/archives completed versions of forms for audits. Adaptable permissions let each person who logs in see only the documents he or she needs. The 128-bit security feature ensures that no one who isn't supposed to be looking around will be. Running a report will let an investigator know exactly how much progress has been made. And if anyone isn't sure about how things work, a 24/7/365 tech support can offer guidance in over 140 languages.

A study simulator that predicts the unseen trial problems lets PIs fix their mistakes before they're made

Pharsight Corp. (Mountain View, CA) knows that much of the work in a successful clinical trial is done before the first site has gone into action. Simulating the action, like a practice game, lets the people in charge anticipate problems before the occur.

The company's Pharsight Trial Simulator lets a sponsor considering a trial create a virtual environment to have a "trial" clinical trial. In one PTS option, compare two series of doses to see which one, on which dosage schedule, would deliver more useful information about the drug's efficacy and safety. And with percentage results based on how clearly you've defined your goals, you can ensure that the multisite trial about to begin runs smoothly.

No one wants to realize halfway through a long expensive trial that they should have better formulated an assumption, or aren't collecting the correct amount of data points. The simulator gives sponsors and investigators a "trial" trial run of sorts, to practice design skills for the big show.

Pharsight's other products include PK Automation for pharmacokinetic data, Pharsight Knowledgebase Server for PK/pharmacodynamic data, and education via training and consultation.

Two new reference materials give the clinical trial world both a phone book and an encyclopedia of the industry

Thomson CenterWatch (Boston, MA) has created two databases which almost anyone involved in the clinical trial world could put to good use.

The first, Drugs in Clinical Trials Database, lists over 2000 drugs in over 800 different conditions, from asthma to zinc deficiency. The drugs are indexed by formulation, manufacturer, phase status, and more. The online reference is updated daily for new FDA approvals and trial announcements, so it's always fresh.

The second new database, eDirectory of the Clinical Trials Industry, is a massive list of over 1400 clinical trial professionals. Besides listing over 140 pharmaceutical and biotech companies, it includes over 170 CROs, over 30 IRBs, 800 sites, 80 SMOs, and over 200 consultants. It was previously only available as a printed document, but now is accessible on the Internet.

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