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August 1, 2005

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-08-01-2005, Volume 0, Issue 0

Tools for Clinical Trials Professionals

Handle a myriad of marketing authorization tasks with Synapse's RegTracker v4

Synapse's

(Cheshire, UK) marketing authorization management tool, RegTracker v4, is designed to help streamline and enhance the process and bring products to market faster. The more product variants and markets that are involved, the more complex the process becomes. The software provides a central repository for all of the information, processes, and paperwork associated with marketing authorizations.

RegTracker v4™

RegTracker v4 fully integrates with existing electronic document and content management and submission systems. It provides a central repository of all relevant information that can be accessed and manipulated by key personnel. Since it is Web-enabled, the data is sharable between departments, no matter where they are.

RegTracker v4 helps manage approvals, change projects, and identify bottlenecks as you comply with regulations. It supports European Centralized, Mutual Recognition, and Decentralized procedures, plus it automatically generates content for SPL, PIM, and EVMPD needs. RegTracker v4 is also 21 CRF Part 11 compliant and allows rapid impact analysis for alerts and withdrawals.

The Synapse Partnership Limited, +44 (0) 161 929 5777, www.regtracker.com..

Master the dance of managing a drug pipeline with Livelink enterprise content management

Open Text's

(Chicago, IL) enterprise content management systems are used for energy grids, architecture, and finance. But as anyone in the drug field knows, the drug pipeline sometimes seems the most complex system of all.

Livelink™

Open Text has designed three of its Livelink products especially for the clinical trial world. Livelink for Clinicals can capture and review all of the information produced by a trial. It works with both electronic and paper formats, since no one seems to have completed the all-E switch, but everyone has at least started. Open Text can support many leading EDC and scanning products.

Livelink for Collaborative Submissions is built to support that crucial moment when you hand in your work. Everything you need to do regarding submissions can be done with this program. It's scalable to fit your project and offers process automation tolls for everyone, so everyone is on the same page.

Livelink for Regulated Documents lets users manage each step of a regulatory document's journey, from requesting a change to review to approval and deployment to archiving. And you'll stay compliant with protocols like 21 CFR 11 the whole time.

Open Text, (800) 499-6544, www.opentext.com..

Exco InTouch knows why most patients become noncompliant: they simply forget

Exco InTouch

(Hertfordshire, UK) poses what seems like a trick question on its Web site. What's the most important part of a trial? The CRF? Drug? Site?

Exco InTouch

Nope, it's the patient. Often patients become noncompliant due to simple forgetfulness. That's why Exco InTouch offers an astoundingly simple concept: remind the patients to take their meds.

Their SMS (Short Messaging Service) sends out text messages to patients of a clinical trial. "Have you taken your medicine today? Yes or No." The message serves two crucial purposes: it gives patients a daily reminder to stay compliant, and it creates an online patient diary of compliance.

Patients choose what time of day to receive the message, and they can choose between a text-messaging-enabled phone or a computer with an Internet connection. Billions of these messages are sent every year: just one of them a day could ensure statistical significance in an upcoming clinical trial.

Exco Group also provides outsourcing and recruitment services through Exco Pharma and Exco Consulting.

Exco Group, +44 (0)1279 658600 www.excointouch.com.

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