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Integrium Introduces Its Integrium Clinical Excellence (ICE) Methodology to Assure Consistent Delivery of Sponsor Clinical Trials
Date:5/5/2008

TUSTIN, Calif., May 5 /PRNewswire/ -- Integrium, LLC(R), a cardiovascular and metabolic focused clinical research organization with a long history for delivering reliable results, has officially launched Integrium Clinical Excellence (ICE), a metric and performance-driven process designed to consistently deliver actionable results on time and on budget in all of its current and future clinical trial programs. ICE is a series of steps that provide a high level of transparency to Integrium sponsors to allow them to make confident, informed decisions for their clinical trials by minimizing risk factors and maximizing the timely implementation of contingencies to ensure success.

"After listening to our sponsors, we realized we can provide more value by further standardizing our processes and especially our feedback mechanisms," said Eileen McAuley, Chief Operating Officer at Integrium. "We continually strive to improve our methods, assess metrics and set higher standards for our project leaders to ensure success of our sponsors' development programs."

The standardized processes comprising ICE, feature four integrated steps that logically guide the sponsor through their clinical trial. Integrium has built new tools and metrics to track and measure the process via the ICE Project Scorecard. The four steps are:

o ICE Advance - To effectively support the Advance phase of any clinical

trial, Integrium brings years of clinical experience, the widely

accepted clinical knowledge of our medical staff and company founders,

and therapeutic foresight to evaluate each sponsor's specific study and

program plans before being awarded the trial. Integrium makes effective

use of its clinical site and Investigator databases, to provide a high

degree of predictability to site performances and commitments to

planned enrollment rates.

o ICE Alliance - A targeted Kick-off Meeting, attended by everyone from

the sponsor team and all Integrium project team leaders, is scheduled

two weeks after the Advance phase is initiated. A Project Alliance

Meeting is then conducted with the primary objective to align the

Integrium team to sponsor expectations and to outline Integrium's

approach for the conduct of the trial. Use of the ICE Project Scorecard

provides for excellent tracking of important clinical milestones and

agreed-upon objectives throughout the conduct of the trial.

o ICE Action - Following the Project Alliance Meeting, the assigned

project team expertly executes the site and patient recruitment,

patient monitoring, data capture and cleaning plans agreed upon by all

team members.

o ICE Apex - The Apex phase represents the pinnacle of ICE objectives,

occurring upon the completion of contracted services. A lessons learned

document is completed and updated to address the systematic performance

of Integrium processes and ensure timely and accurate delivery of final

documents.

"Integrium Clinical Excellence is more than just adding names to the steps of a trial. For us, it is the way we do business and ensure success for our sponsors," added McAuley. "For more than a decade, we have been providing therapeutically-focused clinical services. Now we have standardized processes and systems in place to ensure our therapeutic expertise is applied with a view across all aspects of clinical operations."

To support the ICE launch, Pierre Devesly joins Integrium as Executive Director, Clinical Operations, with responsibility for the continual development of metrics and benchmarks, as well as provide overall leadership to all project teams. Functional areas reporting to Mr. Devesly will be Project Management, Field Operations, Data Management, Biostatistics, and Medical Writing. Before joining Integrium, Mr. Devesly served in senior executive positions in project management and clinical development with Kendle, Quintiles, Eisai, Forest Laboratories and Organon. Mr. Devesly will be responsible for implementing Integrium's Center for Clinical Excellence, by continuously benchmarking processes via lessons learned, ensuring accurate and timely deliverables, and establishing training and certification programs for every position within Clinical Operations. Integrium's high-performing teams are continually trained on the latest tools, technology and metrics available to optimize our sponsors' trials.

Liza Moore is promoted to Director, Field Clinical Operations, with major responsibility for providing leadership and support for the development and training of Integrium's Clinical Research Associate (CRA) regional teams. Ms. Moore has extensive senior project management and field operations management experience with Integrium and brings a wealth of clinical research experience working with both CROs and pharmaceutical companies.

"I am excited to have Pierre and Liza, both highly experienced professionals in clinical research, join Integrium's Clinical Operations management team. These changes will be extremely beneficial in continuing to establish Integrium as a global industry leader in the conduct of clinical trials," said Ms. McAuley.

"Providing our sponsors the most qualified professionals to ensure the successful completion of their clinical development programs is our driving force. Therapeutic expertise combined with a complete understanding of the drug development process from the CRO and the sponsor's view is critical to ensuring our sponsors a successful clinical trial. The initiation of the Integrium Clinical Excellence process will be a key factor to our evolving success," said Joel Neutel, MD, co-founder and Director of Research at Integrium.

About Integrium, LLC(R)

Integrium is a cardiovascular and metabolic focused clinical research organization with an unrivaled reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical, biotechnology and medical device companies look to Integrium for a complete range of customized Phase I -- Phase IV programs in cardiovascular and metabolic therapeutic areas. Combining the Integrium Clinical Excellence (ICE) methodology and therapeutic expertise leads sponsors to more confident, better-informed drug and device development decisions. Integrium is headquartered in Tustin, California, with operational offices in Bedminster, New Jersey and Johannesburg, South Africa. For more information please visit integrium.com.

Integrium is a trademark of Integrium, LLC.

(C) Copyright 2008 Integrium, LLC. All rights reserved.


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SOURCE Integrium, LLC
Copyright©2008 PR Newswire.
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