Proven leadership in cardiovascular, metabolic disease and dermatology trials





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MEDIA INQUIRIES

Media inquiries about Integrium Clinical Research or its services should be directed to:

             Randy Wambold                              Juli Greenwood
Tel +1 (781) 672-3119 Tel +1 (781) 672-3137
rwambold@chenpr.com jgreenwood@chenpr.com

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APPLIED CLINICAL TRIALS: INTEGRIUM LAUNCHES DERMATOLOGY PRACTICE

July 14, 2010 – Early last month, Integrium launched its expansion into the dermatology therapeutic area. Dr. Mary Spellman, dermatology drug development expert, will lead Integrium’s Dermatology Clinical Research Group.

The company’s new Dermatology Clinical Research Group will help its clients design studies, leverage its relationships with investigators to help identify and recruit study patients, and effectively manage their studies.

“Selecting the right CRO partner is critical to our success,” said Dr. Sharon Levy, Senior Vice President of Product Development for Graceway Pharmaceuticals, a firm focused on developing branded prescription products for the dermatology and women’s health therapeutic areas. “We selected Integrium not only for their scientific and clinical trial expertise, but for their experience in studies of topical therapies. They have helped us complete enrollment and lock the study database ahead of schedule for a multi-center Phase 2 trial.”

Dr. Spellman is a board-certified dermatologist with 20 years of experience in clinical research and drug and medical device development. Dr. Spellman has helped to achieve US FDA and ex-US approvals for multiple topical, systemic, and biological drugs, as well as dermatological devices and vaccines, and has served as a medical and safety officer, and nonclinical and clinical development and regulatory strategist to biopharmaceutical and device companies. In addition to working with Integrium, Dr. Spellman maintains a pharmaceutical and medical device consulting practice.

Before Integrium, Dr. Spellman served as Chief Medical Officer at Revance Therapeutics, where she was responsible for the development of novel topical therapies for aesthetic and medical dermatology indications. Before that she held senior roles at Biogen Idec, Inc., Connetics Corporation (now Stiefel Laboratories, Inc., a GlaxoSmithKline company) and Novartis Pharmaceuticals. Before entering the biopharmaceutical industry, Dr. Spellman was an Assistant Professor of Medicine (Dermatology) and Director of Dermatology Clinical Research at the University of California, San Diego School of Medicine and Medical Center, and an attending physician at the Veterans Affairs Medical Center in San Diego. After earning her medical degree from the Medical College of Wisconsin, she completed an internship in Internal Medicine Residency at Northwestern University McGaw Medical Center and a Dermatology Residency at the Medical College of Wisconsin Affiliated Hospitals. She is a member of the Board of Directors of the Women’s Dermatologic Society and the Editorial Board of the Journal of the American Academy of Dermatology.

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INTEGRIUM LAUNCHES DERMATOLOGY PRACTICE,
APPOINTS INDUSTRY EXPERT DR. MARY SPELLMAN TO HEAD GROUP

Leading Specialized CRO Expands Focus to Help Pharmaceutical Companies Navigate the Challenges
Inherent in Dermatology Clinical Trials and Speed Drug Development

Tustin, Calif. – June 8, 2010 – Integrium LLC, a contract research organization (CRO) specializing in cardiovascular and metabolic disease clinical research, today announced its expansion into the dermatology therapeutic area. Dr. Mary Spellman, dermatology drug development expert, will lead Integrium’s dedicated Dermatology Clinical Research Group.

Patient demand for medical and aesthetic dermatologic health care is on the rise, thanks in large part to aging baby boomers and an increasing number of available, cost-effective solutions. According to IMS Health, global therapeutic dermatology is an $18 billion market and growing – and identifying key trends and addressing needs unique to dermatologic drug therapy development is critical for pharmaceutical companies to keep up with demand.

Integrium has differentiated itself by demonstrating a deep understanding of the complexities and nuances of clinical research in the dermatology area, and by delivering successful clinical study solutions to biopharmaceutical companies. The company’s new Dermatology Clinical Research Group will help its clients design scientifically rigorous, yet feasible studies, leverage its relationships with reliable, high-quality investigators to help identify and recruit study patients, and effectively manage their studies from start to finish.

“We founded Integrium believing that a world-class team with experience levels far above industry norms would set us apart,” said David Smith, M.D., Founding Partner and Chief Medical Officer, Integrium. “Dr. Spellman’s appointment is very much in keeping with this approach. Our clients will benefit tremendously from her dermatology expertise and many years of drug development experience.”

“Selecting the right CRO partner is critical to our success,” said Dr. Sharon Levy, Senior Vice President of Product Development for Graceway Pharmaceuticals, a firm focused on developing branded prescription products for the dermatology and women’s health therapeutic areas. “We selected Integrium not only for their scientific and clinical trial expertise, but for their experience in studies of topical therapies. They have helped us complete enrollment and lock the study database ahead of schedule for a multi-center Phase 2 trial.”

“I’m pleased to be leading Integrium’s new dermatology clinical research group,” said Dr. Spellman. “Integrium has earned a strong reputation for its expertise in cardiovascular and metabolic disease clinical trials – and we look forward to carrying that same level of excellence to ensure our clients focused on dermatology studies are getting the support they need to bring better, safer therapies to market.”

Dr. Spellman is a board-certified dermatologist with 20 years of experience in clinical research and drug and medical device development. Dr. Spellman has been instrumental in achieving US FDA and ex-US approvals for multiple topical, systemic, and biological drugs, as well as dermatological devices and vaccines, and has served as a medical and safety officer, and nonclinical and clinical development and regulatory strategist to biopharmaceutical and device companies. In addition to working with Integrium, Dr. Spellman maintains a pharmaceutical and medical device consulting practice.

Before Integrium, Dr. Spellman served as Chief Medical Officer at Revance Therapeutics, where she was responsible for the development of novel topical therapies for aesthetic and medical dermatology indications. Before that she held senior roles at Biogen Idec, Inc., Connetics Corporation (now Stiefel Laboratories, Inc., a GlaxoSmithKline company) and Novartis Pharmaceuticals. Before entering the biopharmaceutical industry, Dr. Spellman was an Assistant Professor of Medicine (Dermatology) and Director of Dermatology Clinical Research at the University of California, San Diego School of Medicine and Medical Center, and an attending physician at the Veterans Affairs Medical Center in San Diego. After earning her medical degree from the Medical College of Wisconsin, she completed an internship in Internal Medicine Residency at Northwestern University McGaw Medical Center and a Dermatology Residency at the Medical College of Wisconsin Affiliated Hospitals. She is a member of the Board of Directors of the Women’s Dermatologic Society and the Editorial Board of the Journal of the American Academy of Dermatology.

Integrium will be exhibiting at DIA booth #228. Members of the media interested in speaking with Integrium should contact Juli Greenwood at 781-672-3137 or jgreenwood@chenpr.com.

About Integrium, LLC
Integrium is a therapeutically-focused, full-service contract research organization that specializes in dermatology, cardiovascular and metabolic clinical research. It has a strong reputation for delivering high-quality management of global clinical development programs and service to its clients. Combining the Integrium Clinical Excellence (ICE) study start-up and management methodology, and therapeutic expertise leads sponsors to more confident, better-informed drug and device development decisions. For more information please visit www.integrium.com.

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INTEGRIUM'S ENROLLMENT SKILL DRIVES NEED FOR REAL-TIME TRACKING

April 13 2010 - As reported last week, full-service CRO Integrium, a specialist in running trials for dermatology, cardiovascular and metabolic disease treatments, has signed with Phase Forward for the latter's Interactive Response Technology (IRT) trial planning and management solution. Integrium became a Phase Forward customer about a year ago, when it implemented the InForm EDC solution.

The Tustin, CA-based CRO is known for quicker-than-predicted trial enrollment, says COO Eileen McAuley via email. "We have had great success in the enrollment aspect of our trials and in fact this success has created the need for better tools to let us monitor enrollment in real-time."

Phase Forward's IRT solution, she says, will contribute to automating the enrollment-tracking aspect of Integrium's clinical research services. Some trials in the past, she says, involved no interactive voice response or Internet-based tools and required manual management of enrollment status. The CRO will roll out IRT in its newly launched dermatology service as well as its traditional cardiovascular and metabolic services. The goal is efficiency at the site level for both enrollment tracking and supply management, she says.

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INTEGRIUM SELECTS PHASE FORWARD IRT FOR ENHANCED CLINICAL TRIAL
SUPPLY MANAGEMENT

Specialized CRO Selects Phase Forward’s Interactive Response Technology Solution
to Help Ensure Optimal Supply Availability

WALTHAM, Mass. – April 6, 2010 – Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced that Integrium LLC, a contract research organization (CRO) specializing in dermatology, cardiovascular and metabolic disease clinical research, recently signed an agreement for the use of Phase Forward™ IRT.

Integrium works with specialty, development-stage, mid-size, and large biopharmaceutical and medical device companies, providing a complete range of clinical trial management services for Phase I through Phase IV dermatology, cardiovascular and metabolic disease studies. Integrium is headquartered in Tustin, Calif., with operational offices in Bedminster, N.J. and Johannesburg, South Africa.

The Integrium team implemented Phase Forward IRT because of its cutting-edge technology, rapid deployment and streamlined workflow to support advanced clinical trial planning and management, according to Integrium. Total cost of ownership was also a key consideration.

“A strong technology strategy is critical to overall success and cost efficiency in clinical drug and device development,” said Eileen McAuley, Chief Operating Officer, Integrium LLC. “We implemented Phase Forward IRT because we were impressed by the capabilities of the technology, Phase Forward’s reputation as a market leader, and the potential to adopt additional products within the company’s suite as our needs evolve over time.”

“Integrium has developed a strong reputation for expertise and excellence in dermatology, cardiovascular and metabolic disease clinical trials,” said Scott Dixon, Vice President, Global CRO Partnerships, Phase Forward. “We look forward to working with the Integrium team to help deliver the consistent, high-quality results that sponsors count on from the company.”

Phase Forward’s CRO partnership strategy is designed to assist CRO clients in achieving success in both the short and long term. Its customized structure and flexible pricing options help CROs of all sizes to invest in their own capabilities and capitalize on new growth opportunities.

About Integrium, LLC
Integrium is a therapeutically-focused, full-service contract research organization that specializes in dermatology, cardiovascular and metabolic clinical research. It has a strong reputation for delivering high-quality management of global clinical development programs and service to its clients. Combining the Integrium Clinical Excellence (ICE) methodology and therapeutic expertise leads sponsors to more confident, better-informed drug and device development decisions. For more information please visit www.integrium.com.

About Phase Forward
Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. Phase Forward’s products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants at over 300 organizations and regulatory agencies worldwide including: AstraZeneca, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, the U.S. Food and Drug Administration, GlaxoSmithKline, Harvard Clinical Research Institute, Merck Serono, Novartis, Novo Nordisk, PAREXEL International, Procter & Gamble, Quintiles, sanofi-aventis, Schering-Plough Research Institute, Servier, SGS, Tibotec and the U.K. Medicines and Healthcare Products Regulatory Agency. Additional information about Phase Forward is available at www.phaseforward.com.

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ERT (ERESEARCHTECHNOLOGY, INC.) AND INTEGRIUM, LLC FORM ALLIANCE
TO DELIVER INTEGRATED CARDIAC SAFETY AND AMBULATORY
BLOOD PRESSURE MONITORING SERVICES

PHILADELPHIA, January 30, 2009 -- eResearchTechnology, Inc. (ERT), (NASDAQ: ERES - News), and Integrium, LLC announced today their alliance to provide integrated Cardiac Safety and Ambulatory Blood Pressure Monitoring centralized core laboratory services to clinical trial sponsors and managers worldwide.

eResearchTechnology is a leading provider of centralized electrocardiographic (ECG), eClinical technology, ePRO, and other services to the biopharmaceutical , medical device, and related industries. Integrium is a cardiovascular, metabolic disease and dermatology focused clinical research organization (CRO) offering a full range of clinical development services, including Ambulatory Blood Pressure Monitoring (ABPM) centralized core laboratory services.

Under the agreement, ERT and Integrium will deliver a combined solution to meet the increased demand for centralized cardiac safety and ABPM services during clinical trials. The partnership will offer integrated services from project planning and set-up through study conduct, management, and data delivery for primary and secondary Cardiac clinical trial endpoints.

Integrium will provide a full range of ABPM supporting services to include robust & reliable equipment, proprietary analysis software, global on-demand 24/7 attended call center and scientific leadership. ERT will perform digital collection, measurement, interpretation, review, and distribution of cardiac safety data through its EXPERT 2.0 workflow-enabled data management system.

"This alliance addresses a growing need in clinical research to offer comprehensive, best in class services in these two closely related areas of clinical study," said Michael McKelvey, President and CEO of ERT. "While many sponsors recognize and source each company for its respective area of expertise, customers increasingly seek consolidation and streamlining in all phases of a clinical trial. ERT and Integrium approach the market in the same way -- focusing on scientific excellence, providing a quality product, and client satisfaction. We are both metrics driven and process oriented to ensure on-time, on-budget, reliable data delivery on a global scale."

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Integrium is a trademark of Integrium, LLC.