Dedicated Business Unit Responds to Unmet Need
BASKING RIDGE, NJ – August 16, 2004 – i3 has announced the introduction of i3 Drug Safety, a new business unit created to respond to the industry need for greater vigilance regarding the safety of drugs. i3 Drug Safety unites all of the i3 organization's renowned epidemiology and drug safety resources into one unit to enhance the delivery of safety services to the industry. Clients will benefit from a cohesive approach to support decision-making across the pharmaceutical lifecycle.
"We believe that assessing drug safety is a critical long-term issue, and we have the deep expertise to help our customers address it," said Donato Tramuto, i3 CEO. "We are responding in the i3 way -by creating a specialized, dedicated business unit, and putting our resources behind it to build on our already-strong foundation."
Led by Terri Madison, Ph. D, MPH, an epidemiologist from sister business i3 Statprobe, i3 Drug Safety includes a staff of drug safety coordinators -nurses, medical doctors and doctors of pharmacy-as well as respected pharmacoepidemiologists. Alec Walker, MD, Dr.PH, will continue as senior vice president of epidemiology. These experts will support a full spectrum of safety services, including pre-market clinical trials, safety surveillance studies, and pharmacovigilance activities. i3 Aperio, the drug experience registry launched in April to help researchers identify potential safety signals in new drugs faster, also will reside in i3 Drug Safety, under the direction of Arnold Chan, MD, ScD.
"This business will help improve drug safety throughout the development and commercialization lifecycle," said Dr. Madison. "Over the last several years, the industry has recognized the value of epidemiology as a crucial internal discipline to monitor and assess the safety of its products. Our epidemiologists have been conducting important pharmacoepidemiology work for more than 25 years, and are renowned for their deep experience in this area."
i3 Magnifi, which formerly housed epidemiology, now is focused on health economics and outcomes. This business unit uses its proprietary health care claims and laboratory results database on information from more than 11 million consumers, primary data collection from consumers and physicians, and sophisticated statistical analytic methods to understand the business of health care. Also residing in i3 Magnifi are its suite of data products drawing on robust information assets. i3 Magnifi will be led by William Crown, Ph. D., a nationally recognized health economist and outcomes researcher who has been leading i3's outcomes business for several years.
"i3 Magnifi leverages i3's health care data assets and analytic talent to work with our clients along nearly the entire pharmaceutical value chain, ranging from initial market assessment, to burden of illness and product differentiation studies," said Dr. Crown.
About i3
i3, a global Ingenix company, provides integrated scientific strategies and solutions throughout the pharmaceutical product lifecycle. It comprises i3 Research, a therapeutically specialized contract research organization; i3 Drug Safety, engaged in drug safety and epidemiology; i3 Statprobe, a technologically focused provider of comprehensive data services; i3 Pharma Resourcing, a world-class staffing partner; i3 Magnifi, delivering the science and solutions to achieve marketplace success, and i3 DLN, providing continuing medical education. i3 helps companies gain sharper insights that lead to better patient care. For more information, visit www.i3global.com.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.