CINCINNATI, Dec. 18 /PRNewswire/ -- Medpace, a leading global full-service contract research organization (CRO), is opening a 50 bed clinical pharmacology unit in Cincinnati, Ohio. The Medpace Clinical Pharmacology Unit (Medpace CPU) is a state-of-the-art Phase I, IIa facility, focusing on confined/controlled pharmacokinetic/pharmacodynamic studies utilizing human volunteers, with first-in-man capability.
The Medpace CPU is led by Jean Siebenaler, MD, who has extensive experience in clinical practice and CRO project management. The Medpace CPU will be managed by a team of highly trained, clinical research professionals, who are experts in the design, implementation, and analysis of Phase I and IIa studies. Jim Wei, MD, PhD, will be responsible for reviewing the early Phase studies of sponsors' products, recommending studies, and assisting with Phase I/Phase IIa study designs. Dr. Wei comes to Medpace from the FDA where he served as a Senior Reviewer in the Office of Clinical Pharmacology for almost 10 years where he was heavily involved in reviewing NDAs and INDs for the Divisions of Metabolism and Endocrinology Products.
Aligned with the Medpace approach of providing therapeutically focused clinical development services, the Medpace CPU will uniquely focus on studies in defined metabolic patient populations. The company's dedicated subject recruitment division, together with a strategic partnership with the renowned Metabolic and Atherosclerosis Research Center (MARC) led by Dr. Evan Stein, will facilitate efficient recruitment of populations which include: diabetics (Types I and II), patients with metabolic syndromes and cardiovascular diseases.
The secure, state-of-the-art, 24-hour, 7-day a week facility, features a thirteen bed intensive care/observation unit. The Medpace CPU is located across the street from the Medpace Reference Laboratories, a full service central lab which features therapeutically specialized testing. The site will have a full 12-Lead Mortara Telemetry system with wireless transmission to a centralized monitoring station which can monitor and record up to thirty-two patients simultaneously which allows for thorough QTc studies. The site also has the capacity for IV infusions, Holter monitoring, and pulmonary function testing.
Amenities for the study participants will include single beds, large flat screen TVs, video games, DVD players, desktop computers, wireless internet access, an enclosed outdoor courtyard, full-service catering, and a warming kitchen for in-house meal distribution.
The Medpace CPU is unprecedented in the region for its size and state-of- the-art equipment. Its presence continues to enhance the area's growing healthcare reputation and a commitment to pharmaceutical research.
"We are pleased to offer this state-of-the-art, highly specialized Phase I and IIa facility for our clients," said August Troendle, MD, Medpace Chief Executive Officer. "We believe our therapeutic expertise in cardiovascular, oncology, and metabolic clinical trials will be a unique offering in a market place that has a high demand for Phase I and II studies but rarely specializes in a few areas of focus."
Community volunteers interested in participation may call the unit directly and speak to a recruitment specialist at: (513) 366-3222 or (859) 341-9800.
Medpace is a global, research-based drug development company led by top therapeutic and regulatory experts who are driven to further the advancement of pharmaceutical agents for use in cardiology, metabolism, and oncology. Medpace has assembled the industry's most experienced and therapeutically focused team to execute at every level of the company's operations, providing complete and seamless drug development services.
Through specialized regulatory expertise and therapeutically focused clinical operations, Medpace creates strategic partnerships with pharmaceutical and biotechnology companies to provide the most efficient and cost-effective path to drug development -- from program planning and execution to product approval.
With more than 550 employees and clinical trial experience in over 40 countries, Medpace has the global reach and capability to conduct studies and navigate regulatory requirements worldwide within the core therapeutic areas of cardiology, metabolism, and oncology.
The Medpace group of companies also includes:
Imagepace -- a core imaging laboratory
Medpace Reference Laboratories -- a centralized lab with
therapeutically specialized testing
Medpace Clinical Pharmacology -- a Phase I/IIa unit
View the Medpace website at http://www.medpace.com.
Contact: John Wynne, 513-579-9911 x 2407
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