Cary, NC – (April 13, 2010) – Cetero Research, the leading early-stage contract research organization (CRO), today announced it has completed more than 500 diabetes research studies in the past three years for both Type 1 and Type 2 diabetics, including complex clamp studies and studies in Phase I, II, III and IV. Cetero is the only CRO that can combine both pivotal pharmacokinetic studies and proof-of-concept studies in one study, saving up to six months of development time.
“Approximately eight percent of the U.S. population struggles with diabetes, and the numbers continue to grow. Our ability to provide researchers with the support they need to expedite new drug development is extremely important,” said Dr. Troy McCall, CEO of Cetero Research. “According to the Pharmaceutical Research and Manufacturers of America (PhRMA), there are a record number of diabetes drugs in development to help the 20 million Americans battling this disease every day. We want to help get those treatments through proof-of-concept faster by providing a full range of services to pharmaceutical companies.”
Cetero has the capability to run first-in-human, pivotal pharmacokinetic, and proof-of concept studies in diabetics across three of its clinical facilities. Its experience conducting more than 500 diabetes studies in the last three years has given Cetero a keen understanding of the complexity of this type of research.
In one recent diabetes study for a global pharmaceutical company, Cetero randomized the first subject less than three weeks after screening began. The final one of the 56 subjects was randomized just 13 weeks after the first screening. Understanding recruiting best practices and ensuring the recruitment database is current allows Cetero to respond quickly and keep trials on track, even for larger studies.
“One of the biggest challenges in clinical trials is being able to recruit participants and start studies on-time. Cetero’s multi-site capabilities and large participant database help keep the launch of our clients’ trials on schedule,” said Alan Copa, PharmD, President of Clinical Operations for Cetero Research. “We are very proud of our 99% on-time study start-up rate. But we don’t stop there. We are also committed to keeping our clients updated on trial progress, even when we are managing studies across multiple locations.”
Cetero maintains recruiting strategies to build their database of more than 22,000 potential study participants. These factors ensure studies are fully recruited, and start and conclude on-time or ahead of schedule. Cetero also works with one of the largest endocrinology physician practices in the United States, which provides Cetero and its clients with access to more than 30,000 additional patients.
Cetero sets itself apart as a diabetes research partner through its extensive experience conducting clamp studies. In the past three years alone, Cetero’s San Antonio facility has conducted more than 30 clamp studies including hyperglycemic, euglycemic, and hypoglycemic clamps to test for insulin sensitivity and glucose metabolism.
About Cetero Research
Cetero Research is an industry leading contract research organization (CRO) in early stage research services. With more than 25 years of experience from its founding companies, Cetero has conducted more than 10,000 clinical pharmacology studies – more than any other CRO. Cetero’s proven track record allows the company to provide flexible and high quality drug development services, and its time-tested systems produce consistent and reliable data Cetero’s clients can trust. Cetero’s clinical research expertise consists of traditional early-stage, healthy-volunteer clinical pharmacology and bioavailability studies, as well as specialty Phase Ia/b trials in patients. Its bioanalytical services support clinical, preclinical drug and biomarker analysis for small and large molecules. In addition, Cetero owns and operates a full-scale central laboratory supporting Phase I-IV clinical trials in North and South America. For more information, visit www.cetero.com, or call 877.7CETERO.
