Cary, NC – (May 11, 2010) – Cetero Research, the leading early-stage contract research organization (CRO), today announced it has completed its 50th definitive TQT trial in the last eight years. Cetero’s specialized experience conducting these complex studies assures its clients accurate cardiac safety assessments with an accelerated timeline. In addition to TQT studies, Cetero has performed numerous early phase trials with intensive cardiac monitoring.
“There are a lot of pitfalls that can happen in TQT testing including inappropriate doses, failure to properly calculate correction factors, improper placement of electrodes, and not controlling the setting to ensure a consistent heart rate in the subject,” said Dr. Troy McCall, CEO of Cetero Research “Cetero has a proven track record of navigating around these challenges to minimize risk and ensure reliable data.”
With 50 definitive TQT trials completed, Cetero has successfully recruited more than 5,300 cardiac safety trial participants. Its largest TQT trial to-date included 280 participants at one site. Cetero’s ability to accommodate large trials in a single location means the fewest number of study groups and faster completion rates for studies, ultimately resulting in lower costs and quicker access to critical safety data.
Since the ICH E14 guidance was formalized, virtually every major regulatory agency around the world – including the FDA, EMEA and Health Canada – requires that every new drug has a TQT trial performed. Even drugs that have been approved, but are changed or have a new dosage form developed, may require a TQT study.
“Because TQT data is now so important to the drug approval process, it is important that drug companies select the best partner to provide accurate results in the most efficient manner. There are so many variables and critical design elements that can impact the outcome of a study – and ultimately the approval or rejection of a drug candidate,” said Alan Copa, PharmD, President of Clinical Operations for Cetero Research. “Cetero’s unparalleled knowledge of the nuances of TQT studies can help in early stage drug development to inform critical decisions at the start of the development cycle as well as late stage development that requires effective collaboration and data collection.”
In addition to specialized TQT trials, Cetero’s study experience includes early stage clinical trials related to asthma, allergy, dermatology, diabetes, renal and hepatic impairment, hypertension, neuropathy, osteoporosis, hypercholesterolemia, obesity, menopause, and nephropathy.
About Cetero Research
Cetero Research is an industry leading contract research organization (CRO) in early phase 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.
