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Cetero Research, an early stage CRO, announced it has completed its 50th definitive TQT trial in the last eight years. Cetero’s specialized experience conducting these studies assures its clients accurate cardiac safety assessments with an accelerated timeline. In addition to TQT studies, Cetero has performed 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.
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. .”
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.