Thorough QT Success Story
Capabilities
A critical element of clinical research is the planning and execution of a Thorough QT (TQT) clinical study design, which is a requirement for regulatory approvals of New Drug Applications (NDAs) in many markets. Under the leadership of Dr. DePetrillo as Medical Director and Principal Investigator, Pharmaron’s study team provides services that offer our partners assurances that the serial ECG data collected on their TQT study will lead to precise data analysis and a conclusive study result.
This was recently demonstrated in a completed TQT study for Zavante Therapeutics. In this San Diego-based biopharmaceutical company, our team delivered high-quality ECG data, leading to remarkably low variance in data analysis, thereby assuring our client that the results from the study were complete and accurate.
According to David Skarinsky, Vice President of Operations at Zavante Therapeutics, “Pharmaron provided Zavante the expertise of a highly qualified operations team with deep knowledge to design, recruit, conduct and analyze ECG and pharmacokinetic data to deliver an exposure-response QT analysis of drug effect. A true extension of the Zavante team, Pharmaron delivered a critical path study on-time and on-budget.”
Written with permission by Zavante Therapeutics
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