Bio-Kinetic Clinical Applications, the early-phase clinical research unit acquired in February by US-based contract research organisation (CRO) QPS, is collaborating with fellow CRO Quintiles Transnational to offer an integrated Cardiac Safety Service for clinical trial sponsors.
The collaboration will provide a full-service, single-point solution for Thorough QTc (TQT) studies, from the first regulatory strategy through to generation of the final clinical study report, the companies announced.
Usually conducted in the early phases of drug development, TQT studies are cardiac safety trials that look at a drug’s impact on cardiac repolarisation by identifying and quantifying any prolongation of the QT/QTc interval (markers of increased susceptibility to cardiac arrhythmias).
With cardiac safety concerns a prime cause of drug withdrawals and restrictions on indications, as well as a barrier to marketing authorisations, regulatory authorities around the world now ask for additional cardiac safety testing, based on the International Conference on Harmonisation’s (ICH) E14 guideline on the clinical evaluation of QT/QTc interval prolongation, when a positive signal for QT prolongation emerges in preclinical development.
The formal collaboration between Bio-Kinetic and Quintiles on cardiac safety is the culmination of a more than 10-year relationship involving a number of Phase I trials, including TQT studies, the partners noted.
In line with current trends in TQT research, they said, QPS’s and Quintiles’ Phase I units can enrol large cohorts of subjects, as are commonly required for parallel group designs; conduct trials in the US and/or Europe; and provide first-in-human clinical environments when the safety of the test article is not adequately defined. Together they manage 550 Phase I beds at research facilities in Springfield (Missouri) and Overland Park (Kansas) in the US, London in the UK and Uppsala in Sweden.
Also on offer is a global core electrocardiogram (ECG) service, comprising a state-of-the-art analysis laboratory with high-throughput capability, paperless operation and in-process quality control of ECG reading and verification, manned 24/7 by full-time cardiologists and operational staff. A clinical pharmacology team can provide ancillary services from data management through to report writing, as well as concentration-QT (C-QT) modelling and simulation used to interpret more accurately the results of TQT studies.
Based in Newark, Delaware, QPS specialises in in vivo/in vitro drug metabolism testing, preclinical absorption, distribution, metabolism and excretion (ADME) studies, pharmacokinetics, protein binding, whole body autoradiography, molecular biology, immunogenicity testing and biomarker assays.
