With the development of world-class R&D infrastructure by Quintiles over the past ten years, Asia in general, and India in particular, is seeing the evolution of a culture of innovation. With the balance of pharmaceutical investment and innovation already seeing a shift towards Asia, India is uniquely positioned as a center for innovative excellence.
Quintiles Cardiac Safety Services, based in India, is an excellent example of a Quintiles unit that has more than matched its promise as a higher value service provider. Presently, it is poised to assume the mantle of a strategic partner of choice for global pharmaceutical companies who are seeking cardiac safety solutions. Going beyond simply providing cardiac safety evaluation data during drug development, it has gained the experience and infrastructure needed to expand its ability by fostering innovation that moves higher and higher up the value chain.
In the rapidly evolving field of cardiac safety evaluation of new drugs, QCSS formulated a strategy of developing an active cutting-edge research program to reach a position of knowledge leadership, ahead of other core ECG laboratories. Its research team focused on the various practical aspects of cardiac safety research such as:
- Evaluation of different techniques in acquiring digital ECGs (Original research paper titled ‘Differences between QT and RR intervals in digital and digitized paper electrocardiograms: contribution of the printer, scanner, and digitization process’ published in Journal of Electrocardiology. Read the article on the Journal of Electrocardiology website)
- Devising methods for benchmarking competence of readers involved in the analysis of ECGs (Original research paper titled ‘Differences between QT and RR intervals in digital and digitized paper electrocardiograms: contribution of the printer, scanner, and digitization process’ published in Annals of Non-invasive Electrocardiology. Read the article on the Annals of Non-invasive Electrocardiology website)
- Assessing the regulatory issues pertaining to cardiac safety in early drug development. (‘Update on the evaluation of a new drug for effects on cardiac re-polarization in humans: issues in early drug development’ published in British Journal of Pharmacology. Read the article on the British Journal of Pharmacology website)
- Assessing the optimum number of ECG replicates for a TQT study in the context of power calculations and associated cost implications. (Original research paper titled ‘Effect of Number of Replicate ECGs Recorded at Each Time Point in a Thorough QT Study on Sample Size and Study Cost’ published in Journal of Clinical Pharmacology. Read the article on the Journal of Clinical Pharmacology website)
In the past five years, more than 35 abstracts have been presented at various conferences organized by eminent bodies such as the Drug Information Association, Cardiological Society of India, International Congress on Electrocardiology, IEEE Computing in Cardiology, etc . These conferences were attended by academics, representatives from other core laboratories and medical professionals from the pharmaceutical industry. These papers have invariably evoked great interest and active discussion on stage as well as off the stage, asserting the growing eminence of Quintiles Cardiac Safety Services as a thought leader in the field of cardiac safety.
A compilation of the body of research findings generated by Quintiles Cardiac Safety Services may be accessed here: QCSS Research Booklet