Cardiac Safety Studies – What You Need to Know

Every Thorough-QT studies specialist should understand the importance that sponsors attach to the quality of ECG data, speed and regulatory compliance. While ECG analysis is very important, data capture in a clinic is imperative. Seeing as it costs the same to produce a good quality ECG as it does to produce a low quality ECG, professionals in this field will seek to get it right at the bedside, thereby allowing everything else to fall into place.

A professional CRO will offer a comprehensive TQT measurement platform, with the design, analysis and implementation of all cardiac safety studies being administered by specialists. What sponsors require is a CRO that combines experience and hands on involvement in every element of the cardiac safety study. Some CROs are so confident about their ability to deliver a successful TQT study that they even go as far as offering a fixed price guarantee. Moreover, the confidence that certain CROs have in their experience means that should they fail to demonstrate Thorough QT assay sensitivity, they would be willing to repeat the study at no cost to the sponsor.
When choosing a CRO for your cardiac safety study, it is important to hire one with the expertise you require. Check that they have a 100% success rate which will come in handy when planning and carrying out your next cardiac safety study. Avoid CROs that have conducted QT studies which have shown a false positive result. You need a research specialist that not only knows what to do, but also knows how to do it. This can be proven by checking to see that 100% of their cardiac safety studies showed assay sensitivity, in other words they just don’t go wrong.
Under One Roof Approach
The “under one roof approach” is another useful factor to consider when selecting a CRO for your cardiac safety study. For instance, you would be better off going for a CRO whose quality of ECGs is renowned to be the best in the industry as certified by the global ECG core laboratory of a top 10 pharmaceutical company. The success of this unique under-one-roof approach stems from the fact that the recording of the ECGs of the CRO is supervised by people who will later read them i.e. the cardiologists.
Geographic Location
It is not important for a CRO to conduct a study in the country of targeted submission. For instance, a CRO does not have to conduct an FDA compliant study in the US. However, if this is important to you, you may want to check that the CRO has had all their cardiac safety studies submitted to the FDA (U.S. Food and Drug Administration), MHRA (Medicines and Healthcare products Regulatory Agency) and MHLW (Japanese Ministry of Health, Labor and Welfare).
Lower Cost
Go for a CRO whose TQT studies have been 100% successful – as this will prove to be less expensive than repeating the exercise again. The CRO should get it right the first time such that there will never be a second time.

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