Category Archives: Uncategorized

Quality Drivers in Clinical Trial Conduct – Part 2

This study aimed to illustrate how sponsors should measure quality of clinical trials and identify the various drivers of performance.  It was able to actually quantify the magnitude of the relationship between each of the drivers of performance and quality … Continue reading

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Quality Drivers in Clinical Trial Conduct – Part 1

“Quality is never an accident. It is always the result of intelligent effort” (John Ruskin 1819-1900). Quality is an abstract concept and a term with which we are all familiar and tend to take for granted.  It is something to … Continue reading

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AUDIO-VIDEO RECORDING OF INFORMED CONSENT PROCESS_Part 2

In Part 1 we looked at the guidelines [1] for the requirement in India to make AV-recordings of the investigator(s) and patients (and any necessary witnesses/representatives) during the consent process and potential implications [2]. So how, in practice, has this … Continue reading

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AUDIO-VIDEO RECORDING OF INFORMED CONSENT PROCESS_Part 1

Lights, camera, action!  Starring Investigator and trial participants…. Back in November 2013, following a number of scandals in India involving revelations that vulnerable patients were being recruited into unethical clinical trials without proper informed consent, a supreme court order demanded … Continue reading

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An insight into relationships between CROs and Sponsors – Industry survey

The AVOCA group, founded in 1999, is a consulting and survey research firm based in Princeton, NJ. Each year, Avoca conducts industry research to measure current trends in clinical outsourcing and produces a report on the results. This year’s survey, recently … Continue reading

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