April 2017

Wearable devices are currently growing hugely in popularity, with predictions that the market will grow to $25 billion by 20191. Many of these devices, like the FitBit or Jawbone, are fairly cheap and affordable to the public. With the rising prevalence of chronic conditions like obesity due to our increasingly…

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Where and when did Pharmacovigilance begin? Medical remedies have been recognized by mankind for thousands of years, and so have their potential dangers, side effects, and benefits. During the 20th century there were some serious adverse events associated with medical products and drugs that resulted in pressure on governments, businesses…

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In any clinical trial conduct, recording and storing data in a controlled, consistent, and reproducible manner for data retrieval and analysis is a necessity for regulatory compliance and clinical study success.

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The ICH Guidelines for Good Clinical Practice (E6) has morphed into the international standard for clinical trial conduct since its inception twenty years ago. However, within that period, clinical research has changed dramatically and it is a credit to it’s authors that ICHGCP remains relevant today, with only one previous…

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Outsourcing as a business practice has been around for centuries and some economists would argue it has been around since man first started providing services to one another. The concept is based on the premise that a specialist company that focuses on a specific functional area can do a better…

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Establishing robust metrics at the start of a study, and systems to monitor them in an ongoing manner, should be integral to all work that a Clinical Research Organisation (CRO) performs. There is an expectation from clients that metrics will be used to monitor progress or lack of progress, including…

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Wearables and mobile health (Mhealth) apps collect subject/patient data from mobile or purpose built devices to record data in real time. The rationale behind this type of technology is to reduce the burden on subjects by eliminating unnecessary procedures, streamlining routine procedures and reducing time spent at clinical trial sites….

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A number of team members were able to represent Quanticate at the PhUSE 2016 annual conference in Barcelona. The PhUSE annual conference is an opportunity for programmers and statisticians to both learn from and share cutting edge knowledge with the pharmaceutical industry. This year, Quanticate presented on producing high quality SAS…

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With a growing trend towards the use of risk-based monitoring, and with new technologies available to support this alternative to traditional onsite monitoring, there remains inertia to implement this approach. Having discussed remote monitoring capabilities with industry peers, we have identified the root cause of this reluctance as an intrinsic…

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If a pharmaceutical, biotech or medical device company outsources its clinical trials, it may be neither practical nor advisable to use one single Clinical Research Organization (CRO). Smaller CROs may not have the infrastructure to deliver large multinational trials, and large CROs may not offer the level of attention or…

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