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Fastening Pharmaceuticals

As consumers increasingly embrace the more affordable nature of wearable devices – choosing to monitor their own health and wellbeing with gadgets such as FitBit or Jawbone – it is no surprise that the wearable device market is set to grow to £25 billion by 2019 (1). However, this wearable technology has also been widely adopted by other markets, and none more so than by the healthcare industry, which reportedly earned revenues of $5.1 billion in 2015, according to a recent report by Frost and Sullivan (2). This wearable devices market is set to continue to revolutionise the healthcare industry with estimates that it will reach over $18 billion by 2020 (3).

It has been widely reported that CROs can leverage this wearable device trend to enable easier remote patient monitoring, improved therapeutic outcomes and deeper insight into clinical studies. Alongside this, traditional outsourcing in the area of clinical trial data management is seeing notable increases in market concentration, while speciality service providers are experiencing unprecedented growth. The Tufts Center for the Study of Drug Development estimates that, since 2011, small niche or speciality service providers have enjoyed strong relative annual growth, approaching 10% (4).

However, the clinical trial process is known to be complex, painstaking and is often criticised for not being sufficiently patient-centric. Therefore, it makes sense to innovate in this area to ease the challenges, streamline the various activities and generate better patient engagement. One way to do this is via digital technology and mobile health (5).

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Jeremy Wheeler, Head of Statistics at Quanticate, is an experienced statistician with over 25 years' experience, including over 10 years in the pharma industry. He has worked in all phases of drug development, with particular knowledge of clinical studies, early phase design and analysis, methodology/biomarker studies and pharmacogenomics. Jeremy has a strong background in epidemiology and observational studies. He has applied this knowledge to post-marketing studies, meta-analyses and clinical registry studies.
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Jeremy Wheeler
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Strategic Alliance to support efficient, ethical practices in biopharma industry

Hayward, CA and Stockholm, Sweden (07-12-2017) – Two leading drug development and regulatory consultancies announced today that they have formed a new strategic collaboration to help life science companies navigate an increasingly complex global environment. Ethiprax Associates LLC, a leading Compliance and Ethics solutions consultancy based in the US, and NDA Group, a world-leading integrated regulatory/drug development consultancy, are now collaborating to provide the life science industry with truly integrated, trans-Atlantic Compliance-and Risk Management strategies.
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The trial presented to Cmed was a randomized, double blinded, placebo and active controlled study to evaluate the cardiac safety of multiple doses of [study drug] in health volunteers. The pharmaceutical company, who were into the second year of development of a potential blockbuster compound for the treatment of chronic myelogenous leukaemia (CML), were requested by the FDA to design a trial to provide information on the cardiac safety of different dose levels of the study drug in healthy adult volunteers. The primary objective of the study was specifically to find the maximum tolerated dose before QTc levels became unsafe. All development of the compound was put on hold until the results of this study were submitted to the FDA and approval granted for the compound to progress into full development.
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Drug Discovery 2018

21-22 March 2018, Copthorne Tara Hotel, Scarsdale Place, Kensington, London

SMi Group is proud to announce the return of Drug Discovery in 2018. The successful conference will return for its 2nd year on the 21st and 22nd March.
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