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Accelerating Development

Over the last 10 years, unprecedented advances in technology have revolutionised how people communicate, collaborate, and transact business, whether paying for groceries, video conferencing with colleagues from around the world, collaborating on editing and sharing documents, or analysing data – all from the palm of a hand. For context on how exponential these advances have been, a smartphone from 2014 is able to process information 100 million times faster than the supercomputers that NASA used to guide the Apollo missions to the moon.

Other industries – even those that are heavily regulated, like the financial sector – have integrated technology into their business models to automate processes and are using predictive modelling for better decision making. However, why not the pharmaceutical industry, especially now, when clinical trial performance benchmarks reveal an industry that is performing worse overall than a decade ago. So why is pharma slow in adopting new technologies to reverse these trends?

A Broken Model

Between 2005-2015 the number of countries involved in Phase 3 clinical trials has doubled, and the number of investigative sites has increased by 63%. Simultaneously, the mean number of patients declined by 18%, adding complexity to study startup processes (1). For example, site selection and initiation now takes an average of nearly eight months – longer than it did a decade ago – as more researchnaïve sites are being used. 28% of sites engaged represent new relationships with the sponsor or CRO, which adds 9.9 weeks to site initiation timelines compared to when the sponsor or CRO has a pre-existing relationship with the site (2).

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Brion Regan has over 13 years of industry experience and has established himself as a thought leader in the application of data-driven process optimisation and cloud-based technologies to the clinical research space. As the Director of Product Management for ERT’s Trial Oversight Suite, he is leading the commercial development and management of the company’s growing portfolio of Software as a Service solutions. Prior to ERT, Regan served on the executive leadership team at technology start-up eClinical Insights as Head of Strategic Development. He has also previously held various positions in product marketing and business development at PharmaPros Corporation.
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