Clinical operations generation next… The age of technology and outsourcing

Abstract

Huge cost pressures and the need to drive faster approvals has driven a technology transformation in the clinical trial (CT) industry. The CT industry is thus leveraging mobile data, cloud computing, social media, robotic automation, and electronic source to drive efficiencies in a big way. Outsourcing of clinical operations support services to technology companies with a clinical edge is gaining tremendous importance. This paper provides an overview of current technology trends, applicable Food and Drug Administration (FDA) guidelines, basic challenges that the pharma industry is facing in trying to implement such changes and its shift towards outsourcing these services to enable it to focus on site operations.

Trial Promoter: A Web-Based Tool for Boosting the Promotion of Clinical Research Through Social Media

“…This is especially relevant in light of the high operational costs associated with clinical trials [4,27]. Nearly 30% of the time dedicated to clinical trials is spent on promotion, patient recruitment, and enrollment [28].…”

Cloud IoT as a Crucial Enabler: a Survey and Taxonomy

“…These sources are ranging from academic going to industrial and ending with commercial worlds (George Pallis, 2010). While GC delivers storage and/or compute resources, CC delivers more abstract resources and services via abstract interactive interfaces that can yield long-term cost benefits and improving productivity (Foster et al, 2008) (Naveen and Harpreet, 2013) (Temkar, 2015) (Ashdown and Kyte, 2015) (Ashdown, Kyte and McCormack, 2018).…”

“…As CC is truly becoming a competitive business model that transforms the way enterprises are doing their business, it involves many tools to automate processes in a different way and achieve faster turnaround time (Temkar, 2015) (Essandoh, Osei and Kofi, 2014). Going further, as this business model draws the milestones of the economic strategy and operational modes of any enterprise, any business that doesn't keep up may be left behind.…”

“…However, the existing obsolete approaches should be eliminated inside this new competitive environment. One more thing, besides that this new environment essentially involves advanced tools, techniques, frameworks, and methodologies (Chaudhari and Patel, 2017) (Gholami, Daneshgar and Beydoun, 2017), it may also involve automating many processes inside (Pooyan, Ahmad andPahl, 2013)(Yashodha Sambrani, 2016) (Temkar, 2015). For the reason that there is a necessity for new solutions to work smoothly with already existing systems, compatibility is another significant enabler that greatly influences the adoption of CC (Essandoh, Osei and Kofi, 2014) (Gholami, Daneshgar and Beydoun, 2017) (Ali, 2016).…”

“…Just as the industrial revolution progressively alienates labors from the revenue of production and creates an imbalance in authority structures, CC is regarded as a player with a significant role in enabling greater reengineering of the software industry (Filippi and McCarthy, 2012). As it is the next stage in the Internet's evolution, gathered under the name "cloud computing", the software industry continues shifting towards service-based business models that increase productivity, shrink timelines, reduce the long-term operational and maintenance costs, and allow an enterprise to focus on its core activities rather than trying to solve computer automation problems (Temkar, 2015) (Aspen and Kaitlyn, 2017) (Arora et al, 2017).…”