title: 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.
authors.affiliation: Business Consultant, Clinical Services - Life-Sciences, Tata Consultancy Services, Mumbai, Maharashtra, India.
authors.forename: Priya
authors.initials: P
authors.lastname: Temkar
keywords: Analytics; clinical operations; cloud; current trends; electronic source; mobility; outsourcing; social media; technology