Open AccessClinical operations generation next… The age of technology and outsourcing
Author(s) -
Priya Temkar
Publication year - 2015
Publication title -
perspectives in clinical research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.649
H-Index - 8
eISSN - 2229-5488
pISSN - 2229-3485
DOI - 10.4103/2229-3485.167098
Subject(s) - outsourcing , automation , food and drug administration , cloud computing , business , engineering management , process management , computer science , risk analysis (engineering) , marketing , engineering , mechanical engineering , operating system
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.