eClinical solutions: Boosting the clinical trial efficiency

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Vidhya sabbella

Posters: Pharmaceut Reg Affairs

Abstract :

eClinical solutions are a combination of technology, products, and services that work together as solutions to automate the management or conduct of clinical trials with the aim of replacing manual, ad hoc or paper-driven methods. eClinical solutions refer to a number of different technologies, such as EDC solutions (Electronic Data Capture), CTMS (Clinical Trials Management System), Randomization and Trial Supply Management systems, IVRS (Interactive Voice Response Systems), electronic patient diaries and other common types of electronic solutions widely used in clinical trials. Early trends and talk around eClinical focused around how data from disparate systems could be integrated to remove duplication of data and activities. One way in which eClinical has changed the way in which we do business is that integration of key clinical trial systems have become expected rather than exceptional. Vendors and sponsors are investing in infrastructure and standards to ensure capabilities can be scaled up and applications integrated in a rapid, efficient, and supportable manner?like the cargo industry analogy. The market for eClinical solutions can be analyzed with respect to three delivery modes, i.e. licensed enterprise (on-premise), web hosted (on-demand), and cloud-based. eClinical solutions are being used more frequently in upstream site on-boarding and qualification processes, and in managing site-sponsor collaboration during a clinical trial. A large number of investigator groups are still ignorant of the benefits offered by eClinical solutions and continue to depend on paper-based work or spreadsheets. Compliance benefits and user-friendly access of software are yet to penetrate the clinical trial community well.