Implementing SOA and Metadata Governance for the Clinical Development Lifecycle using Semantics Manager

[Whitepaper]defining development process governance implementing adam WEBVIEW lg

This whitepaper discusses the current state 2013-2014 of the clinical development lifecycle (CDLC) and how the enhancement of scientific capabilities still has much room for growth and improvement in order to achieve the industry goals of greater innovation, more efficient safety evaluations, improved data handling, and compliance with ever-changing regulations.

Over the last decade, the number of new technologies that automate many of the former paper-based processes like electronic data capture, electronic document management, and electronic master file systems has increased significantly.

Although these point technologies have the potential to improve individual processes if used properly, the overall clinical development lifecycle has basically remained unchanged, while the amount and complexity of data being collected and analyzed has significantly increased.

To gain maximum reuse of data downstream, cross-study, and for future discovery and innovation, data must be defined more broadly and managed with more granularly.