title: Data management Redefined.
abstract: Core perspectives on the traditional approach to CDM are rapidly changing and EDC and new eclincal initiatives are redefining the face of data management. Associated with EDC are not only the higher efficiencies, resulting in lower study costs, but its applications in key areas such as adaptive trials and clinical event adjudication; however the cost and effort involved in deployment and integration remain a deterrent. The role of the data manager may change to that of a data broker who manages the exchange of data from multiple sources, and semantic interoperability, data standards and data privacy will prove to be the defining factors. Simulation modeling, pharmacogenomics, personalized medicine and EHRs will no longer exist as silos and seamless data flows will be the drivers of healthcare solutions.
authors.affiliation: VP and Global Head, Strategic Data Services and Medical Writing, SIRO Clinpharm Pvt. Ltd. & Vice-Chair, Society of Clinical Data Management.
authors.forename: Nimita
authors.initials: N
authors.lastname: Limaye