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The EMA has published a four-page document to summarize its main achievements relating to marketing authorizations of new medicines and the safety monitoring of authorized medicines during the past year.

Traceability plays a crucial role in ensuring the integrity of source data and in reinforcing clinical research results. CDISC has developed Trace-XML as an extension of its Define-XML model for delivering clinical data lifestyle traceability from data collection through to final analysis.

A recently completed analysis conducted by the Tufts Center for the Study of Drug Development stated that physicians and nurses only refer a fraction of their patients for clinical trials.

While patient centricity has been a newfound goal of the pharma industry, many would argue that adopting this philosophy has been more talk than action thus far. eClinicalHealth conducted a case study to learn what patient engagement means to industry professionals.

A patient-centered study design can improve the trial experience by engaging directly with patients. QuintilesIMS recently completed a case study that supported this concept and showed value toward patient recruitment.