The pharmaceutical industry faces pressure to improve the drug development process while reducing costs in an evolving regulatory landscape. This paper presents the Preclinical Information Center ...

The integration of a Clinical Metadata Repository (CMDR) and a Clinical Data Repository (CDR) presents the opportunity to maximize automation across the end-to-end clinical trial lifecycle. It also ...

Outlining the techniques for anonymization of clinical study reports and the identification and redaction of commercially confidential information to comply with EMA's Policy 0070 on trial data ...

With the implementation of Article 57(2) in 2012 the European Medicines Agency (EMA) embarked on a digitalization journey that foreseeably would ensure greater product oversight and interoperability ...