Category: Our current thinking


EDG & RWD/RWE …

February 25, 2019 | 0 Comments

LSCP “Format Free Initiative” (FFI) gets traction A solid EDG Data Strategy starts … We have to get organized in a different way. Valuable data is extracted from your Digitalization processes. New data sources are being merged with legacy data. The amalgamation of data needs to make good business sense as well as regulatory sense. Regulators like FDA & EMA have recently published their views about what and how they would consider data to be relevant.
EDG drives …

November 1, 2018 | 0 Comments

Creating a Holistic View & Use of Enterprise Data We need to take a holistic view. We have noted that participants and collaboraters in Clinical Trials speak another professional language, different from the manufacturing floor and/or the Patients/Providers (RealWorld Data). Authors need to be understood by reviewers/approvers, users and recipients. Business data need to have value within and across all functions, usable/re-usable everywhere – globally.
EMA IDMP+ EDG Brexit Reflections

August 1, 2018 | 0 Comments

How important are Product Information (PI) DATA Assets in your planning & day-to-day work? The following was published yesterday, in context of a up to 30 % HR and Knowledge Drain after a press conference by Prof. Guido Rasi, EMA CEO.