Breaking down the silos using the digital data flow

Have you ever considered where the digital data flow of a clinical study nowadays starts and where it could start? Actually, information generation for a clinical study starts with the drug development planning phase, where we define what studies to perform and how. We start with a study’s main design concepts: objectives, endpoints, indication, interventions, blinding, and more. Once the protocol is written, more details are added and the full study path is laid out. Thereafter, additional operational aspects and data collection details are added to the data flow. All of this put together, already a lot of design and meta information is available before the start of the actual study.
Nowadays, this pre-study information is mainly stored as text and fragmented pieces of information in documents and unlinked databases. What if all this data was digitized and linked? Would it be possible to work together on one single combined data source without the risk of compromising each other’s work?

In this 30-minute Break & Learn session on 06 December, Berber Snoeijer will demonstrate how the recently published CDISC USDM data model* can help store this information in a standardized data structure, how this can inform downstream processes and how different departments can work together on the same linked data source. Achilleas Zaras from eClinical solutions will share some examples of the latter using the elluminate data platform and different user solutions.