Mitigating Risk, Improving Results: A Better Approach to Protocol Deviations
Webinars
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.
* The CDISC USDM data model is developed in cooperation with the TransCelerate Digital Data Flow initiative.
Presenters
Business Consultant, ClinLine
Berber Snoeijer started in clinical research in 1997 as a biometrician and has since then worked with clinical data in different functions. In 2001 she started a CRO, Biometrics Support, aiming at the data management, data analysis and reporting of clinical trials. She switched in 2011 to work as a R&D manager dedicated to investigate and utilize the potential of real world data from electronic health records. This resulted in many different solutions including a full reporting system to give feedback information to clinical research professionals. She is experienced with software and database engineering, process engineering, and improving efficient utilization and interactions of people based on management drivers. Nowadays, she uses these skills and knowledge to help life science companies assess, design, and improve business solutions and processes at smaller and larger scales.
Senior Manager, Solution Consulting, eClinical Solutions
Achilleas has 12+ years of experience in software industry involving software demonstrations, managing a team of 15+ developers, hands-on coding in Microsoft .Net platform and Business Intelligence Suites like QlikSense. He has enjoyed a progressive career in diverse roles including responsibilities of a Sales Engineer, Team Manager, Software Engineer and Business Intelligence Analyst in various industries like Banking, Retail and now the Pharmaceutical industry with eClinical Solutions.
