Sheelagh has over 30 years’ experience in clinical data management. She holds a BSc in Pharmacology and obtained a doctorate in Pharmacokinetics from the University of Bath, UK. Following completion of her academic studies, Sheelagh moved into the pharmaceutical industry, working for large, medium and small CROs, heading up data management and programming groups. Sheelagh established her own bespoke data management CRO which she ran for 16 years, conducting studies for multinational pharma and biotech companies alike. She has been involved in all phases of clinical trials across many therapeutic areas, from the large pharmacogenomic studies to the small cell therapy and ATIMP studies. Sheelagh has lead PHASTAR’s Data Management group since 2016.
I am currently a Manager in Clinical Data Operations at Phastar, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services. I have been in the Clinical research industry for over 20 years in the areas of Data Management and Clinical trial supplies spending almost 10 years in the area of Allergy and Respiratory medicine working across a number of large innovator Pharma companies as well as one of the largest global Generics companies.
Title of Session: Data Management’s role in Multi Stream Data Capture
Description of Session:
Data collected in the by traditional means of EDC systems utilizing libraries of eCRFs is becoming a smaller proportion of the data required to be collected, as defined by the protocol and the required data for analysis by our statistics partners. The advent of wearables and the utilization of electronic health records with the millions of data points collected will reduce the proportion of ‘data entered’ data further in the future. Clinical trials now often have multiple data streams collecting efficacy and safety end points, a recent survey showed that one trial run had in excess of 30 different types of data streams collected in one clinical trial.
So how will we as data managers ensure the integrity and accuracy of that data and reconcile across multi types and sources of data? How do we define ‘source’ and how will we ensure that changes are captured and audit trails are regulatory compliant and available for all types of inspections.
This session will share best practice and highlight practical strategies of handling these new data types in traditional clinical trials with multiple data sources, working with multiple vendors and differing key data sources. This also gives all an opportunity to share learnings across this topic and discuss the vision of the future with the advent of new technologies in this area.
Best practice guidelines for handling multiple data streams/sources
Opportunity to share learnings of handling multiple sources of data across delegates
Vision of future of Data management techniques and possible new technologies to help in this area