Durham, NC, USA

Disruptive Changes in the Clinical Trial Data Handling and Analysis Space




This SDE was hosted by PAREXEL on November 9th, 2017 in Durham, NC.  Kerri McCaul Claus, PAREXEL and Karl Konrad, D-Wise were the co-chairs and put together an exciting agenda.  Special thanks to Debbie Johnson, with help from Beth Neece, John Jordan, and Leon Smith who were involved behind the scenes to manage the logistics of the event and to ensure that guests were well taken care of. 

The theme for this event was “Disruptive Changes in the Clinical Trial Data Handling and Analysis Space”, and we had over 90 registered attendees.

Jason Martin, PAREXEL, set the tone for the day with a great keynote touching on innovation within the industry and how historical innovations have helped to shape and drive the present and future of our business.  Morning sessions followed the keynote and talked in depth about the concepts of linked data, Meta-data repository (MDR), and optimizing technology to drive efficiency and cost savings in the healthcare industry.   The morning included a special presentation from FDA speaker Joe Meehan, who talked about tools and techniques that are being developed to help drive improvement in the regulatory review process.

Afternoon sessions kicked off with an update from Chris Hurley on behalf of PHUSE, who shared news and upcoming events for the new year, including the 2018 annual conferences. Afternoon speakers continued with our theme for the day, with a focus on linking metadata and CDISC standards, as well as workflow automation as a means of driving efficiency.  In addition, a macro tool offering a practical solution to managing text strings relative to regulatory requirements was demonstrated.

Lunch and break sessions throughout the day allowed the opportunity for guests to mingle and network, discussing thoughts/perspectives from speaker presentations as well as industry topics in general. Delicious, blue and orange cupcakes capped off the afternoon and were enjoyed by all in celebration of the PHUSE 100th SDE!

The day was concluded with a panel discussion and all the speakers invited to field questions and comments from guests.  Speakers responded to a number of questions and topics, and theorized on potential way forward practices in our industry.  Attendees actively participated and generated some very thought provoking discussions. 

Thanks to all who helped to organize and participate in this exciting event!



Keynore – Jason Martin, PAREXEL

Concept-based Metadata Repository – Breaking Down the Silos – Julius Kusserow, PAREXEL

Moving Towards a Round World: Linking Multi-dimensional Clinical Metadata Across the CDISC Standards – Scott Bahlavooni, d-Wise

Using Natural Language Processing and Text Mining to Identify Key Terms – Joe Meehan, FDA

Digital Innovations in Healthcare: Achieving Organizational Transformations with Technology Optimization – Sameer Thapar, Oracle

PHUSE Update – Mouly Satyavarapu, PHUSE Americas SDE Co-Lead & Chris Hurley, PHUSE Americas Director

Disrupting Clinical Trials with Linked Data – Tim Williams, UCB

Data Visualization Strategies for Anomaly Detection – Heather Stevens, Chiltern

Standards and Ontology-driven Workflow Automation of Clinical Studies – Suresh Madhavan & Jerry Zaborowski, PointCross Life Sciences

A Macro Tool to Find and/or Split Variable Text String Greater than 200 for Regulatory Submission Datasets – Venkata Madhira, Shionogi


Download the event brochure.







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