IRT Integration and Data Flows

Carly Newhardt, Portfolio Director at Yprime
Jason Williams, Senior Manager, Clinical Systems at Takeda
Jody Fermin, Associate Director, Clinical Supply Operations at Otsuka
Natalie Nicholson, Associate Director, Global Clinical Drug Supply Systems at Genmab
Evan Slotter, Associate Product Management Director, IRT at IQVIA Technologies

IRT Integration and Data Flows

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What does the future for sites and patients with integration look like?
What is driving sponsor interest in eClinical platform integration and what are the concerns?
Examining the workflow:
Where does IRT sitting amidst the whole eClinical system data flow?
Where is it necessary and/or suitable for IRT to integrate?
Ideal set-up: does all data need to flow through the IRT portal?
What is appropriate to capture in IRT vs in EDC/eCRF/CDMS systems
Leveraging APIs to permit single sign on authentication for users
Centralized data hubs:
What is it, what are the advantages and how does it work?
Will a centralized data repository get you submission ready quicker?
How can smaller companies set up something similar and derive a similar benefit?
Impact on IRT Professionals - Industry Interactive Poll Time: How many people in the audience have background in IT? How many people oversee more than IRT ie. eConsent; EPro; Forecasting etc
How is the move towards integration affecting IRT professional development?
Do IRT folk now need to be experts in other e-clinical systems?
Practical resources to get equip with information on wider e-clinical systems

Speakers

Carly Newhardt is a Portfolio Director at YPrime overseeing the successful delivery of IRT systems for pharmaceutical partners. Carly has over fifteen years of experience in the clinical trial industry, starting her career as a SAP Supply Chain Demand Planning Consultant before moving into an IRT software design role. Additionally, she managed clinical review and analysis software upgrade, installation, and usage at the FDA and other pharmaceutical companies before joining YPrime as a senior member of its IRT Operations team. Carly earned a Bachelor of Science degree in Industrial Engineering with a Minor in Business from Lehigh University.

Natalie is an RTSM professional with 15 years industry experience with a background in medicinal chemistry and molecular pharmacology. Natalie is currently an Associate Director within Global Clinical Drug Supply team at Genmab. She is passionate about clinical research and the use of technology to best support the protocols that will ultimately improve the lives of patients. is an RTSM professional with 15 years industry experience with a background in medicinal chemistry and molecular pharmacology. Natalie is currently an Associate Director within Global Clinical Drug Supply team at Genmab. She is passionate about clinical research and the use of technology to best support the protocols that will ultimately improve the lives of patients.

Evan has over 16 years’ experience in IRT system design, development, and operations management. He has focused on bringing standardized component libraries and end-to-end solutions to enable more robust and efficient operations for clinical trials. He brings more than 30 years of experience within eClinical technologies, pharmaceutical and Integrated Circuit industries. In his current role, Evan is working on clinical trial technology solutions enabling decentralized clinical trials, direct to patient and harmonizing patient data capture in areas around IRT, eCOA and eConsent.

Over 20 years’ experience in the clinical supply space
Began pharmaceutical career through a clinical supply packaging provider and held various positions from Quality Assurance, Distribution Manager, Project Packaging Manager, Packaging Design and Contracts Manager
Provided various services through Jeiven Pharmaceutical Consulting in project management and clinical supplies
Directs the IRT, EDC/eSource and overall various integration programs along with the clinical supply chain logistics from manufacturing through the life cycle of the clinical products