Case Study: Solving Unique Challenges in Oncology Trials Using Advanced IRT Functionality

Oncology trials have unique requirements that can present challenges for interactive response technology (IRT) systems. An advanced IRT system that has the flexibility to handle unique aspects of oncology studies can simplify the complexity of managing such studies and dramatically reduce the burden on the sponsor. To implement a flexible IRT system successfully, it’s important to look at new ways to approach system functionality that can account for the “known” unknowns that make oncology trials especially difficult to design and maintain.

This webinar will go through Celgene’s clinical protocol in case study format and how Suvoda’s IRT system helped simplify complexities while addressing specific business needs. The webinar will cover aspects of the clinical protocol that are traditionally obstacles for IRT systems and solutions for those obstacles. The webinar will then evaluate the success of the flexible IRT system design one year after deployment.

Register for this webinar to learn how Suvoda helped Celgene design a system that is flexible enough to handle:

• Subject-specific dynamic visit schedules to manage an unknown number of repeating cycles
• Unknown cohorts and cohort doses
• Unknown number of unscheduled, dose titrating visits
• Multiple phase management with different disease/tumor type management per phase

Speakers

Lisa Li, Director of Services, Suvoda

As Director of Services at Suvoda, Lisa has global responsibility for project management, account management, and IRT services delivery for Suvoda’s customers. Lisa has a decade of experience in the delivery of eClinical software; holding a variety of roles with responsibilities in project management, business requirements analysis, and management.

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Heather Nonnemacher, Project Manager, Suvoda

Heather is a Project Manager at Suvoda. She leads a cross-functional team in creating Interactive Response Technology (IRT/IWRS) systems for clinical trials, allowing study teams to more efficiently manage their drug supply and patient randomization. She has worked with a variety of pharmaceutical and biotechnology sponsors as well as global CROs on a range of indications including, oncology, cystic fibrosis, Alzheimer’s and vaccines. She has a BA in Public Health and Biology from Franklin & Marshall College.

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Racquel Mangaser, Lead Analyst, IVRS Central Management, Celgene

As part of Celgene’s IRT Central Management, Racquel serves as a main contact, vendor manager, and SME for study teams’ system development and maintenance. In her current role as Lead Systems Analyst, she also manages budgetary responsibilities, maintains IRT-related processes and documents, and evaluates provider performance. Prior to joining Celgene in 2008, she was on the IRT provider side in Clinical Project Management for several years.

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