The Benefits of a Seamless IRT and EDC Integration in Clinical Trial Execution

There’s a lot of discussion around the benefits of a unified platform, or one-stop-shop for eClinical solutions (Electronic Data Capture [EDC], Interactive Response Technology [IRT], eConsent, electronic Patient-Reported Outcomes [ePRO], etc.). While a single platform may satisfy the needs of smaller studies, what happens when your studies become larger and your protocols become more complex? Increasing complexities often force study teams to start looking for multi-vendor approaches.

Two software companies have combined their offerings into a powerful streamlined integration with the convenience and simplicity of a single solution, without sacrificing the advanced functionality of standalone systems. This integration accommodates advanced study designs while driving down build and casebook complexity.

Hear directly from the sponsor, Cara Therapeutics, on the benefits they’ve seen in their studies by moving from a single provider to a harmonized, best-of-breed approach. The discussion will also include other examples illustrating how both companies support patient cohort branching, treatment cycles and system integrations.

Speakers

Scott Dixon, Global Vice President, Strategic Partnerships, Suvoda

Scott Dixon has spent his entire career in the life sciences technology industry, holding senior leadership positions at companies including ERT, Oracle, Phase Forward, WebMD and Parexel. As global vice president of strategic partnerships at Suvoda, Scott is responsible for developing strategic initiatives for sales and business development, as well as establishing and enhancing Suvoda’s business partnership relationships. Scott is a versatile leader with a proven track record in consistently delivering new product and market strategies for startups and Fortune 100 companies in the life sciences and healthcare software application industries. He holds a Bachelor of Science in Biochemistry from the University of Georgia.

Message Presenter

Ami Dudzinski Mehr, Vice President, Vault CDMS Services Sales & Strategy, Veeva Systems

Ami Dudzinski Mehr is a results oriented senior leader with over 20 years of Professional Services experience. Ami has devoted her career to implementing EDC and IRT/IVRS software for clinical trials. Ami is currently part of the Vault CDMS leadership team and responsible for Services Sales and Strategy. Prior to this role, she built and led the services organization. Earlier in her career she was responsible for trial build and enablement delivery at Oracle and Phase Forward. Ami holds a B.A. in the Mathematical and Physical Sciences from Wells College and Leadership Certificate from the Simmons School of Management.

Message Presenter

Catherine Munera, Ph.D., Head of Biometrics, Cara Therapeutics

As Head of Biometrics for Cara, Dr. Munera leads the data management, programming and biostatistics functions, supporting the clinical development programs for the oral tablet and intravenous formulations of Difelikefalin. Dr. Munera has extensive experience in the development, operations, analysis and reporting of clinical trials, with therapeutic expertise in immunology and metabolic areas. Prior to joining Cara Therapeutics in 2015, Dr. Munera acted as Director of Biostatistics and Programming at Purdue Pharma where she implemented innovative trial designs and analyses that led to several successful clinical trials and was part of the company’s Due Diligence team. She was the lead statistician or has supervised four successful New Drug Applications in the fields of anti-infectives and chronic pain. She also held positions at Genentech and Bayer. Dr. Munera earned her Ph.D. in Mathematical Statistics from Columbia University.

Message Presenter