Global wearable device traffic is expected to surpass 40 zettabytes by zettabyte equals 1 trillion gigabytes. And this big data explosion is just as apparent within clinical trials. Non-CRF (case report reform) data now represents 70% of clinical data and is growing at 40% per year.

The challenge isn’t having enough data, but to understand what is relevant and how to use it in a meaningful way.

Medical device research includes collecting data from the devices themselves, electronic data capture and companion devices, like fitness monitors. Halloran Consulting will present on how this trend presents an opportunity to learn from the early days of EDC in determining which data is meaningful and how to design trials and systems to leverage the availability of data instead of being overwhelmed by it.

Additionally, Chiltern/Covance will illustrate how data-driven decision-making solutions based on evolving technology are influencing strategies for managing risk, quality and performance management.

Featured Speakers:

Ms. Sapna Hornyak

Executive Vice President, Medical Device and Diagnostics

Ms. Sapna Hornyak has more than 18 years of clinical research experience including both site management as well as trial management in a broad range of therapeutic indications over the entire study lifecycle. Since joining the CRO industry in 2005, Sapna has focused almost exclusively on supporting medical device and diagnostic clients. As Executive Vice President in Chiltern’s Medical Device Business Unit, she has experience supporting clients ranging from small, virtual startup companies to market-leading global medical device companies on studies across all classes of medical devices as well as combination products.

Paola Murphy

Managing Director
Halloran Consulting Group

Paola Murphy has more than 20 years of clinical research experience mainly within the medical device industry spanning development thru commercialization activities including leading cross-functional process and systems initiatives. Currently as Managing Director at Halloran Consulting Group, Paola leads the Clinical, Safety, and Medical Affairs practice areas specializing in helping clients thru global change initiatives, value improvement projects, and in navigating complex compliance or regulatory challenges.


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