Evidera

Articles

Key challenges and strategies to consider when developing devices intended for home-use or deployment in a clinical research setting. 

Addressing Challenges With Intelligent Point-of-Care Device Deployment

Technological innovations, market need, and evolving regulatory requirements have led to a rapid growth in Point of Care (POC) testing and devices. This webinar will help you understand the use of POC devices to support clinical research, learn key development and regulatory requirements for POC devices and use decentralized study models to support evidence generation for POC development.

http://www.appliedclinicaltrialsonline.com/act/poc

Technological innovations, market need, and evolving regulatory requirements has led to a rapid growth in Point of Care (POC) testing and devices. POC testing involves medical diagnostic tests performed outside a laboratory environment, and increasingly in the home setting. Home-use devices aid in the early detection of potential health conditions in the absence of symptoms, facilitate early and more optimal treatment interventions and reduce burden on healthcare systems. The evolution of home-use devices and changing regulatory landscape and evidence requirements presents challenges for clinical researchers that require innovative and robust operational and technical solutions.

Study models to support evidence generation for home-use device development

Technological approaches to integrating data from home-use devices to support clinical research

Key development and regulatory requirements for home-use devices

Pharmaceutical, biotechnology, medical device, and diagnostics companies - areas within companies: data analysis, health economics, outcomes research, medical affairs, clinical research, clinical trials, innovation, technology, project management, real-world evidence


MRes CBiol CSci MRSB, Executive Director, Peri- and Post-approval Studies
PPD


MS, Director, Regulatory Affairs, Medical Devices and Diagnostics
PPD


Senior Director, Data Architecture, Digital and Decentralized Solutions
PPD




MS, Business Optimization Lead, Executive Director, Project Delivery
PPD




Director, Non-Interventional Studies
PPD

Webcasts

Webinar Date/Time: Mon, Feb 13, 2023 10:00 AM EST


Addressing Operational and Technical Challenges in Home-use Point-of-Care Device Development and Deployment

Tokenization is becoming more popular with the increase in already tokenized real-world data sets and innovative methods for collecting data. This presentation aims to answer when, why and how patients are tokenized in these newer methods and what happens with the patients and their tokens.

https://globalmeet.webcasts.com/starthere.jsp?ei=1582141&tp_key=0213c1b8e0

The ability to link disparate datasets with de-identified or anonymized patient data has existed for decades but has been unrealistic to apply at scale. Tokenization is becoming more popular with the increase in already tokenized real-world data sets and innovative methods for collecting data. When, why, and how patients are tokenized in these newer methods and what happens with the patients and their tokens are still new to the industry. This presentation aims to answer those on-the-ground application questions.


What is tokenization and how does it benefit various stakeholders?

How are patients tokenized and what are some of the key considerations

Once patients are tokenized, what do you do with the token and are there other operational considerations?

VP and Global Head PPAS & RWE
Specialized Solutions
PPD

Mariah Baltezegar leads the Peri- and Post-Approval Studies (PPAS) and Real-World Evidence (RWE) Specialized Solutions team. As an executive member of the PPAS & RWE leadership team, she is responsible for direction of the PPAS & RWE innovation hub and new offering incubation as well as oversight of key operational, commercial and business optimization activities supporting the overall PPAS & RWE business unit. Over the last 20 years, she has held various positions of increasing responsibility across the Thermo Fisher (PPD) enterprise all with a strategic eye for efficiency through process or technology, maximizing the study participant and site experience while ensuring high quality customer results. Mariah completed her Master of Business Administration at the University of North Carolina, Wilmington and holds a bachelor's degree in psychology with a minor in statistics from Winona State University.


Senior Director, PPAS & RWE Non-
Interventional Studies
PPD

Christine Varner, BS, is a non-interventional studies lead on the Peri- and Post-Approval Studies (PPAS) and Real-World Evidence (RWE) team at Thermo Fisher (PPD). She is a member of the PPAS & RWE Senior Leadership Team, with overall accountability for the strategic talent growth strategy and operational performance of a team of Oversight Directors and Project Leads; drives leadership across performance in relation to financial stewardship, operational delivery and risk management, ensuring compliance with Thermo Fisher (PPD) process. Christine holds a bachelor’s degree in biology with a minor in chemistry from the University of North Carolina at Chapel Hill.


Tuesday, December 13, 2022 at 10am ET | 3pm GMT | 4pm CET


Webinar Date/Time: Tuesday, December 13, 2022 at 10am ET | 3pm GMT | 4pm CET


Evidera

Articles

Addressing Challenges With Intelligent Point-of-Care Device Deployment

Addressing Operational and Technical Challenges in Home-use Point-of-Care Device Development and Deployment

Tokenization: Practical Applications in Clinical and Real-World Research