Mobile Medical Devices

Mobile Medical Devices

By: Jonathan C. Young, PhD, MS, CIP, CCRP Senior Research Regulatory Operations Analyst Rush University Medical Center

Abstract: The use of mobile medical devices in clinical research is increasing significantly. This article provides an overview of regulations and guidance related to mobile medical devices including mobile apps. Possible risks and controversy that may arise from the use of mobile medical devices and how to improve submissions to institutional review boards for research involving mobile medical devices are also discussed. Examples of institutional review board review of real studies involving mobile medical devices at Rush University Medical Center are provided.

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Improving Communication in Clinical Research

Improving Communication in Clinical Research
By: Anatoly Gorkun, MD, PhD, Chartered MCIPD
            Senior Manager, Global Clinical Development, PPD UK

Abstract: Effective communication skills in clinical research are vitally important. Due to many conflicting priorities however, clinical research professionals may not have time to manage soft skills. This increases the danger that something may go wrong. This article highlights real-life clinical research examples where communication problems affected deliverables or compliance. The principles of effective communication styles are discussed.

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Clinical Research Studies During the COVID-19 Pandemic Public Health Emergency

Corona Virus Molecule Rendering Public Health Crisis

Defining a “New Normal” in Clinical Research to Support the World’s 336,747 Research Studies

By: Jennifer Goldfarb – MSN, RN, CCRP

As of April 21, 2020, according to clinicaltrials.gov, there were 336,747 research studies registered by organizations in all 50 states and 210 countries throughout the world. Clinical Research is a delicate ecosystem within healthcare that can be easily advocated for as an essential healthcare service. It is a highly complex, intensely regulated and regimented, environment. It is a critical component of healthcare that drives scientific and medical advances to promote health and treat illness. This environment has suffered unprecedented disruption and chaos during this pandemic. While people hunker down in their homes, waiting for this storm to pass, clinical research conduct is being adapted, paused, and even discontinued, in every therapeutic area.

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Digital Tools for Billing Compliance

By: Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC
Kelly Willenberg & Associates

Abstract: Mobile technology, social media, and health information technology can help clinical research sites handle billing compliance. This article describes digital tools that clinical research professionals already have that they can use to facilitate billing compliance as well as the benefits and challenges of each tool. Clinical research professionals must determine which tools will be most effective at their site.

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Human Factors Testing and Clinical Research

Tim Reeves, CHFP
Founder and Managing Director
Human Factors MD

Abstract: Human factors simulated-use studies provide a valuable tool for evaluating the usability and safety of medical devices, including combination products such as inhalers, injection devices, and transdermal patches. Through human factors studies, researchers evaluate how users and devices perform in low-frequency high-risk situations that may not occur in controlled clinical trials. This article provides an overview of the role of human factors testing in combination product development as well as how human factors studies complement traditional clinical trials in establishing safety and efficiency in drugs and devices.

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FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes

FDA Drug Approval Process

U.S. Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA).
As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more collaborative approach to our drug approval process. Today, drugs that are approved by the FDA to be marketed in the United States are developed both in and out of the United States.

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