How COVID-19 changed medical device clinical trials forever

The success of remote clinical trial oversight opens the door to hybrid approaches and creates new possibilities for the future of trials.

DeviceTalks

[Image from Unsplash]Because of the pandemic, virtually overnight, all players involved in medical device clinical trials had to pivot to virtual monitoring to keep trials going. What impact did remote trial oversight have on the quality, safety, and costs of clinical trials? What are the implications for the future?

A panel of experts from across the clinical trial ecosystem discussed these topics on a recent episode of DeviceTalks Tuesdays, sponsored by IMARC.

Panelists included Hamish Baird, clinical research president at Remington-Davis; Brandy Chittester, president of IMARC Research; Xavier Lefebvre, global VP of medical and regulatory operations at Medtronic; and Dr. Eric Kolodziej, corporate VP and global head of quality and regulatory affairs at Hologic.

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How COVID-19 changed medical device clinical trials forever

The success of remote clinical trial oversight opens the door to hybrid approaches and creates new possibilities for the future of trials.

[Image from Unsplash]

DeviceTalks

Because of the pandemic, virtually overnight, all players involved in medical device clinical trials had to pivot to virtual monitoring to keep trials going. What impact did remote trial oversight have on the quality, safety, and costs of clinical trials? What are the implications for the future?

A panel of experts from across the clinical trial ecosystem discussed these topics on a recent episode of DeviceTalks Tuesdays, sponsored by IMARC.

Panelists included Hamish Baird, clinical research president at Remington-Davis; Brandy Chittester, president of IMARC Research; Xavier Lefebvre, global VP of medical and regulatory operations at Medtronic; and Dr. Eric Kolodziej, corporate VP and global head of quality and regulator…

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Avania acquires IMARC

Avania today said it has acquired medical device clinical research IMARC for an undisclosed amount.

Strongsville, Ohio-based IMARC is a full-service clinical research oversight company that offers monitoring, auditing, safety, data management and training.

Get the full story on our sister site, Medical Design & Outsourcing.

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Avania acquires IMARC

Avania today said it has acquired medical device clinical research IMARC for an undisclosed amount.

Strongsville, Ohio-based IMARC is a full-service clinical research oversight company that offers monitoring, auditing, safety, data management and training.

“At Avania, we are focused on building a high-quality, full-service specialist medical technology CRO with global reach,” Avania CEO Sapna Hornyak said in a news release. “We are delighted to welcome the IMARC team, with whom we have had the pleasure of collaborating for some time. They bring a great commitment to client service and outcomes and allow us to offer our clients additional depth and strength in the United States, complementing our existing global operations perfectly.”

Through the deal, IMARC’s clients will gain access to Avania’s extended international footprint in the EU and Australia. Netherlands-based Avania will also provide its biostatistics, strategic consulting, regulat…

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How To Make Your Clinical Monitoring Efforts Matter

How should sponsors and sites define successful clinical monitoring today, and what can they do to ensure they achieve their goals?

By John Lehmann, Director of Business Development

Whether you’re performing it on-site or remotely, clinical monitoring comes with many challenges. In the past decade (and even the past year), monitoring has evolved.

How should sponsors and sites define successful monitoring today, and what can they do to ensure they achieve their goals? Here’s a closer look at what monitoring should accomplish and how to improve outcomes.

What Is Clinical Monitoring?

The FDA defines monitoring as the act of overseeing an investigation. The International Organization for Standardization elaborates further, explaining that the purpose is to ensure an investigation is “conducted, recorded, and reported in accordance with the clinical investigational plan (CIP), written procedures, the International Standard, and the applicable r…

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