It didn’t all change in March 2020. Not really. The UK high street has been in the throes of a gradual revolution for decades. From the rise of ecommerce, to the birth of mobile, social commerce, and a growing emphasis on experience, change has been underway for a while. In fact for many, the pandemic has acted as a wake-up call. Digital transformation was no longer a ‘nice to have’ but a matter of survival. Necessity sparked innovation and customers are enjoying more flexibility and conveni ...
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continue reading
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Strategy & Tactics for Combination Device Clinical Trials – MedTech CRO: Strategy Development Series
Manage episode 428396376 series 2688337
Content provided by RQM+. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by RQM+ or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
Combination Device Clinical Trials: Strategy & Tactics
Join RQM+ experts Jaishankar Kutty, PhD and Chad Quistad as they unpack the complexities of combination device clinical trials in this comprehensive educational video.
Key topics covered:
- Definition and examples of combination devices
- Regulatory pathways in the US and EU
- Product development challenges unique to combination products
- Essential documentation for robust trial design
- Critical considerations for successful trial execution
Highlights include:
- The importance of cross-functional expertise in drug and device development
- Crucial pre-trial steps: usability studies, risk analysis, and early stability testing
- Strategies for overcoming common trial execution challenges
- Real-world case study demonstrating the value of proactive testing
Whether you're new to combination devices or looking to optimize your approach, this video offers valuable insights to enhance your clinical trial strategy.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
📧 For support with clinical trials, please contact us directly.
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📲 Follow RQM+ on LinkedIn.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
153 episodes
Strategy & Tactics for Combination Device Clinical Trials – MedTech CRO: Strategy Development Series
Share
Manage episode 428396376 series 2688337
Content provided by RQM+. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by RQM+ or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
Combination Device Clinical Trials: Strategy & Tactics
Join RQM+ experts Jaishankar Kutty, PhD and Chad Quistad as they unpack the complexities of combination device clinical trials in this comprehensive educational video.
Key topics covered:
- Definition and examples of combination devices
- Regulatory pathways in the US and EU
- Product development challenges unique to combination products
- Essential documentation for robust trial design
- Critical considerations for successful trial execution
Highlights include:
- The importance of cross-functional expertise in drug and device development
- Crucial pre-trial steps: usability studies, risk analysis, and early stability testing
- Strategies for overcoming common trial execution challenges
- Real-world case study demonstrating the value of proactive testing
Whether you're new to combination devices or looking to optimize your approach, this video offers valuable insights to enhance your clinical trial strategy.
Reminder that you can find all of our clinical trial videos in other places, too. 👇
📧 For support with clinical trials, please contact us directly.
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📲 Follow RQM+ on LinkedIn.
📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
153 episodes
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Similar to Device Advice by RQM+
It didn’t all change in March 2020. Not really. The UK high street has been in the throes of a gradual revolution for decades. From the rise of ecommerce, to the birth of mobile, social commerce, and a growing emphasis on experience, change has been underway for a while. In fact for many, the pandemic has acted as a wake-up call. Digital transformation was no longer a ‘nice to have’ but a matter of survival. Necessity sparked innovation and customers are enjoying more flexibility and conveni ...
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continue reading
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The traditional enterprise go-to-market motion is undergoing a transformational shift. B2B buyers are more sophisticated than ever, and operational efficiency is a key focus for every organization. One key function possesses a unique opportunity to shape the future of revenue generation: enablement. On this podcast, we’re bringing you the secrets, strategies, and tactics that successful enablement leaders are using to drive meaningful impact. The Enablement Edge is the go-to resource for sal ...
…
continue reading
Evan Davis hosts the business conversation show with insights from the people at the top.
…
continue reading
The Village Global podcast takes you inside the world of venture capital and technology, featuring enlightening interviews with entrepreneurs, investors and tech industry leaders. Learn more at www.villageglobal.vc.
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continue reading
Outsource Acelerator Podcast, hosted by Derek Gallimore, explores business and outsourcing mastery. Inside-knowledge from the outsourcing capital of the world - Manila, Philippines.
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continue reading
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Custom Manufacturing Industry podcast is an entrepreneurship and motivational podcast on all platforms, hosted by Aaron Clippinger. Being CEO of multiple companies including the signage industry and the software industry, Aaron has over 20 years of consulting and business management. His software has grown internationally and with over a billion dollars annually going through the software. Using his Accounting degree, Aaron will be talking about his organizational ways to get things done. Hi ...
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Big tech is transforming every aspect of our world. But how, and at what cost? This season of Land of the Giants – The Disney Dilemma – focuses on Disney’s ability to weather the ups and downs of the business cycle and changing tastes and explores what has kept it successful for over 100 years. The entertainment giant has leveraged nostalgia and its intellectual property to build a beloved brand, but after an acquisition spree that included Marvel, Lucasfilm, and 20th Century Fox, can it sus ...
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