Patient Centricity in Clinical Trials with Craig Lipset
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More episodes from Clinical Trial Podcast | Conversations with Clinical Research Experts
Jan 18, 2023
Clinical Trial Site Networks with Christian Burns
There are advantages and disadvantages when it comes to being a standalone clinical trial site.
Standalone clinical trial sites enjoy the freedom of running their own operations. But they may face challenges with executing some parts of a clinical trial.
This is where site networks come in.
For example, a site can run more efficient marketing campaigns, be more systematic in its clinical trial operations, or share patient recruitment and retention resources by being part of a site network.
To learn more about site networks, I invited Christian Burns, President of Elligo Health Research and Co-Founder of ClinX, on the show.
Christian is a serial entrepreneur, investor, and founder of multiple clinical trial companies, including ClinEdge, BTC Network, and Guidestar Research.
Christian has a track record of success in the pharmaceutical industry, with a particular focus on decentralized and direct-to-patient clinical trials.
With experience across most therapeutic areas and a presence in over 30 languages and 40 countries, Christian's companies have served patients and providers across thousands of research sites globally.
His goal is to accelerate the development of new therapies by creating innovative solutions that connect and empower the clinical trial ecosystem.
A native of Philadelphia, Christian holds a B.A. in Public Health from the University of Tampa.
Enjoy!
Sponsors:
This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.
This podcast is brought to you by Slope. Slope’s eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit slope.io.
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Dec 29, 2022
Heart Failure Clinical Trials with Sonna Patel-Raman
In this episode, I’m excited for you to learn about Heart Failure Clinical Trials for medical devices.
Our guest today is Sonna Patel-Raman. Sonna is currently the President at NuPulse Inc, an early stage medical device company responsible for developing the first minimally invasive, long-term, ambulatory counterpulsation device that works in sync with the heart.
At NuPulse, Sonna is responsible for developing and executing on strategic initiatives for the company, building a diverse and multidisciplinary team of engineers, regulatory and quality associates, marketing, manufacturing, clinical affairs and education, and trial operations. Sonna and her team successfully completed enrollment in an FDA-approved feasibility trial and are now working towards the next phase of their medical product development lifecycle.
Sonna has extensive experience in the heart failure medical device space. Prior to joining NuPulse in 2015, she worked as the FDA Branch Chief where she managed a team of 16+ reviewers and clinicians and was responsible for the technical review and development of pre-marketing approvals (PMAs), Investigational Device Exemption (IDEs), 510k)s and more.
In this interview, Sonna provides us with a great introduction to heart failure trials, an overview of the medical device ecosystem for the treatment of heart failure, unique operational considerations for heart failure clinical trials, working as a woman leader in the medtech space, and more.
Sonna is an effective communicator (as you’ll soon find out after listening to this interview) and an amazing human being. I hope you enjoy my conversation with Sonna Patel-Raman.
Sponsors:
This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors - to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.
This podcast is brought to you by Slope. Slope’s eClinical Supply Chain Management (eCSCM) platform reduces clinical trial risks, reigns in costs, improves the productivity of clinical trial collaborators, and increases subject retention by removing the manual, spreadsheet-driven, and error-prone processes used to manage and track clinical supplies and biological samples to a digital platform. To learn more, visit slope.io.
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Dec 10, 2022
Medical Imaging for Clinical Trial Sites with Kelie Luby
To learn more about site reads and the role of medical imaging software, I invited Kelie Williams Luby, Vice President of Clinical Trials at Mint Medical.
Kelie has 24 years of experience as a clinical trial researcher, first as a medicinal chemist, and for the past 19 years as a clinical trialist in medical imaging-based endpoints. She is passionate about optimizing clinical trial designs while reducing the cognitive burden placed on healthcare providers treating patients in those clinical trials. Kelie believes it is possible to improve the efficiency of how clinical trials with imaging-based endpoints are conducted while also improving the reliability of data abstracted from participants during clinical trials. She holds a B.S and M.S in Chemistry along with a Master’s in Technical, Scientific, and Medical Communication.
Sponsor: This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/
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