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Note to File: A Clinical Research Podcast
Alle als (un)gespielt markieren ...
Manage series 2972247
Inhalt bereitgestellt von Brad Hightower. Alle Podcast-Inhalte, einschließlich Episoden, Grafiken und Podcast-Beschreibungen, werden direkt von Brad Hightower oder seinem Podcast-Plattformpartner hochgeladen und bereitgestellt. Wenn Sie glauben, dass jemand Ihr urheberrechtlich geschütztes Werk ohne Ihre Erlaubnis nutzt, können Sie dem hier beschriebenen Verfahren folgen https://de.player.fm/legal.
Note to File is a podcast for clinical research sites - interviews, best practices, and candid commentary from Brad Hightower, founder of Hightower Clinical and clinical research professional.
…
continue reading
100 Episoden
Alle als (un)gespielt markieren ...
Manage series 2972247
Inhalt bereitgestellt von Brad Hightower. Alle Podcast-Inhalte, einschließlich Episoden, Grafiken und Podcast-Beschreibungen, werden direkt von Brad Hightower oder seinem Podcast-Plattformpartner hochgeladen und bereitgestellt. Wenn Sie glauben, dass jemand Ihr urheberrechtlich geschütztes Werk ohne Ihre Erlaubnis nutzt, können Sie dem hier beschriebenen Verfahren folgen https://de.player.fm/legal.
Note to File is a podcast for clinical research sites - interviews, best practices, and candid commentary from Brad Hightower, founder of Hightower Clinical and clinical research professional.
…
continue reading
100 Episoden
Alle Folgen
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Note to File: A Clinical Research Podcast

In this episode we sit down with healthcare veteran Matthew Holt, founder of The Health Care Blog and Health 2.0. Matthew shares his fascinating journey from Stanford grad student to healthcare technology commentator, offering candid insights into digital health, clinical trials, and the challenges of healthcare innovation. From discussing the potential of GLP-1 drugs to exploring the future of longevity research, this conversation provides a witty and insightful look at the evolving landscape of healthcare technology and research.…
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Note to File: A Clinical Research Podcast

In this episode of Note to File, we dive deep into the world of clinical research, exploring the challenges of resident physician training, the impact of private equity on clinical trial management systems, and the often-unspoken ethical dilemmas in the field. Join us as we unpack difficult sponsor behaviors, share hilarious research confessions, and offer candid insights into the clinical research landscape. From PE investments to research sins, this episode is packed with humor, honesty, and hard-hitting discussions that will keep you entertained and informed.…
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Note to File: A Clinical Research Podcast

Special Pope election edition. In this episode, Rohit Nambisan from Lokavant and Jonathan Crowther from Pfizer discuss their innovative approach to clinical trial forecasting. They explore how advanced data analytics and AI can help predict and improve trial operational success, from site selection to protocol design. The conversation delves into reducing uncertainty, enhancing communication between sponsors and sites, and leveraging technology to make clinical research more efficient and patient-focused.…
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Note to File: A Clinical Research Podcast

1 CROs are Broken: Fixing Clinical Trials from the Inside Out with Meri Beckwith - Lindus Health 50:03
In this episode, Meri Beckwith from Lindus Health discusses his journey from venture capital to clinical research, sharing insights on the inefficiencies of traditional CROs. He explains how Lindus is taking a different approach by aligning incentives, focusing on patient experience, and developing innovative trial models. The conversation explores the challenges in clinical trials, from data collection to site management, offering a fresh perspective on how the industry might evolve.…
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Note to File: A Clinical Research Podcast

In this episode of Sticky Notes, Brad & Denali dive into the latest trends in clinical research, exploring how younger adults are getting medical advice from social media, the potential impact of pharmaceutical tariffs on R&D, and the evolving landscape of decentralized clinical trials. We discuss the challenges and opportunities of involving healthcare providers in clinical research, and touch on recent layoffs in the CRO industry. Join us for an insightful and candid conversation about the current state of clinical trials and occasional debates about cookies.…
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Note to File: A Clinical Research Podcast

We sit down with Bree Burks from Veeva to discuss the company's latest innovations in clinical research technology. We dive deep into Veeva's upcoming CTMS (Clinical Trial Management System), their strategy for connecting sponsors and sites, and the importance of creating more streamlined, user-friendly technology for clinical research sites. Bree shares insights from her nursing background and Veeva's mission to simplify technology for sites, making clinical trials more efficient and patient-focused.…
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Note to File: A Clinical Research Podcast

In this episode, Brad and Denali dive into recent industry developments, including Bay Pine's $1.5 billion acquisition of CenExel clinical research site network, the FDA's potential shift to AI-based animal testing alternatives, growing challenges with clinical trial recruitment and public trust, emerging pharmaceutical import tariffs, and the ongoing wave of layoffs in the life sciences sector. The discussion offers candid insights into the evolving landscape of clinical research, technology, and market dynamics.…
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Note to File: A Clinical Research Podcast

In this episode Jim Kremidas, Executive Director of the Association of Multi-Site Research Corporations (AMRC), discusses the evolving landscape of clinical research sites. We explore how multi-site research corporations are working to improve operational efficiency, quality standards, and patient experiences in clinical trials. Kremidas shares insights from his extensive background in pharmaceutical research highlighting the potential benefits of site network consolidation and standardization.…
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Note to File: A Clinical Research Podcast

1 From The Archives: Jamie Massengill - SSM Health 1:02:43
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In this episode, we sit down with Jamie Massengill from SSM Health to unpack the complex world of clinical research in community healthcare. We dive deep into the challenges of launching successful research programs, exploring innovative partnership models, physician engagement strategies, and how community hospitals can transform clinical trials. Learn how breaking traditional barriers can create meaningful research opportunities that benefit patients, physicians, and healthcare systems alike. Originally recorded in April 2022.…
In this episode we talk with Chris Venezia, CEO of ProofPilot, about the often-overlooked operational challenges in clinical trials. Chris shares his unexpected journey into clinical research and reveals how ProofPilot is transforming the industry by simplifying communication, document sharing, and patient engagement. From addressing fundamental communication gaps to exploring innovative solutions, this conversation offers a refreshing look at making clinical trials more efficient and user-friendly.…
We talk to Science 37 CEO Tyler Van Horn and discuss the past, present and future of the company - everything you wanted to know about Science 37 but were afraid to ask.
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Note to File: A Clinical Research Podcast

This episode is dedicated to feedback about the recent Save Our Sites (SOS) conference in Oklahoma City. The founders, Judy Galindo, Ashley Margot, Chris Sauber, Monica Cultiva and Dan Sfera join as we take live feedback from the livestream audience.
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Note to File: A Clinical Research Podcast

A short recap of recent news, events, social media posts, gossip, announcements, and anything else in the clinical research space. In this episode Paul Ivsin joins to talk Science 37 v Science 38, PEs buyout of Walgreens and CRA/CRC relationships.
Today we discuss vendor relationships , representation & its impact on business, diagnosis & after care - the main unmet need within pharma - and embroidery throwing.
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Note to File: A Clinical Research Podcast

In this episode Dan Sfera joins us to cover the somewhat puzzling creation of the Association for Multisite Corporations (AMRC), a big time data breach from DM Clinical Research, and why everything in clinical research is an emergency.
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Note to File: A Clinical Research Podcast

In this episode we discuss the challenges and perceptions of central recruitment campaigns, including resistance from sites, the need for a thoughtful, patient-centered approaches rather than a boiler room approach and Paul helps to dispell a few clinical trial myths.
Kerri Weingard is a founding partner and global chief operating officer at Verified Clinical Trials (VCT). VCT is the largest global research subject database to reduce dual enrollment and prevent protocol violations. Ms. Weingard is also the CEO and founder of Study Scavenger and Clinical Hero. Both companies are dedicated to clinical trial recruitment and education. Ms. Weingard, who is a nurse practitioner, holds a master’s degree in science from Stony Brook University. She, before creating VCT and Study Scavenger, has conducted over 500 clinical trials as a research administrator and sub-investigator. She has more than two decades of experience in the field and is a member of a number of professional organizations, including the American Society for Clinical Pharmacology and Therapeutics, the Drug Information Association and the Association of Clinical Research Professionals.…
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Note to File: A Clinical Research Podcast

Ignacio Handal is the CEO at Clinicom Healthcare. Ignacio has completed a multitude of FDA phase I, II, & III studies in pharmaceuticals, and devices over two decades. In 2022 Ignacio was honored with one of the highest honors in Clinical Research, the Christine Pierre Clinical trials lifetime achievement award of which only 8 clinical researchers globally have ever been awarded. Early in his career Ignacio, Co-Founded the 5th leading private CNS research site in the US called Harmonex Neuroscience research in 2003 that continues excelling to this day. Ignacio and his team have used 100% of the profits of their research trials over the last twenty years to develop the world's first online mental health assessment software that can assess anyone remotely for 81 mental health conditions in one virtual adaptive ML assessment. Clinicom has helped patients all over the world find answers on their mental health journey. Clinicom has also helped accelerate enrollment and patient identification for precise inclusion and exclusion criteria in 70 phase II and III studies in the US. The Clinicom mission is to give every patient a voice and to bring equity and access to mental health. Clinicom currently serves patients on 6 continents. This week we discuss how to improve site selection, the challenges of vendor selection, and how Clinicom was born from a site. Ignacio Handal on LinkedIn: https://www.linkedin.com/in/iggyhandal/ Clinicom on the web: www.clinicom.com/overview Learn more about our sponsor, Veeva Vault: http://sites.veeva.com Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY…
Thomas Peterson has been in healthcare for approximately 17 years now. A vast majority of that experience is in clinical research. He has served in many capacities such as a Research Assistant, Study Coordinator, Senior Study Coordinator, Clinical Research Associate and now Senior Clinical Research Associate. He founded his own consulting company to assist anyone in the clinical research space that needs guidance. Thomas works within the oncology, neuro-oncology, rare disease, infectious disease spaces as well as pediatrics. This week we discuss the shift from CRC to CRA, humanity in clinical trials, the downstream effects of “innovation” in the industry and so much more. Thomas Peterson in LinkedIn: http://www.linkedin.com/in/thomas-peterson-6173a7228 Peterson Research: www.peterson-research.com Learn more about our sponsor, Veeva Vault: http://sites.veeva.com Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY…
Jason Palasota had always been passionate about improving the quality of clinical research services delivered to patients. He first got his feet wet working on the ground level as a site coordinator for Cetero Research, formerly known as Diabetes and Glandular Research. From there, he began to develop an even deeper respect for the industry and continued to pursue opportunities that would allow him to drive change. After working on the ground level, he was inspired to make an impact and improve the quality of clinical research services delivered to patients. Determined to bring about positive change, Jason worked his way up from proposal development and inside sales roles to external business development positions at Worldwide Clinical Trials, ResearchPoint Global, and IQVIA (formally Quintiles). As Jason gained more experience in this field, he became increasingly aware of significant relationship and communication gaps that existed within the industry. He was determined to bridge these gaps by forming strong partnerships between exceptional clinical research sites and innovative sponsors/CROs. His goal was simple: make a positive difference in people’s lives through top-tier healthcare solutions around the world. Clinitiative Health Research was born. This week we discuss the various business development models for sites, why sites might want to consider partnering with a business development vendor, and the incredible significance of relationships in clinical research. Clinitiative Health Research on Linkedin: https://www.linkedin.com/company/clinitiative/ Clinitiative Health Research on Twitter: https://twitter.com/ClinitiativeHR , Clinitiative Health Research on Facebook: https://www.facebook.com/ClinitiativeHealthResearch Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY…
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Note to File: A Clinical Research Podcast

Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Rohit was most recently the Head of Digital Product at Roivant and the Head of Product at Prognos Health. Rohit holds an M.S in Management and Engineering from MIT, an M.A. in Neuroscience from Boston University, and a B.A in Cognitive Neuroscience from UC Berkeley. In this episode we discuss fragmentation amongst study stakeholders, the importance of real time data that’s agnostic to source, and the impact of decentralized clinical trials and an increase in disparate data sources. Rohit Nabisan on LinkedIn: https://www.linkedin.com/in/rohitnambisan/ Lokavant website: https://www.lokavant.com/ Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY…
Brittany Sloan is the Director of Black Research Matters, a safe space exclusively for Black people to learn more about research with the purposes of being becoming better-informed decision-makers thus strengthening the community by using knowledge as a tool to navigate the medical and healthcare systems. This episode is the conclusion of a 3 part series on the Tuskegee Syphilis Experiments presented by Brittany. Brittany Sloan on LinkedIn: https://www.linkedin.com/in/whitney-stewart-b9969326/ Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY…
Whitney Stewart is the director of clinical project management at Curebase. She has served the clinical research space for more than 10 years, and holds bachelors' degrees in Molecular and Cellular biology, and Italian Studies. In this episode we discuss evidence standards for digital therapeutics and the recent Digital Therapeutics Alliance publication “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard”. Whitney on LinkedIn: https://www.linkedin.com/in/whitney-stewart-b9969326/ Digital Therapeutics Alliance and Curebase release publication setting the stage for a fit-for-purpose evidence standard for digital therapeutics (DTx): https://www.curebase.com/news/digital-therapeutics-alliance-and-curebase-release-publication-setting-the-stage-for-a-fit-for-purpose-evidence-standard-for-digital-therapeutics-dtx Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY…
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Note to File: A Clinical Research Podcast

Amanda Santimaw is the Director of Clinical Research for the 9 locations of Arizona Arthritis & Rheumatology, plus 4 external physician locations. She is responsible for the oversight of over 180 current clinical trials, 17 Principal Investigators, 24 dedicated research staff working in rheumatology, gastroenterology, endocrinology, and internal medicine. She has 15 years of experience working in Phase I-IV clinical trials, observational studies, and retrospective data analysis. Amanda received both her Bachelors of Science and Masters of Science in Clinical Research Management from Arizona State University. When Amanda is not at work, she enjoys spending time with her husband, daughter and new baby, going hiking, camping, and traveling Rebecca Martinez is the Operations Manager of Clinical Research and is Amanda’s co-pilot for all the locations. She has over 10 years’ experience in the clinical research field in rheumatology and gastroenterology. She is responsible for the successful study start-up, recruitment, and maintenance for all the ongoing trials. She too received her masters of science in clinical research management from ASU. This week we discuss the challenges of managing site level documents, making the jump to electronic regulatory with Veeva, CTMS, eSource and so much more.…
Wayne Walker is Senior Vice President, Product for Rave Platform Technology (including Rave EDC, Rave RTSM, Rave Imaging, Rave Coder, and Rave Safety Gateway) at Medidata. His responsibilities include the strategy, development, and delivery of these products across all Research & Development disciplines. Before joining Medidata, Wayne spent 12 years overseeing Product Management for clinical technology used by Data Management and Biometrics at PRA Health Sciences. This involved oversight of Platform as a Service, Software as a Service, on-premise deployed environments, and in-house developed solutions This week we discuss the vendor/site relationships, why there is a proliferation of disparate systems, the potential of direct to EDC data entry and so much more.…
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Note to File: A Clinical Research Podcast

Charles Fisher is the founder of Unlearn which is using AI to simulate potential health outcomes for individual patients. Charles is a scientist with interests at the intersection of physics, machine learning, and computational biology. Previously, Charles worked as a machine learning engineer at Leap Motion and a computational biologist at Pfizer. He was a Philippe Meyer Fellow in theoretical physics at École Normale Supérieure in Paris, France, and a postdoctoral scientist in biophys.ics at Boston University. Charles holds a Ph.D. in biophysics from Harvard University and a B.S. in biophysics from the University of Michigan. This week we discuss digital twins, the impact of AI on clinical trials, clinical trial data ownership and much more…
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Note to File: A Clinical Research Podcast

Amy is a leader with experience in clinical trial program operations and regulatory compliance. As a results-driven professional, she has a proven ability to oversee program processes, project management, quality improvement, and timely execution of clinical trials. Knowledgeable in academic and large healthcare settings, as well as public health and private physician practices. Her areas of expertise focus on early phase human pharmaceutical clinical research in the specialties of pediatrics, oncology, neurology, cardiology, infectious disease, dermatology, and diabetes. This week we discuss the increasing complexity of clinical trials operations, connecting SOPs to processes and the difference between QC and QA.…
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Note to File: A Clinical Research Podcast

Dan Otap is a Principal Alliance & Partnerships Lead within Genentech’s Research and Early Development unit (gRED). Dan’s clinical trial operations and compliance background uniquely position him to provide attuned insight into relational site engagement. Dan serves on various internal Roche/Genentech work streams related to clinical trial execution and innovation. He holds positions with the Association of American Cancer Institute (AACI) as well as the Society of Clinical Research Sites (SCRS). Dan has presented at various clinical research conferences and has authored multiple peer reviewed publications spanning clinical trial topics ranging from Community Oncology Practices, to overall site/sponsor relationships. Prior to his arrival at Genentech, Dan established his career in oncology clinical trials at various world-leading institutions. His first position was a Research Study Assistant within the Department of Neurology at Memorial Sloan Kettering Cancer Center (MSKCC). In 2011, Dan was recruited to Columbia University Medical Center to become the Clinical Research Manager within the Department of Neurology, Division of Neuro-Oncology. In 2012, he took on a dual appointment between the CUMC Department of Neurology and the Clinical Research Management Office (CRMO) within the Herbert Irving Comprehensive Cancer Center (HICCC). He was instrumental in the creation of an internal QA/Monitoring Division within the Cancer Center.. He subsequently was appointed as the Associate Director, Regulatory Affairs within HICCC, and oversaw all regulatory submission processes, compliance/monitoring/auditing activities, DSMC/PRMC managers, Multi-Site Operations, and IND Office processes, which assisted clinical investigators with correspondence with the FDA. His last site based position was at City of Hope Comprehensive Cancer Center in Pasadena, CA. where he served as the Executive Director of Community & Affiliate Practices, focusing on development of clinical trial infrastructure across 30+ satellite locations across southern California.…
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Note to File: A Clinical Research Podcast

Ethan Seville is a clinical research professional who has worked in a wide range of indications across various roles such as patient recruitment, coordinating, quality assurance, management, and regulatory. Ethan is now the Manger of Customer Engagement and Strategic Solutions for Slope.io, which helps researchers by ensuring their network of clinical trial patients get the exact medical supplies their care requires on time, on schedule and on budget. In this episode, Ethan interviews me 😳.…
Kate is the founder and Chief Executive Officer of Innovative Trials, a global patient recruitment organization. Kate has over 20 years of experience in the pharmaceutical and patient recruitment industry while working in clinical operations and patient recruitment positions. Kate is a vocal advocate for equality, diversity and inclusion in clinical research as well as for meaningful community engagement that puts patients and sites at the heart of the clinical research. This week we discuss awareness vs education, the challenges of physician referrals and the importance of real community outreach.…
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