Shows
Note to File: A Clinical Research PodcastAI, Ethics & Cookies: Clinical Research Trends with Dan SchellJoin Brad, Denali, and guest Dan Schell from Clinical Leader for a lively and insightful conversation on the latest trends in clinical research. From the real-world impact of AI and the evolution of site networks to the challenges of technology adoption and industry ethics, this episode dives deep into what’s shaping the future of clinical trials. Plus, enjoy some lighthearted banter about cookies and the quirks of the industry. Whether you’re a research professional or just curious about the field, this episode offers valuable perspectives and a few laughs along the way!2025-07-0755 minNote to File: A Clinical Research PodcastDigital Health, Clinical Trials, and Beyond with Matthew Holt - The Health Care BlogIn 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.2025-05-1654 min
Note to File: A Clinical Research PodcastClinical Research Confessions: PE, Trials, and Research SinsIn 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.2025-05-1430 minNote to File: A Clinical Research PodcastClinical Trials 2.0: AI, Predictions, and the Future of Research with LokavantSpecial 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.2025-05-0948 minNote to File: A Clinical Research PodcastCROs are Broken: Fixing Clinical Trials from the Inside Out with Meri Beckwith - Lindus HealthIn 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.2025-05-0850 min
Note to File: A Clinical Research PodcastSticky Notes 4/30/25In 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.2025-05-0535 minNote to File: A Clinical Research PodcastBree Burks - VeevaWe 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.2025-04-2845 min
Note to File: A Clinical Research PodcastSticky Notes 4/15/2025In 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.2025-04-2130 minNote to File: A Clinical Research PodcastJim Kremidas - AMRCIn 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.2025-04-1452 min
Note to File: A Clinical Research PodcastFrom The Archives: Jamie Massengill - SSM HealthIn 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 2022.2025-04-071h 02Note to File: A Clinical Research PodcastChris Venezia - ProofPilotIn 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.2025-03-3150 minNote to File: A Clinical Research PodcastTyler Van Horn - Science 37We 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.2025-03-2555 min
Note to File: A Clinical Research PodcastSticky Notes 3/19/2025This 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.2025-03-2454 min
Note to File: A Clinical Research PodcastSticky Notes 3/12/2025A 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.2025-03-1731 minNote to File: A Clinical Research PodcastDenise Bronner PhD - Empactful VenturesToday we discuss vendor relationships , representation & its impact on business, diagnosis & after care - the main unmet need within pharma - and embroidery throwing.2025-03-1053 min
Note to File: A Clinical Research PodcastSticky Notes 2/26/2025In 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.2025-03-0326 minNote to File: A Clinical Research PodcastPaul IvsinIn 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.2025-02-1353 min
Note to File: A Clinical Research PodcastKerri Weingard, Verified Clinical Trials 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 ex...2023-11-3044 min
Note to File: A Clinical Research PodcastIgnacio Handal, ClinicomIgnacio 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...2023-07-0638 min
Note to File: A Clinical Research PodcastThomas Peterson, Peterson Research Consulting 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 i...2023-06-1451 min
Note to File: A Clinical Research PodcastJason Palasota, Clinitiative Health Research 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...2023-05-3149 min
Note to File: A Clinical Research PodcastRohit Nambisan, Lokavant 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...2023-05-2444 min
Note to File: A Clinical Research PodcastBrittany Sloan, Tuskegee Syphilis Study - Part 3Brittany 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/41YxjXY2023-05-1521 min
Note to File: A Clinical Research PodcastWhitney Stewart, CurebaseWhitney 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/digit...2023-05-1137 min
Note to File: A Clinical Research PodcastAmanda Santimaw and Rebecca Martinez, Arizona Arthritis & Rheumatology 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...2023-04-2642 min
Note to File: A Clinical Research PodcastWayne Walker, Medidata SolutionsWayne 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...2023-04-1942 min
Note to File: A Clinical Research PodcastCharles Fisher, UnlearnCharles 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 Univ...2023-04-0639 min
Note to File: A Clinical Research PodcastAmy FoxAmy 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...2023-03-2246 min
Note to File: A Clinical Research PodcastDan OtapDan 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...2023-03-1548 min
Note to File: A Clinical Research PodcastEthan Seville, Slope.ioEthan 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 😳.2023-03-0153 min
Note to File: A Clinical Research Podcastthis message will self destructsecret communique www.saveoursites.com 2023-02-2302 min
Note to File: A Clinical Research PodcastKate Shaw, Innovative TrialsKate 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.2023-02-2241 min
Note to File: A Clinical Research PodcastScott Stout, MedVectorScott Stout has been recognized as one of the top healthcare innovators of 2021. While working as a professional investor in high-finance, Scott identified a large gap in the clinical trial marketplace and seized the opportunity to build a team of healthcare, high tech, and venture capitalists to turn his concept of expanding clinical trials, “Beyond Clinical Trial Sites,” into a reality. Prior to founding MedVector, Scott worked with notable companies such as Morgan Stanley and Wells Fargo Private Bank. His entrepreneurial spirit has driven him to help numerous start-ups develop their market-fit, revenue models, capital raises, and go-to-market strategies. ...2023-02-1543 min
Note to File: A Clinical Research PodcastJennifer Bonfrisco, Corlexia Clinical Services Jennifer Bonfrisco has spent over 30 years working in R & D for Pharma, CROs, and Academia. She began her career in preclinical pharm/tox, transitioned to clinical research, and has never looked back. Over the years, some things have changed, but slow patient enrollment and barriers to participation have stayed static. Trial accessibility was the spark that led Jennifer to create Corlexia Clinical Services. Jennifer spent years finding ways to make trials more patient and doctor-friendly, leading her to create a company dedicated to building customized trial solutions resulting in reaching more medical practices, patients, and families. ...2023-02-0846 min
Note to File: A Clinical Research PodcastMitchell Hilbe, Kenzona Clinical ResearchMitchell Hilbe has been involved in clinical research since high school as he was introduced to the industry at a very young age. He carved his own path as a paramedic and EMS instructor for several years before jumping back into clinical research around 8 years ago as a CRA. Mitch is currently working as a Sr. CRA as well as recently co-founding Kenzona Clinical Research earlier this year. Kenzona is a designed as a scalable SMO using Veeva SiteVault. Mitch also founded the Clinical Research Justice League to advocate for better equality and ethics in the clinical trial community....2023-02-0142 min
Note to File: A Clinical Research PodcastSteve Rosenberg, uMotifSteve Rosenberg's career in life science and healthcare spans more than 40 years. He has led the development and deployment of cloud-based solutions with a focus on driving more integrated approaches to patient-centric trial management. Steve was most recently Senior Vice President and General Manager of Oracle Health Sciences. Prior to that he was the visionary behind the integrated clinical technology suite introduced by Phase Forward which was acquired by Oracle in 2010. Steve joined uMotif’s board earlier this year. In his spare time, Steve enjoys summers on Cape Cod with his family. Steve also sits on t...2023-01-2548 min
Note to File: A Clinical Research PodcastDr Michael Koren, ENCORE Research GroupMichael J. Koren, MD, is a practicing cardiologist and Chief Executive Officer at Jacksonville Center for Clinical Research, which conducts clinical trials at 7 locations in Florida. He received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine and fellowship in cardiology at New York Hospital/Memorial Sloan-Kettering Cancer Center/Cornell Medical Center. He is a fellow of the American College of Cardiology, fellow and two-time president of the Academy of Physicians in Clinical Research, and the regional chapter of the American Heart Association. Dr. Koren has served as...2023-01-1831 min
Bite the Orange14. Brad Hightower - Increasing access for everyone to new treatment options through clinical trial participationThere are still great barriers to participating in clinical trials, which need to be brought down!
In this episode of Bite the Orange, we have Brad Hightower, CEO of Hightower Clinical, a company focused on increasing access to clinical trials by creating community partnerships and reaching out to physicians, hospitals, and medical groups to offer no-cost research infrastructure. Brad talks about his mission and how Hightower Clinical works with enrolled patients, ensuring they are informed about all the risks and benefits of participating in a clinical trial. Challenges like overestimations of patients in sites, qualifications, diversity, and...2023-01-1025 min
Note to File: A Clinical Research PodcastGunnar Esiason, Florence HealthcareGunnar Esiason is a cystic fibrosis and rare disease patient leader, who is passionate about early-stage drug development, patient empowerment and health policy. Professionally, he developed a patient engagement platform for a medical nutrition company, built a venture philanthropy practice at the Boomer Esiason Foundation and was the head coach of his high school alma mater’s varsity hockey team. He has consulted on clinical trial development, a real-world evidence population health study, and a cystic fibrosis-specific mental health and wellness screening tool. Gunnar has been the face of fundraising efforts for the Boomer Esiason Foundation, which has yielded mo...2023-01-1043 min
Note to File: A Clinical Research PodcastShawn Blackburn, YPrimeAs CEO of YPrime, Shawn Blackburn provides strategic leadership and direction. Since co-founding YPrime in 2006, Shawn has led the company growth from a two-person consulting firm to a global organization that focuses on evolving technologies to help accelerate development timelines, simplify process complexity, and improve data quality across the clinical development continuum. With a background in systems architecture and information management, Shawn has built a reputation for helping companies discover insights about future opportunities by bringing together siloed information in meaningful context to support strategic decision making. Prior to YPrime, Shawn had a long career as a...2023-01-0346 min
Note to File: A Clinical Research PodcastMichelle Shogren, Innovate In What You Do! LLCWith over 25 years in the Clinical Research field, Michelle has experienced the clinical trial journey from multiple perspectives: patient, caregiver, site, CRO, and Pharma. She has now launched her own company, Innovate In What You Do! LLC, to bring all these together to help others improve their way of working with the user voice included. As the industry works through the disruptive nature of flexible, device enabled, community focused trials, her years of experience bring value to the multiple players in this ecosystem. Michelle’s greatest passion, beyond adrenaline sports, is customer focused innovation and re...2022-12-0544 min
Note to File: A Clinical Research PodcastMike Wenger, VersaTrialMike Wenger is a software developer who has been building solutions for clinical research for 15 years. Mike worked at the Michael J. Fox Foundation for Parkinson's research connecting Parkinson's patients to clinical studies, built Citeline Connect to connect patient recruitment companies and pharma companies, and is now the founder and CEO of VersaTrial, a platform that reimagines the clinical trial site workflow. This week we discuss the chaos the clinical trial sites often deal with, how this chaos can impact research participants and how sites can stay better organized with a simple browser extension.2022-11-2348 min
Note to File: A Clinical Research PodcastSylvain Berthelot, CalyxSylvain Berthelot is the Senior Voice of Customer & Stratefy Director at Calyx, one of the leaders in eClinical and Regulatory technology. In his role, Sylvain aims to transform customer feedback into insights and decisions that will positively impact trial teams, sites and patients. Sylvain has assumed various roles during his 12+ years at Calyx, and he consistently kept his focus on reducing burden for sites and patients. He is the host of the podcast Calyx Café, where industry experts talk about clinical research trends, futurology, and best practices to reliably solve the complex in clinical trials T...2022-11-1640 min
Note to File: A Clinical Research PodcastArchana SahArchana Sah is a clinical development thought leader with extensive (30 years) experience and passion for developing medicines for patients having led and contributed to 15 FDA/EMEA drug approvals in Oncology, Immuno-Oncology, Precision Therapeutics, Rare Diseases, Metabolic Diseases and Women's Health. She has held various global positions within biotech and pharma including Genentech/Roche, Bayer Oncology, Johnson & Johnson, ICON, two Oncology biotech start ups and a Digital tech company Medable where she led Oncology TA Solutions. She is now the Founder and CEO of AS Pharma Advisors and provides strategic advisory services to several organizations in clinical development and operations...2022-11-0951 min
Note to File: A Clinical Research PodcastDr Leigh MackDr. Leigh J. Mack, was clinically trained in trauma and plastic surgery and is boarded as clinical research physician. He has designed many trials in the areas of pulmonary devices, aesthetic medicine (injectables), infectious disease nano-particles, medical lasers and other devices. He was recently a physician advisor to a 20-hospital healthcare system in utilization review and appeals. He has designed an automated software system for participant recruitment that employs RPA to search 100,000s of EMR records in a few days time to meet potential participants for clinical trials. In 2021, he left the position of Chief Medical officer for Crucial Da...2022-11-0750 min
Note to File: A Clinical Research PodcastDr David Grew, PRIMRDavid Grew is a practicing radiation oncologist and the founder of PRIMR. PRIMR creates IRB-ready digital patient education content for clinical trials by pairing board certified physicians with graphic designers and patient advocates. He practices medicine at a Yale-affiliate cancer center in Hartford, CT. In this episode we discuss how patient education happens at research sites, how to keep patients engaged through ongoing education, and how video content can improve patient care.2022-10-1441 min
Outcomes RocketRC: What Can We Do to Improve Clinical Trials? with Brad Hightower, CEO at Hightower ClinicalWelcome to the Research Confidential Podcast!
In this first episode, Brad Hightower, CEO at Hightower Clinical, talks about improvements that need to happen in clinical trial research. Brad details how he became CEO of his clinical research enterprise, one where he offered free research infrastructure to physicians who hadn’t been involved in any clinical trials before.
Throughout his years of experience, Brad observed and identified many improvable aspects, some of which he mentioned. He believes clinical trial criteria need to be adjusted to include a more general population set. Clinical trials suffer from a la...2022-09-2729 min
Note to File: A Clinical Research PodcastArdy Arianpour, SeqsterArdy Arianpour is CEO & Co-Founder of Seqster the leading healthcare technology company that puts the patient at the center of all their health data. He is a visionary health tech executive with 20+ years driving innovation in biotech and digital health. Prior to starting Seqster, Ardy launched several clinical and consumer-based genetic tests as CCO of Pathway Genomics, and served as SVP of Ambry Genetics, which sold to Konica in 2017 for $1 Billion. As a key player in the 2013 landmark SCOTUS decision scrapping gene patents, Ardy played an instrumental role in expanding genetic testing access with the...2022-09-2733 min
Note to File: A Clinical Research PodcastAndrea Valente and Jennifer Peters, ClinOneAndrea Valente spent the past 20+ years building global clinical trial tech organizations and technologies. Recently, Andrea was named CEO of ClinOne, a company that offers a virtual clinical trial platform for patients. Jennifer Peters had an idea to streamline payments between clinical trial sponsors and investigators, so she co-founded a company called Greenphire in 2008 which was acquired for $1.1 billion in 2021. She is also Board Chair of ClinOne. In this episode we discuss the relationship between patients and sites, the role of protocol design on participant engagement/retention, the technology adoption cycle, empowering patients by empowering s...2022-09-2254 min
Note to File: A Clinical Research PodcastBrittany Sloan, Tuskegee Syphilis Study, Part 2 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 part 2 of a 3 part series on the Tuskegee Syphilis Experiments presented by Brittany. 2022-09-1415 min
Note to File: A Clinical Research PodcastDr. Daniel Fox, Clinical Research Payment NetworkDr. Daniel Fox is a translational scientist with over fifteen years of experience in research, business development, and administration. He worked in academia, small startups, global giants, and finally in site administration where he found a particular passion to help physicians to get what they need for optimal research. Dr. Fox is the founder of the Clinical Research Payment Network and an advocate for the site's legal and financial rights In this episode we discuss the biggest budget and contract issues facing clinical research sites, industry fragmentation and how to change the site/sponsor dynamic when it...2022-08-3146 min
Note to File: A Clinical Research PodcastJoe Dustin, Medable Joe Dustin is Vice President of Product Strategy and General Manager for eCOA and Decentralized trials at Medable. He is responsible for the go-to-market strategy around Medable’s solutions and is working to define what decentralized trials will become with the professionals who are living it every day. For 20 years, Joe has been in the Clinical Trials Industry at the intersection of Technology, Innovation and Science. He has held a number of roles in IT, Project Management, Solution Consulting, Product Development and Sales at tech companies like Medidata and CRF Health, and most recently was t...2022-08-2549 min
Note to File: A Clinical Research PodcastDerk Arts, CastorDerk Arts has 15+ years of experience in medicine, research, and technology. He founded his company - Castor to solve the biggest issues in clinical research: a lack of inclusivity, patient focus, and impact of data. Castor enables sponsors worldwide to run patient-centric trials on a unified platform that helps them maximize the impact of research data on patient lives. Derk believes the key to achieving lasting change in the industry is through scalability and standardization. In this episode we discuss the current state of clinical trial technology, standardization of clinical trial data, the unleveraged power of research...2022-08-1950 min
Totally Clinical: Trial Triumphs & Rad TrendsHow Social Media is Shaking Up Clinical Research - Brad HightowerClinical research is a conservative industry, but one man is using social media to shake things up. Brad Hightower, CEO of Hightower Clinical, is leveraging LinkedIn to prompt open – sometimes difficult – conversations between sites and sponsors. During this podcast, Brad discusses his desire to give sites an online voice and his hopes for greater industrywide progress. “I think it's important to continue to have these conversations in a very open and transparent manner. I think if we want to progress, that's what we need to do. They're not always comfortable.” 2022-08-1617 min
Note to File: A Clinical Research PodcastRaj Indupuri, eClinical SolutionsA technologist with over 23 years of industry experience, Raj Indupuri is responsible for establishing the eClinical Solutions vision and future-looking technology strategy. He is deeply passionate about fostering innovation to revolutionize the Life Sciences industry with ground-breaking technologies that will modernize clinical trials and bring treatments to patients faster. As an industry veteran who has been part of the evolution of Life Sciences and clinical data management for over two decades, Raj has an astute business vision to realize the digital future and enable progress and potential with data and analytics at the core of the company’s innovative pr...2022-08-1037 min
Note to File: A Clinical Research PodcastBeth Baldys, inVibeBeth Baldys, as inVibe’s Head of Listening, is responsible for helping clients better understand their key stakeholders through deeper and more thorough listening. In addition to bringing patient voice to the forefront, she also works closely with the team to translate research findings into strategic and actionable insights for clients. Beth is a sociolinguist whose graduate research focused primarily on medical discourse analysis, which she continued to pursue throughout her entire career in market research. She brings 10+ years of experience, including past work analyzing doctor-patient communication. Her research has contributed to publications in Pain Medicine and Th...2022-08-0330 min
Note to File: A Clinical Research PodcastBrittany Sloan, Tuskegee Syphilis Study, Part 1Brittany 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 part 1 of a 3 part series on the Tuskegee Syphilis Experiments presented by Brittany.2022-07-2037 min
Note to File: A Clinical Research PodcastJoel White, Marketcap ConsultingJoel White is an independent consultant who founded Marketcap Consulting in June 2021 to help organizations, particularly those in the clinical research industry, improve their pricing, profitability, cash flow, and financial operations. Previously, Joel worked for about 15 years across large and small CROs leading various functions in proposals, pricing, finance, and contracting. In this episode we discuss so many site level budget and contract issues including pricing, cash flow and contract negotiations. This episode is packed with value for research sites.2022-07-1351 min
Note to File: A Clinical Research PodcastBree Burks, Veeva SystemsBree Burks is an ICU nurse turned clinical researcher turned technology enthusiast. She is currently the Vice President of Strategy, Site Solutions at Veeva Systems. In this episode we discuss the lack of practical training for clinical research sites, the frustrating universe of point solutions in clintech, the growing need for standardization in site operations and so much more.2022-06-2347 min
Note to File: A Clinical Research PodcastAlex Yant, Solutions Coordinator at SlopeAlex Yant is a Solutions Coordinator for Slope, the industry’s first eClinical Supply Chain Management software. He works to add order, trust, and predictability to your clinical research trials, so they end on-time and on-budget. Alex has four years of healthcare experience, as both clinical research professional and a direct service provider. He holds a bachelor’s degree from the University of Wisconsin-Madison, and a Master of Science in Occupational Therapy from the University of Illinois at Chicago. In this episode we discuss the significance of diversity of experience in clinical trials, the role of sites in c...2022-06-0840 min
Note to File: A Clinical Research PodcastBarry Lake, Devana SolutionsBarry Lake is the CEO of Devana Solutions, guiding the growth and expansion of the leading and most innovative software platforms for the clinical trials industry. Barry is a successful entrepreneur who has started and successfully grown several businesses over his career and has been actively involved in the healthcare space for well over a decade. Barry originally bought a site network with the intention of cashing out on the current site-consolidation trend fueled by private equity but pivoted to SaaS when he saw the need. Devana Solutions is driven by a core belief that performance data transparency through t...2022-06-0149 min
Note to File: A Clinical Research PodcastZina Sarif, YendouZina Sarif is a Cancer Scientist and Founder of Yendou. Yendou is on a mission to speed up clinical trials delivery from months to weeks and become a global community of principal investigators, patients and sponsors. Yendou connects healthcare innovators (sponsors) with healthcare providers and make clinical trials access and delivery for all sides only few clicks away. In this episode we discuss Zina’s journey from the lab to clinical trials, the mounting inefficiencies that plague our industry and the significance of site engagement.2022-05-2447 min
Note to File: A Clinical Research PodcastDoug Bain, KCRDoug Bain has been developing, implementing, and supporting clinical research systems since 1996 with a primary focus on EDC and DCT solutions. He was the founder and CEO/CTO of Clinpal, a DCT Platform. Since 2019, Doug has been the Chief Technology Officer at KCR - a mid sized global CRO. In this episode we discuss why clinical trial systems are so siloed, platform overload at sites, the future of decentralized clinical trials and the industry’s reluctance to discuss their failures.2022-05-1246 min
Note to File: A Clinical Research PodcastJasmyn AdamsJasmyn Adams is the Founder of The Clinical Research Associate Solution, LLC, an organization that provides career coaching for CRAs and aspiring CRAs, as well as CRA consulting, speaking, & workshop services for clinical research organizations. Jasmyn is also a Senior Oncology CRA, CRA Career Strategist, Speaker, and Podcast Host of Confessions of a CRA. Her dream is to make the CRA career so well known that it becomes one of the most common responses for children all over the world to the question, “What do you want to be when you grow up.” In this episode we disc...2022-05-0448 min
Note to File: A Clinical Research PodcastJane Myles, Decentralized Clinical Trials: Evidence of ImpactToday we welcome back friend of the show Jane Myles, VP Innovation at Curebase. Decentralized clinical trials are talked about so much nowadays but, all too often, we are left to guess whether they perform better or worse than hybrid and brick and mortar trials. In this episode we examine a real life example of a DCT in action including metrics against hybrid and brick and mortar sites in addition to addressing some of the myths that surround DCTs.2022-04-271h 07
Note to File: A Clinical Research PodcastArti Bhosale, Sieve HealthArti Bhosale is a Dentist turned Clinical Researcher. After completing dental school in India and moving to the US, Arti initially planned to continue in clinical dentistry. While completing her Master's degree she had the opportunity to be involved in oral cancer research and since then has made a conscious choice to continue in clinical research. 12 years have passed and Arti has held roles at site and industry levels. Arti is also the confounder of Sieve Health an AI/ML/NLP based advanced Clinical trial matching platform designed to benefit multiple clinical trial partners by enabling faster and diverse p...2022-04-2034 min
Note to File: A Clinical Research PodcastMark Shapiro, xCuresMark Shapiro is the COO of xCures and principal investigator for XCELSIOR and BEAT19, two patient-powered real-world data and outcomes registries in cancer and COVID-19, respectively. He has been focused on innovation and growth in clinical research for more than 20 years. Prior to joining xCures, Mark was SVP, Operations for a global CRO where he was responsible for a team of about 500 drug development professionals in 30 countries, and a portfolio of more than 100 active clinical trials. In his role at xCures, he has been focused on developing and implementing AI and Machine Learning-enabled software systems for clinical research. 2022-04-1345 min
Note to File: A Clinical Research PodcastRick Greenfield, RealTime CTMSRick Greenfield is the CEO and founder of RealTime Software Solutions, a leading Clinical Trial Management Systems provider. Rick also co-owned and managed one of the largest multi-specialty research sites in the US for nearly thirteen years where RealTime-CTMS was first created and implemented to streamline site operations for all staff and processes. RealTime, today, is bringing even more advancements to sites and sponsors that include eCONSENT, a Global Patient Portal to support fully or hybrid decentralized clinical trials and much more. In this episode we discuss the historical undervaluing of research sites, site’s role in dec...2022-04-0639 min
Note to File: A Clinical Research PodcastJane Myles, VP Innovation at CurebaseOur guest this week is Jane Myles (with an occasional guest appearance by her canine friend). Jane is a self-proclaimed clinical trial operations nerd. She’s had the opportunity to work on global drug development programs across many therapeutic areas but calls Hematology/Oncology her TA home base. Jane switched from molecule focus to portfolio focus about 12 years ago, first focused on patient recruitment, then patient voice and input, then patient facing technology and it's adoption. She’s able to merge them all together in her current role as VP Innovation at Curebase, building DCT technology and services to driv...2022-03-3045 min
Note to File: A Clinical Research PodcastMel Hardman, Site and Community Engagement, Faces of ResearchMel Hardman is a Certified Clinical Research Professional (CCRP) with over 15 years of progressive healthcare leadership and clinical research experience who has found her niche in site and investigator engagement, clinical trial patient recruitment and retention, protocol evaluation activities. Mel spends a lot of her time strategizing ways to improve diversity in clinical trials, closing the patient to science gap, and increasing awareness and visibility of clinical trials in communities of color. She has also consulted with start-up companies to improve their knowledge of optimizing recruitment funnels for technical platforms. In this episode we discuss the complexity...2022-03-2332 min
Note to File: A Clinical Research PodcastDeena Bernstein, VP of Customer Success at Datacubed HealthDeena Bernstein has been involved in the clinical research industry for 22 years. Her first 20 years were spent operating and developing site networks for large healthcare organizations, CRO's and IRO's. Currently Deena is the VP of Customer Success at Datacubed Health, a technology solutions provider. In this episode we discuss reducing site burden, gamification in the ePRO/eCOA space and the ever present silos in clinical research.2022-03-1629 min
Note to File: A Clinical Research PodcastRob Bohacs, ClinOneRob Bohacs is the Founder and Chief Solutions Officer of ClinOne, who works with world-class pharmaceutical companies to rethink and redevelop how clinical trials should be managed, with patient centricity at their core. Rob believes it is time to completely alter how we manage research site and patient interaction by bringing trials directly to patients to simplify a very complex process through technology and automation. In this episode we discuss site empowerment, the importance of measuring the patient experience and using decentralized clinical trial methods to strengthen the site and patient relationship.2022-03-0928 min
Note to File: A Clinical Research PodcastMatt Walz, TrialbeeMatt is the CEO of Trialbee, the leader in technology based patient matching, engagement and enrollment for clinical trials. Matt started his career as a software engineer and has been bringing innovative platforms to the Life Sciences market for the past 20 years. Prior to Trialbee Matt founded NextDocs, a venture-backed platform for regulatory and clinical document management and grew the company to 100 customers across North America, Europe and Asia before selling the company in 2015. In this episode, we discuss the goldrush in patient recruitment solutions, how sites manage technology, Facebook’s recent changes to targeted advertising, the im...2022-03-0240 min
Note to File: A Clinical Research PodcastDecentralized Clinical Trials, Site PerspectivesToday we’re deviating a bit from the standard podcast format and delving more deeply in to one topic – decentralized clinical trials. I feel we see a great deal of conversation around DCTs from sponsors, CROs and vendors but not as much from the sites themselves. This is my humble attempt bring the site voice a little bit more to the forefront in an increasingly overcrowded space. Our site voices today are Joy Jurnack and Dr. Viviënne van de Walle. Joy has a long and diverse career in clinical trials that includes roles as a cli...2022-02-2353 min
Note to File: A Clinical Research PodcastAdam Brown, ClinArkWe welcome back friend of the show, Adam Brown. Adam currently serves as the Chief Executive Officer at ClinArk and advisory board member at the Wittenberg Institute for Public Humanities and Sciences. Prior to founding ClinArk, Adam spent his entire career developing clinical trial strategies at some of the largest contract research organizations (CROs) in the world. He has a passion for increasing clinical trial awareness and access. In this episode, we discuss community engagement, the effects of COVID on clinical trials, and the continued rise of decentralized trials.2022-02-0926 min
Note to File: A Clinical Research PodcastAdam Walker, Biometrics SMEAdam Walker is a passionate biometrics subject matter expert with global exposure to the Pharmaceutical industry, having held a number of global Biometrics leadership roles within the pharma and the clinical arena. He is also co-host of the Huxley Morton Podcast, where he speaks to Pharma & Biotech Industry leaders and shares their stories of personal and professional growth. In this episode, we discuss the value of relationships, growth in the clinical research industry and the importance of self-awareness.2022-01-2643 min
Note to File: A Clinical Research PodcastDavid LaHaie, Great Lakes Research Institute/West Valley Research ClinicDavid LaHaie is the founder and co-owner of Great Lakes Research Institute (Detroit, MI) and West Valley Research Clinic (Phoenix, AZ). After spending over a decade in biotech business development he pivoted to clinical research site ownership and established a niche creating urban multi-specialty clinics and bringing clinical trial access to the underserved. In this episode, we discuss the transition from basic science to clinical trials, the benefits/downsides of various site models and the importance of incremental improvement. 2022-01-1236 min
Note to File: A Clinical Research PodcastRichie Kahn, Medable, #glaucomaniacRichie Kahn, MPH, is a health policy professional by training, clinical researcher by trade, and patient advisor by necessity. He is passionate about incorporating patient and caregiver perspectives into the clinical development process and ultimately reducing the time it takes to bring promising new therapeutics and diagnostics to market. In this episode we discuss what clinical trials can learn from public health, the importance of community engagement and the ongoing role of technology in decentralized clinical trials.2021-12-1540 min
Note to File: A Clinical Research PodcastBrittany Sloan, Black Research MattersBrittany Sloan spans 13 years of clinical research roles, personal leadership responsibilities and experiences, securing a robust career for herself while making notable contributions to research. Most recently, she's been on been on leave, reconfiguring her next steps for the future, especially through the lens of being a women of color. In this episode we discuss emotional intelligence in clinical research, the importance of a good team and the origin and mission of Black Research Matters.2021-11-2931 min
Note to File: A Clinical Research PodcastDanielle Coe, Black Women in Clinical ResearchDanielle Coe is an experienced Clinical Research Professional who is bringing diversity and much-needed change to our industry. She has helped countless professionals increase their reach and opportunities through Black Women in Clinical Research (BWICR) and Black Men in Clinical Research (BMICR). Presently, the organization has over 5,700 active members. The mission is to educate, empower, support, and help Black women and men thrive in the clinical research industry. In this episode we discuss Danielle’s journey from lab to clinic, the lack of diversity in the clinical trial workforce and the importance of marketing yourself.2021-11-0227 min
Note to File: A Clinical Research PodcastPatient Recruitment, volume 1Patient recruitment is still the crux of any successful clinical trial. In this series, we get tips, tricks and feedback from members of the clinical research community who are actively involved in patient recruitment efforts. In this episode we have Christine Narro, who discusses the importance of recruitment and it’s downstream effects, Ashley Heard who provides some insight to help increase subject diversity and Dr Christopher Gantz who discusses tips for developing a centralized recruitment program at the site level.2021-10-2045 min
Clinical Research EvolvedSite Networks with Brad HightowerOn this episode, Noah and John talk with Brad Hightower, the CEO of a site network to discuss the critical role of sites in clinical research and how that role is evolving.Find Out MoreBrad HightowerHightower ClinicalNoah Goodson, PhDJohn ReitesKyle Ricketts ClinicalResearchEvolved.comTHREADAbout the ShowOn Clinical Research Evolved, hosts Dr. Noah Goodson and John Reites talk with subject matter experts from across the life science industry to discuss the history, innovations, and...2021-10-0835 min
Note to File: A Clinical Research PodcastJay Pitts, ClinCeptJay Pitts is the President and CEO of ClinCept, a clinical research company committed to providing clinical research studies to communities across the Southeastern U.S. In this episode we discuss the importance of community engagement, customer service in clinical trials, and true patient centricity.2021-09-2932 min
Note to File: A Clinical Research PodcastElizabeth Weeks-RoweElizabeth Weeks-Rowe, LVN, CCRA, has 21 years of clinical research experience, including work as a study coordinator, CRA, CRA Trainer and CRA manager. She has been an Association of Clinical Research Professionals (ACRP), Certified Clinical Research Associate (CCRA) since 2004. She is a frequent speaker at clinical research industry conferences as well as a requested speaker at both ACRP and SOCRA local chapter events. She is a staff instructor for Clinical Research Fastrack, and works as a Principal CRA in study start up for a global CRO. In this episode we discuss the evolution of clinical research education, the...2021-09-2351 min
Note to File: A Clinical Research PodcastSticky Notes: Join us on ClubhouseThe clinical trial site community has spoken. Help us build a place where sites can come together to support one another, talk shop and share their experiences. Join us on Clubhouse on September 21st at 11:00 AM Eastern.2021-09-1701 min
Note to File: A Clinical Research PodcastTiffany Ashton, ClinEssentialsTiffany Ashton, from ClinEssentials, has been in the clinical research industry for over 18 years, holding positions such as Clinical Research Coordinator, Clinical Research Associate, and Clinical Trial Manager. In this episode we discuss tips for making the jump from CRC to CRA, the importance of relationship building and leveraging your network, and the significance of continual development and reflection throughout ones career in clinical research.2021-09-1345 min