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Note to File

Brad Hightower

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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.
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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 recrui…
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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 …
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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 t…
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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 con…
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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 Pr…
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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 …
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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 public…
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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 me…
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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 year…
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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.…
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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 a…
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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 executio…
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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 clini…
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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 clinica…
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Scott 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, “Beyo…
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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 s…
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Mitchell 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 K…
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Steve 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…
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Michael 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/M…
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Gunnar 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…
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As 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 …
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With 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…
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Mike 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 Ver…
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Sylvain 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, …
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Archana 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 …
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Dr. 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 s…
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David 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 ed…
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Ardy 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 C…
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Andrea 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…
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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 o…
  continue reading
 
Dr. 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…
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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 Tr…
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Derk 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…
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A 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 t…
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Beth 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 …
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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 1 of a 3 part series o…
  continue reading
 
Joel 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, p…
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Bree 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 …
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Alex 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 …
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Barry 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…
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Zina 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 side…
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Doug 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 s…
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Jasmyn 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…
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Today 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 aga…
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Arti 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.…
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Mark 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 …
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Rick 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 proces…
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Our 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 foc…
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Mel 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 imp…
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Deena 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 burde…
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