Note to File
87 episodes - English - Latest episode: 5 months ago -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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Episodes
Kerri Weingard, Verified Clinical Trials
November 30, 2023 17:27 - 44 minutes - 35.5 MBKerri 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 creat...
Ignacio Handal, Clinicom
July 06, 2023 16:00 - 38 minutes - 31.1 MBIgnacio 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...
Thomas Peterson, Peterson Research Consulting
June 14, 2023 14:22 - 51 minutes - 41.6 MBThomas 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 di...
Jason Palasota, Clinitiative Health Research
May 31, 2023 16:14 - 49 minutes - 39.7 MBJason 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 a...
Rohit Nambisan, Lokavant
May 24, 2023 14:34 - 44 minutes - 35.8 MBTrained 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...
Brittany Sloan, Tuskegee Syphilis Study - Part 3
May 15, 2023 13:44 - 21 minutes - 17.6 MBBrittany 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-b99...
Whitney Stewart, Curebase
May 11, 2023 14:15 - 37 minutes - 30.1 MBWhitney 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-b9...
Amanda Santimaw and Rebecca Martinez, Arizona Arthritis & Rheumatology
April 26, 2023 15:28 - 42 minutes - 34.1 MBAmanda 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 rece...
Wayne Walker, Medidata Solutions
April 19, 2023 13:47 - 42 minutes - 33.9 MBWayne 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 ...
Charles Fisher, Unlearn
April 06, 2023 14:09 - 39 minutes - 31.8 MBCharles 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...
Amy Fox
March 22, 2023 14:01 - 46 minutes - 37 MBAmy 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 pediatric...
Dan Otap
March 15, 2023 15:00 - 48 minutes - 39.1 MBDan 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 (S...
Ethan Seville, Slope.io
March 01, 2023 15:41 - 53 minutes - 42.8 MBEthan 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 Shaw, Innovative Trials
February 22, 2023 15:13 - 41 minutes - 33.5 MBKate 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 discu...
Scott Stout, MedVector
February 15, 2023 20:03 - 43 minutes - 34.7 MBScott 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 Farg...
Jennifer Bonfrisco, Corlexia Clinical Services
February 08, 2023 15:44 - 46 minutes - 36.9 MBJennifer 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-friendl...
Mitchell Hilbe, Kenzona Clinical Research
February 01, 2023 10:51 - 42 minutes - 34.3 MBMitchell 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 Rese...
Steve Rosenberg, uMotif
January 25, 2023 16:28 - 48 minutes - 38.5 MBSteve 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 u...
Dr Michael Koren, ENCORE Research Group
January 18, 2023 14:05 - 31 minutes - 25.1 MBMichael 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 presiden...
Gunnar Esiason, Florence Healthcare
January 10, 2023 14:51 - 43 minutes - 34.6 MBGunnar 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, ...
Shawn Blackburn, YPrime
January 03, 2023 14:02 - 46 minutes - 36.8 MBAs 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 c...
Michelle Shogren, Innovate In What You Do! LLC
December 05, 2022 15:28 - 44 minutes - 36 MBWith 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 ...
Mike Wenger, VersaTrial
November 23, 2022 14:42 - 48 minutes - 39.2 MBMike 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, h...
Sylvain Berthelot, Calyx
November 16, 2022 14:35 - 40 minutes - 32.7 MBSylvain 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 t...
Archana Sah
November 09, 2022 11:52 - 51 minutes - 41.4 MBArchana 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 M...
Dr Leigh Mack
November 07, 2022 10:00 - 50 minutes - 40.7 MBDr. 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...
Dr David Grew, PRIMR
October 14, 2022 14:15 - 41 minutes - 32.9 MBDavid 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.
Ardy Arianpour, Seqster
September 27, 2022 12:41 - 33 minutes - 26.8 MBArdy 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 landma...
Andrea Valente and Jennifer Peters, ClinOne
September 22, 2022 12:42 - 54 minutes - 43.6 MBAndrea 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 re...
Brittany Sloan, Tuskegee Syphilis Study, Part 2
September 14, 2022 16:16 - 15 minutes - 12.1 MBBrittany 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.
Dr. Daniel Fox, Clinical Research Payment Network
August 31, 2022 14:09 - 46 minutes - 37.3 MBDr. 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 a...
Joe Dustin, Medable
August 25, 2022 13:32 - 49 minutes - 39.7 MBJoe 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, Solutio...
Derk Arts, Castor
August 19, 2022 13:33 - 50 minutes - 40.8 MBDerk 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 ep...
Raj Indupuri, eClinical Solutions
August 10, 2022 01:58 - 37 minutes - 30.4 MBA 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...
Beth Baldys, inVibe
August 03, 2022 14:05 - 30 minutes - 24.1 MBBeth 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 care...
Brittany Sloan, Tuskegee Syphilis Study, Part 1
July 20, 2022 14:03 - 37 minutes - 29.8 MBBrittany 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.
Joel White, Marketcap Consulting
July 13, 2022 13:18 - 51 minutes - 40.8 MBJoel 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 cont...
Bree Burks, Veeva Systems
June 23, 2022 13:36 - 47 minutes - 38.1 MBBree 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.
Alex Yant, Solutions Coordinator at Slope
June 08, 2022 13:50 - 40 minutes - 32.1 MBAlex 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 Illinoi...
Barry Lake, Devana Solutions
June 01, 2022 09:30 - 49 minutes - 39.4 MBBarry 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 pi...
Zina Sarif, Yendou
May 24, 2022 09:04 - 47 minutes - 37.7 MBZina 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 i...
Doug Bain, KCR
May 12, 2022 14:25 - 46 minutes - 37.2 MBDoug 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.
Jasmyn Adams
May 04, 2022 13:20 - 48 minutes - 38.7 MBJasmyn 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 ...
Jane Myles, Decentralized Clinical Trials: Evidence of Impact
April 27, 2022 11:00 - 1 hour - 53.7 MBToday 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.
Arti Bhosale, Sieve Health
April 20, 2022 12:17 - 34 minutes - 27.2 MBArti 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...
Mark Shapiro, xCures
April 13, 2022 12:00 - 45 minutes - 36.5 MBMark 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. I...
Rick Greenfield, RealTime CTMS
April 06, 2022 11:03 - 39 minutes - 31.4 MBRick 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 ...
Jane Myles, VP Innovation at Curebase
March 30, 2022 12:01 - 45 minutes - 36.7 MBOur 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...
Mel Hardman, Site and Community Engagement, Faces of Research
March 23, 2022 12:00 - 32 minutes - 25.7 MBMel 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 o...
Deena Bernstein, VP of Customer Success at Datacubed Health
March 16, 2022 12:00 - 29 minutes - 23.3 MBDeena 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.