Note to File

Kerri Weingard is a founding partner and global chief operating officer at Verified Clinical Trials (VCT). VCT is the largest global research subject database to reduce dual enrollment and prevent protocol violations. Ms. Weingard is also the CEO and founder of Study Scavenger and Clinical Hero. Both companies are dedicated to clinical trial recruitment and education. Ms. Weingard, who is a nurse practitioner, holds a master’s degree in science from Stony Brook University. She, before creating VCT and Study Scavenger, has conducted over 500 clinical trials as a research administrator and sub-investigator. She has more than two decades of experience in the field and is a member of a number of professional organizations, including the American Society for Clinical Pharmacology and Therapeutics, the Drug Information Association and the Association of Clinical Research Professionals.

Ignacio Handal is the CEO at Clinicom Healthcare. Ignacio has completed a multitude of FDA phase I, II, & III studies in pharmaceuticals, and devices over two decades. In 2022 Ignacio was honored with one of the highest honors in Clinical Research, the Christine Pierre Clinical trials lifetime achievement award of which only 8 clinical researchers globally have ever been awarded.

Early in his career Ignacio, Co-Founded the 5th leading private CNS research site in the US called Harmonex Neuroscience research in 2003 that continues excelling to this day.

Ignacio and his team have used 100% of the profits of their research trials over the last twenty years to develop the world's first online mental health assessment software that can assess anyone remotely for 81 mental health conditions in one virtual adaptive ML assessment. Clinicom has helped patients all over the world find answers on their mental health journey. Clinicom has also helped accelerate enrollment and patient identification for precise inclusion and exclusion criteria in 70 phase II and III studies in the US. The Clinicom mission is to give every patient a voice and to bring equity and access to mental health. Clinicom currently serves patients on 6 continents.

This week we discuss how to improve site selection, the challenges of vendor selection, and how Clinicom was born from a site.

Ignacio Handal on LinkedIn:  https://www.linkedin.com/in/iggyhandal/

Clinicom on the web: www.clinicom.com/overview

Learn more about our sponsor, Veeva Vault: http://sites.veeva.com

Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY

Thomas Peterson has been in healthcare for approximately 17 years now. A vast majority of that experience is in clinical research. He has served in many capacities such as a Research Assistant, Study Coordinator, Senior Study Coordinator, Clinical Research Associate and now Senior Clinical Research Associate. He founded his own consulting company to assist anyone in the clinical research space that needs guidance. Thomas works within the oncology, neuro-oncology, rare disease, infectious disease spaces as well as pediatrics.

 This week we discuss the shift from CRC to CRA, humanity in clinical trials, the downstream effects of “innovation” in the industry and so much more.

 Thomas Peterson in LinkedIn:  http://www.linkedin.com/in/thomas-peterson-6173a7228

 Peterson Research: www.peterson-research.com

 Learn more about our sponsor, Veeva Vault: http://sites.veeva.com

 Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY

Jason Palasota had always been passionate about improving the quality of clinical research services delivered to patients. He first got his feet wet working on the ground level as a site coordinator for Cetero Research, formerly known as Diabetes and Glandular Research. From there, he began to develop an even deeper respect for the industry and continued to pursue opportunities that would allow him to drive change. After working on the ground level, he was inspired to make an impact and improve the quality of clinical research services delivered to patients. Determined to bring about positive change, Jason worked his way up from proposal development and inside sales roles to external business development positions at Worldwide Clinical Trials, ResearchPoint Global, and IQVIA (formally Quintiles). As Jason gained more experience in this field, he became increasingly aware of significant relationship and communication gaps that existed within the industry. He was determined to bridge these gaps by forming strong partnerships between exceptional clinical research sites and innovative sponsors/CROs. His goal was simple: make a positive difference in people’s lives through top-tier healthcare solutions around the world. Clinitiative Health Research was born.

This week we discuss the various business development models for sites, why sites might want to consider partnering with a business development vendor, and the incredible significance of relationships in clinical research.

 Clinitiative Health Research on Linkedin: https://www.linkedin.com/company/clinitiative/ 

 Clinitiative Health Research on Twitter: https://twitter.com/ClinitiativeHR ,

 Clinitiative Health Research on Facebook: https://www.facebook.com/ClinitiativeHealthResearch

Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY

Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Rohit was most recently the Head of Digital Product at Roivant and the Head of Product at Prognos Health. Rohit holds an M.S in Management and Engineering from MIT, an M.A. in Neuroscience from Boston University, and a B.A in Cognitive Neuroscience from UC Berkeley.

In this episode we discuss fragmentation amongst study stakeholders, the importance of real time data that’s agnostic to source, and the impact of decentralized clinical trials and an increase in disparate data sources.

Rohit Nabisan on LinkedIn: https://www.linkedin.com/in/rohitnambisan/

Lokavant website: https://www.lokavant.com/

Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY

Brittany Sloan is the Director of Black Research Matters, a safe space exclusively for Black people to learn more about research with the purposes of being becoming better-informed decision-makers thus strengthening the community by using knowledge as a tool to navigate the medical and healthcare systems.

This episode is the conclusion of a 3 part series on the Tuskegee Syphilis Experiments presented by Brittany.

Brittany Sloan on LinkedIn: https://www.linkedin.com/in/whitney-stewart-b9969326/

Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY

Whitney Stewart is the director of clinical project management at Curebase. She has served the clinical research space for more than 10 years, and holds bachelors' degrees in Molecular and Cellular biology, and Italian Studies.

 In this episode we discuss evidence standards for digital therapeutics and the recent Digital Therapeutics Alliance publication “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard”.

Whitney on LinkedIn: https://www.linkedin.com/in/whitney-stewart-b9969326/

Digital Therapeutics Alliance and Curebase release publication setting the stage for a fit-for-purpose evidence standard for digital therapeutics (DTx): https://www.curebase.com/news/digital-therapeutics-alliance-and-curebase-release-publication-setting-the-stage-for-a-fit-for-purpose-evidence-standard-for-digital-therapeutics-dtx

Learn more about our sponsor, Inato: https://go.inato.com/41YxjXY

Amanda Santimaw is the Director of Clinical Research for the 9 locations of Arizona Arthritis & Rheumatology, plus 4 external physician locations. She is responsible for the oversight of over 180 current clinical trials, 17 Principal Investigators, 24 dedicated research staff working in rheumatology, gastroenterology, endocrinology, and internal medicine. She has 15 years of experience working in Phase I-IV clinical trials, observational studies, and retrospective data analysis. Amanda received both her Bachelors of Science and Masters of Science in Clinical Research Management from Arizona State University. When Amanda is not at work, she enjoys spending time with her husband, daughter and new baby, going hiking, camping, and traveling

Rebecca Martinez is the Operations Manager of Clinical Research and is Amanda’s co-pilot for all the locations. She has over 10 years’ experience in the clinical research field in rheumatology and gastroenterology.  She is responsible for the successful study start-up, recruitment, and maintenance for all the ongoing trials. She too received her masters of science in clinical research management from ASU.

This week we discuss the challenges of managing site level documents, making the jump to electronic regulatory with Veeva, CTMS, eSource and so much more.

Wayne Walker is Senior Vice President, Product for Rave Platform Technology (including Rave EDC, Rave RTSM, Rave Imaging, Rave Coder, and Rave Safety Gateway) at Medidata. His responsibilities include the strategy, development, and delivery of these products across all Research & Development disciplines. Before joining Medidata, Wayne spent 12 years overseeing Product Management for clinical technology used by Data Management and Biometrics at PRA Health Sciences. This involved oversight of Platform as a Service, Software as a Service, on-premise deployed environments, and in-house developed solutions

This week we discuss the vendor/site relationships, why there is a proliferation of disparate systems, the potential of direct to EDC data entry and so much more.

Charles Fisher is the founder of Unlearn which is using AI to simulate potential health outcomes for individual patients.

Charles is a scientist with interests at the intersection of physics, machine learning, and computational biology. Previously, Charles worked as a machine learning engineer at Leap Motion and a computational biologist at Pfizer. He was a Philippe Meyer Fellow in theoretical physics at École Normale Supérieure in Paris, France, and a postdoctoral scientist in biophys.ics at Boston University. Charles holds a Ph.D. in biophysics from Harvard University and a B.S. in biophysics from the University of Michigan.

This week we discuss digital twins, the impact of AI on clinical trials, clinical trial data ownership and much more