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A podcast for clinical research sites - interviews, best practices and candid commentary from Brad Hightower, founder of Hightower Clinical and clinical research professional.

11/21/2023

Come talk clinical trials with this weeks guest Jason Palasota.

10/10/2023

Come talk all things clinical trials including Dr Fox's recent SCRS experience.

07/11/2023

Come talk about the newest DCT Draft Guidance with Scott Stout of MedVector

07/06/2023

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

06/27/2023

Clinicom Demo - Expanding equity and access to CNS trials with Ignacio Handal.

06/14/2023

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

05/15/2023

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

03/22/2023

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 ex*****on of clinical trials. Knowledgeable in academic and large healthcare settings, as well as public health and private physician practices. Her areas of expertise focus on early phase human pharmaceutical clinical research in the specialties of pediatrics, oncology, neurology, cardiology, infectious disease, dermatology, and diabetes.

This week we discuss the increasing complexity of clinical trials operations, connecting SOPs to processes and the difference between QC and QA.

03/15/2023

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

03/01/2023

Ethan Seville is a clinical research professional who has worked in a wide range of indications across various roles such as patient recruitment, coordinating, quality assurance, management, and regulatory. Ethan is now the Manger of Customer Engagement and Strategic Solutions for Slope.io, which helps researchers by ensuring their network of clinical trial patients get the exact medical supplies their care requires on time, on schedule and on budget.

In this episode, Ethan interviews me 😳.

02/15/2023

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, “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.



This week we discuss the problem with physician referrals, how more doctors can get involved with clinical research without becoming investigators and how sites can have a more active role in an ever evolving decentralized environment.

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