To learn more , please visit our website - To learn more , please visit our website - Current topics in the Medical Device Regulatory Landscape, Presented by the FDA. Advarra integrated solutions connects life sciences companies, CROs, research sites, investigators, and academia at the intersection of safety, technology, and collaboration. Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. Pharmaceutical Development. CROMSOURCE is an international contract research organization providing a comprehensive services to the pharmaceutical and biotechnology companies. Commercial Services. Rhonda has more than 30 years of experience in FDA, starting as an ORA Investigator in Portland, OR before becoming a manager located in FDA's Minneapolis office. Electronic clinical outcome assessments (eCOA)and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. She has held key national leadership roles including advisor within the Obama/Biden administrations global HIV response team, advisor to United Nations leadership and instructor at the CDC and USAID. We atMyonexadd value to our clients by helping them always be prepared for what is next in their clinical trials. This session examines how scientific rigor can be applied to clinical outcome assessments (COAs) even though they are subjective. WHAT TO EXPECT FOR 2023? Consulting Dermatologist, Clinical Development & Medical Affairs RAPT Therapeutics, Inc. Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. Anne Reid is the Program Director of the Office of Medical Device and Radiological Health Operations (OMDRHO). Dr. Richard Abelson, President & CEO of Statistics & Data Corporation (SDC), founded the company in November of 2005. Keeping them can be an even bigger challenge. To learn more , please visit our website - http://www.clinicalink.com/. To learn more , please visit our website - She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. https://lifesciences.transperfect.com/, To learn more , please visit our website - With 2,000 annual trials and projects, around 200 active clients and global access to source drugs in over 60 countries,Myonex is your complete partner around clinical trials around the globe reliable, trusted and by your side. CA; X-Mine, CA; Delphian Pharma, CA and Certum LLC, CA). Amy has been a drug discovery and development professional for 25+ years, including progressive roles in clinical operations and clinical strategy. https://www.anjusoftware.com/, To learn more , please visit our website - She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. Prior to SDCs inception, Richard served on the Board of Directors of Ora, Inc. (www.oraclinical.com) for over 10 years. INTERACTIVE SESSION: Establishing and maintaining strong CRO/sponsor relationships and building trust in a more virtual landscapeWhat have we learned and what should we focus on? Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORAs Office of Import Operations. To learn more , please visit our website - https://www.advancedclinical.com/. Partnerships in Clinical Trials Europe 2021. From 2 to 4 November 2020. An opportunity at Gilead Sciences sparked her move to the West Coast, and she is now settled in the San Francisco Bay Area. Why the current state of trials makes it difficult for patients to participate in research, How and when to incorporate patient insights into your programs, How to create a business case to garner support for investing in solutions, The benefit for the study sponsor, and other stakeholders, for investing in solutions to make it easier to be a participant, Barriers to patient participation with a focus on the barrier that became the impetus of the model, Delving into benefits of Patient Navigators and challenges with consistent comprehensive support for patients, Exploring the Enhanced Patient Support Services, Cover proactive strategies to address performance risk and protocol deviations, How to apply performance data from simulation-based training to manage risk areas, Discuss how to interpret and apply learning results to optimize and de-risk your DCT, Rethinking your site management strategy to minimize overburdening sites, dependant on the phase of your study, Pinpointing how site turnover impacts the sponsor and how to help reduce it whilst keeping patient care front of mind. Recognising how Social Determinants of Health contribute to outcomes in disease, Assessing which communities you arent successfully recruiting from and exploring data to understand why, Focussing on education in this space and what we can all do moving forward. Catalyst Clinical Research is a new generation Clinical Research Organization, serving the unique needs of small-to-medium sized biopharmaceutical companies. www.rad-md.net. YPrimescloud-based technology streamlines clinical trial data collection and management. About Mobile Technologies in Clinical Trials. We go beyond traditional events and offer, The main program of the conference is discussion and debate on the outsourcing of clinical research. With an agenda covering the future of Clinical trials and drug development post COVID, Clinical Trials Innovation Programme 2023 will feature tailored sessions presented by the leading experts from across the . I went into industry for post-doctoral studies at the biotechnology research center at Ciba-Geigy Corp. (Novartis) and have over three decades of academic and industrial research and senior management experience in protein and metabolic engineering, bio-based manufacturing, and drug discovery / development. Services are available in U.S., Canada and ROW. News; . Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible. His thesis was on the role of the Androgen Receptor in Hormone Refractory Prostate Cancer. To learn more , please visit our website - http://www.pcmtrials.com/. Supported by top pharmaceutical and biotech partners across 20 different therapeutic areas, Care Access is scaling and globalizing its new model for clinical trial delivery, where more physicians and patients can engage in life-saving research to develop new therapies faster. April 25-27, 2016 Dubai, UAE. After years of watching the opioid crisis develop, John has developed an innovative drug and dispenser to safely treat pain and deter abuse. It offers its clients a global reach through a network of 38 processing laboratories. He started his career with FDA in 1998. Proven ability to organize and manage late-stage development cross-functional teams completing projects on time with meticulous attention to detail. Embassy Suites Raleigh-Durham Research Triangle, Cary, NC. Effective management of essential clinical trial documents using eTMF solutions. http://www.arensia-em.com/. . Funwie strives to do meaningful work that combines and applies her bioethics background while prioritizing and addressing health equity in the context of clinical studies, patient experience, and policy. There, he employed a broad range of methodologies, including: visual psychophysics, neuropsychological and computer-based cognitive assessments, eye tracking, electrophysiology, and structural imaging. This Clinical Trials Conference includes a wide range of Keynote presentations, Plenary talks, Symposia, Workshops, Exhibitions, Poster presentations and Career development programs. Joined industry with a goal of developing digital and devices to improve patient care. His expertise is in regulated content management, and he is a member of the TMF Reference Model Project Team. Pro-ficiency converts training from a cost center to a powerful quality improvement system. Executive Director, Clinical Outsourcing and Alliance Management, BridgeBio Pharma, Inc. VP Digital Transformation Strategy, Medable, Sr. Director, Clinical Operations NGM Bio, Vice President, Drug Development, Alto Neuroscience, VP Clinical Trial Financial Management, Medidata, Product Director, Decentralised Trial Technology at YPrime, Health Technology - Clinical Research, Meta, Director, eCOA Science & Consulting, Clario, Associate Director, Quality Culture Excellence, Ultragenyx Pharmaceutical, Solutions Consultant, eClinical Solutions, Associate Director of Clinical Operations, CymaBay Therapeutics, Associate Director, Global Regulatory Clinical Services, Global Outsourcing Director, Development Operations, Ascendis Pharma, Sr. Clinical Operations Professional, Imago BioSciences, Senior Director Of Clinical Affairs , Materna Medical, RN, MSN, CCRC, CCRA, Senior Manager of Clinical Affairs and Field Operations Ancora Heart, Deputy Program Director, Office of Medical Devices and Radiological Health Operations (OMDRHO), ORA, FDA, Director, Global Clinical Shared Services at Stryker Neurovascular, Vice President Of Clinical Affairs, Endogenex, Director, Clinical Programs, Clinical Affairs, ReCor Medical, Director, Database Management, Nevro Corporation, Director Global Patient Safety- Device And Digital Health, AstraZeneca, Medical Director, Patient Safety Physician Digital & Devices, AstraZeneca, VP Quality Assurance, Regulatory Affairs And Clinical, IceCure Medical, Vice President, Product Management, Anju Software. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve live. He has supervised the management of a clinical portal, eTMF, CTMS, RTSM, EDC, Coding and Grants solutions. Outsourcing In Clinical Trials East Coast 2022 User Dashboard. Minimize site activity- could decentralization and Direct-to-Patient trials be the answer to staff shortages? She is a Registered Respiratory Therapist, holds the CPPS (Certified Professional in Patient Safety) credential from IHI and has a Masters degree from Johns Hopkins in Patient Safety and Healthcare Quality. http://catalystcr.com/. The elluminate Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. Developing successful communication pathways in a more remote world. More recently, Arun headed to Santen, with a focus on driving operational excellence in Ophthalmology clinical research as Associate Director Global Clinical Development and Operations, where he oversees Phase 1 4 clinical trial conduct. Emvenio Research is transforming how patients and care-givers engage in and experience clinical research, To learn more , please visit our website - Join Premier Research at Outsourcing in Clinical Trials Southern California 2022 as it returns for its 9 th annual event. The "Global Clinical Trial Outsourcing Market by Clinical Trial Phase, Therapeutic Area, End-user and Region: Competition Forecast and Opportunities to 2027" report has been added to .
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