Executive Director, Program Strategy, Rare Disease and Pediatrics, Premier Research, https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/, https://eurofinscentrallaboratory.com/biopharma-services/, eurofinscentrallaboratory.com/biopharma-services, Hyatt San Francisco Airport, Burlingame, San Francisco, Best practices for engaging the patient community and growing that relationship using real life case studies. https://www.threadresearch.com/, To learn more , please visit our website - THREAD is a leading provider of a proprietary, decentralized research platform and suite of supporting services used by biopharma, CROs and life science organizations to remotely capture data from participants and sites during, in-between and in lieu of in-clinic visits. Signant unites eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industrys most comprehensive patient-centric suite an evolution built on more than 20 years of proven clinical research technology. Learn more atwww.clinone.com. Vice President, Clinical Operations, Corvus Pharmaceuticals Inc. Assistant Commissioner for Import Operations, U.S. Food and Drug Administration, Director, Global Patient Engagement and Advocacy, Acceleron Pharma, Associate Director, Site Contracts & Budgets Deciphera Pharmaceuticals, LLC, Program Director, Office Of Medical Device And Radiological Health Operations, FDA. Medables completely modular approach allows pharmaceutical companies and clinical research organizations (CROs) to use only what they want, while scaling capabilities to better suit their unique studies. http://www.yprime.com/, To learn more , please visit our website - Amy has been a drug discovery and development professional for 25+ years, including progressive roles in clinical operations and clinical strategy. To learn more , please visit our website - She has executed a variety of clinical trials involving therapeutic areas including autologous breast reconstruction, heart failure, hypertension, arrhythmia management and erectile dysfunction. Curebase is also pioneering the Bring Your Own Physician (BYOP) model, allowing patients the comfort to make decisions with support from their trusted physician, To learn more , please visit our website - www.curebase.com. https://lifesciences.transperfect.com/, To learn more , please visit our website - Headquartered in Sydney since 1996, Novotech has come to be recognised as the CRO of choice for many US and European biotechnology firms in the Asia Pacific. www.curebase.com, To learn more , please visit our website - 2022 edition of Outsourcing in Clinical Trials & Clinical Trial Supply East Asia Conference will be held at InterContinental Seoul Coex, Seoul starting on 29th November. The main program of the conference is discussion and debate on the outsourcing of clinical research. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials. Bringing together nearly 700 professionals, TFS delivers tailored clinical research services in more than 40 countries. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences. Other companies he has founded or co-founded include: 1) IMTH, a real estate investment trust with properties through the state of California; 2) iPill Dispenser, a medical device that uses a mobile app to control a secure, stand-alone pill dispenser to prevent opioid sharing, diversion, and drug overdoses; and 3) NAOMI systems, a practice management software company that integrates digital X-rays devices in PACS, EMR and RCM billing modules. The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients. Kris OBrien is an Executive Director in Program Strategy, specializing in Rare Disease and Pediatrics, at Premier Research. To learn more , please visit our website - https://www.threadresearch.com/. We are now in the position now to share our practical experiences with Decentralized & Hybrid Clinical Trials; The bedrock of a successful trial is a well-designed protocol with reliable measurements of biomedical and health-related outcomes to satisfy regulatory standards. Attendees. Local vendor oversight vs global provider oversight how would you manage this differently? To learn more , please visit our website - http://www.premier-research.com/. Liza Melchor-Khan is a Senior Director of Clinical Operations at NGM Biopharmaceuticals, Inc. with over 25 years of experience in the biotech and pharmaceutical industry. Richard holds a Ph.D. in Industrial Engineering with a focus on applied statistics, quality, and reliability engineering from Arizona State University (ASU), a Master of Science in Industrial Engineering focused in Operations Research and Production Systems (ASU) and a Bachelor of Science in Engineering in Industrial Engineering (ASU), and is certified as a Six Sigma Black Belt. Topics: Together with our client partners, we are fulfilling our purpose of Advancing medicine, improving lives., To learn more , please visit our website - https://www.nucleusnetwork.com/au/. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. Our platform consists of 13 modules that cover every aspect of clinical trials, from project startup to pharmacovigilance. With an agenda covering the future of Clinical trials, patient centricity, digitalization and drug development post COVID, Clinical Trials Innovation Programme 2023 will feature tailored sessions presented by the leading experts and service providers from across the globe. To learn more , please visit our website - Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Altasciencesis a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to preclinical and early phase clinical studies, from lead candidate selection to proof of concept. CROMSOURCEis unparalleled in offering an end-to-end guarantee covering trial timelines, enrollment, and price. Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. www.greenlightclinical.com, To learn more , please visit our website - Their services include clinical monitoring, clinical monitoring oversight, clinical trial management, data management, biometrics, and medical writing. Scalable, Reliable. ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). Our Sponsor Edition includes dedicated applications for clinical study planning and budgeting, outsourcing and forecasting. I am the CEO at OrPro Therapeutics, a biotechnology company in San Diego, CA developing biologic drug solutions to unmet needs in serious epithelial diseases including cystic fibrosis. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Our scientific knowledge base, technical expertise and reputation for high quality services have been integral to our ability to turn our services into your solutions. La Jolla, CA. clinical trials Conferences 2023/2024/2025 is for the researchers, scientists, scholars, engineers, academic, scientific and university practitioners to present research activities that might want to attend events, meetings, seminars, congresses, workshops, summit, and symposiums. Her experience in a multitude of therapeutic indications has led to an acute knowledge of study conduct and execution with a keen focus on protocol dynamics. eurofinscentrallaboratory.com/biopharma-services. To learn more , please visit our website - Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. In this position, she focuses on initiatives for employee development or training and topics to advance health literacy for underserved communities as it relates to clinical trial access. She has extensive experience in managing complex projects, with a strong focus on building and maintaining relationships at both company and industry level from an operational role within the organization. To learn more , please visit our website - Meghan McKenzie works in Patient Inclusion and Health Equity in Genentechs Chief Diversity Office. This is also a critical time to determine the development strategy for later study phases. Currently a Medical Director/Patient Safety Physician Digital & Devices at Astrazeneca. News; . We provide a comprehensive digital solution for Ph 1-4 studies with enterprise-level capability that is configurable to be fit for purpose to support biopharmaceutical companies, CROs and research sites. Review and assess the selection criteria sponsors face when selecting Phase I jurisdiction. http://www.cromsource.com/. To learn more , please visit our website - To learn more , please visit our website - He received his medical degree (MD) and his doctoral degree (PhD equivalent) from Justus-Liebig-Universitt Giessen, Germany, and his Master of Business Administration (MBA) from the Wharton School of Business, University of Pennsylvania, PA. Kunal Sampat is the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. Our collaborative approach helps maximize efficiency and agility by acting as an experienced member of your team. SDC delivers top-tier clinical trial services to pharmaceutical, biologic and device/diagnostic companies. Lin holds a Master of Science in management from the Stanford University Graduate School of Business and a master's in marine biology from Sun Yat-sen University in Guangdong, China. Pharmaceutical Development. Includes management of the RFP process for outsourced services as well as contract/proposal and budget negotiations, vendor selection, and vendor oversight/relationship management. Henry earned his B.S. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. Trial enrollment accounts for 60% of the total time of the trial and for 80% of trial failures. Her experiences in academia, biotech, and CROs confirm that meeting the needs of all stakeholders payers, regulators, patients, families, and sites is a critical success factor for efficient development programs. Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. 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. Contact: ESMO Registration Office; Phone: [+41 (0) 91 973 19 13]; Email: registration@esmo.org. AWT Healthcare manufacturers clinical trial labels. How data mining clinical trial costs and benchmarks can lead to operational efficiencies, The impact of macroeconomic factors on clinical trials and how to best combat changes, How to reimagine financial stability and planning for clinical trials, Clinical Trials: Success & attritions. Jowita Marszewska, Ph.D. is a Scientific Advisor at Clario, a global data and technology company that helps minimize risk in clinical trials. Clinical research professional with 25 years of experience in clinical and medical affairs, most recently as Director of Clinical Affairs and Associate Director of Medical Affairs for a global medical device manufacturer focusing on endovascular and surgical repair of aortic disease. Dr. Marszewska has experience with electronic data capture and data management in clinical research. Partnerships in Clinical Trials Europe 2020. Zigzag aims to provide straightforward, reliable and flexible Quality Assurance and auditing services on a local or global basis. Artificial intelligence in medicine & clinical trials. Keeping them can be an even bigger challenge. It is the go-to solution in over 1,000 sites and 40 countries enabling investigators and sponsors to simply record, review, anonymise and submit assessments to regulatory bodies. To learn more , please visit our website - AbbVie reports rise in full-year 2022 net revenues; Teva Pharmaceutical reports 5% fall in Q4 2022 revenue; Merck reports 2% increase in worldwide sales in Q4 2022; Companies. Today she serves as the Chief Strategic Officer for Potrero Medical, a Hayward, California-based predictive health company developing the next generation of medical devices with smart sensors and artificial intelligence. This event is a great opportunity to get to know the online casino players who will be [] Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. www.maxisit.com/ctos/. 30+. To learn more , please visit our website - She also has worked within the clinical department at several reputable companies like Axogen, Medtronic, Coloplast and CR Bard. This conference will focus on topics such as bioethics, regulations, patient recruitment, site selection, data integration & strategy, and many more. She is currently managing a Ph3 program in rare liver disease. Exploring new science and a futuristic perspective on AB/AM drug development, Exciting growth of artificial intelligence in medicine, A framework on development of artificial intelligence in medicine, The power of public attention and funding, Business opportunity of artificial intelligence in medicine, What they like to see in an outsourced partner organization, What they would like a partner to know about them / how they work. Booth #4. OMDRHO is one of five programs in the Office of Medical Products Operations within FDAs Office of Regulatory Affairs.