Dr. Yunis is a scientist with multidisciplinary training and experience in the mechanism of diseases. as a Microbiologist, HQ position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import Operations Branch. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence,Worldwide Clinical Trialsprovides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies. Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs. To learn more , please visit our website - We develop new innovations, drive emerging therapies forward and improve patient lives. In this role, Mr. Chu develops, manages, and evaluates inspectional matters for DWCI covering all FDA import activities associated with air and sea port operations in the States of Hawaii, California, Nevada, Oregon, and Washington. Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. www.Clario.com, To learn more , please visit our website - www.greenlightclinical.com, To learn more , please visit our website - http://www.clindatrix.com/. Her background in Biotechnology and proficiency in Data Management solidified her proven ability to identify data integrity risks, and problem solve the most complaint path to drug submissions and approvals. Contact: ESMO Registration Office; Phone: [+41 (0) 91 973 19 13]; Email: registration@esmo.org. She has worked at several companies in positions of increasing responsibility including VP of Quality at InterMune (acquired by Roche) and Director of Quality at CV Therapeutics (acquired by Gilead). Our experts are ready to discuss how our solutions can best support your live studies. Joined industry with a goal of developing digital and devices to improve patient care. Emvenio Research is transforming how patients and care-givers engage in and experience clinical research, To learn more , please visit our website - Currently, Audrey Funwie works in the Patient Inclusion and Health Equity team of Genentechs Chief Diversity Office. Boring clinical trials are better clinical trials. Taking a Data Science approach to gain financial oversight of clinical trials. http://www.celerion.com. View Event. Global Player in eClinical Solutions . She is currently managing a Ph3 program in rare liver disease. November 28-30, 2016 San Antonio, USA. Dr. Hayat is managing partner of Revive Pharm USA. She has a unique perspective in leading clinical programs in a dynamic startup environment. Ndidi Rickert is an experienced Quality Assurance leader with over 20 years of experience in the Pharmaceutical/Biotechnology industry. Learn more atwww.clinone.com. To learn more , please visit our website - Estela is an exceptional community engagement liaison for both English and Spanish speakers. Founded and operated as a more customer centric and nimblealternative to traditional CROs, KPS offers a full range of services leveraging the latest clinical technologies. We go beyond traditional events and offer, The main program of the conference is discussion and debate on the outsourcing of clinical research. Dr. Lindsay Hughes, Director of eCOA Clinical Science and Consulting at Clario, is a scientist and leader with over 15 years of experience in behavioral and life sciences. Ms. OBrien has been conducting clinical research for more than 35 years and has covered multiple functions during that time. To learn more , please visit our website - For more information, please contact us at 262-334-6020, or via email at Daniel.Selness@spauldingclinical.com. With the most trusted review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra optimizes research performance, empowers clinical sites, and ensures compliance. Our Sponsor Edition includes dedicated applications for clinical study planning and budgeting, outsourcing and forecasting. Best practices for managing CRO governance for small/start-up companies with limited resources or large companies with competing priorities, Driving success in either unexplored settings or in saturated market settings, Maintaining Chain of Identity/Chain of Custody, Evolving Technologies & Regulatory Guidance documents, Roel of Project Management in helping to drive and streamline cross functional communication, Key considerations for communicating timelines and milestones, Maintaining focus on Quality centric culture, Using machine learning to increase efficiency, Leveraging interoperability to streamline operations. Featuring solutions for automated referrals, eConsent, patient engagement, connected devices, eCOA, and eSource, ClinOne makes participating in a clinical trial a little easier, every day. She is currently Director of Patient Safety Medical Device for AstraZeneca and supports products across the enterprise. In his role as BD lead, he is responsible for many aspects of the companys planning and operations. 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. Session Reserved for Worldwide Clinical Trials, Data Management: Programming and metrics in medical device studies, Vast experience of over 20 years in Quality, Regulatory, Processes Improvements and leading cross organization projects, VP Quality Assurance, Regulatory Affairs and Clinical at IceCure Medical, since September 2020, leading the company compliance and clinical affairs, Prior to joining IceCure Medical, held a position of Director of Quality, Regulatory and Customer Support at Applied Spectral Imaging (ASI) and Several positions at Carestream Health (formerly Orex Computed Radiography). Attendees. https://www.calyx.ai, To learn more , please visit our website - This presentation will discuss: With increasing site staff/physician burnout and sites taking on less projects, we are still feeling the ripple effect of this on trials. Stop by to see us at Outsourcing in Clinical Trials New England 2021 conference. Date: January 18 - February 17, 2023. 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. To learn more , please visit our website - Explore Modern RTSM Solutions. Medical Writing and Healthcare Communications Conference. Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. Arvinder received her undergrad in Biophysics and doctorate in Cardiovascular Physiology from University of Manitoba, Canada. Versiti Clinical Trials Services support biopharma and cell therapy companies through central laboratory, logistics, biomaterials provision, and IRB services. Our leading clinical show will focus on providing delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials, this is an [] Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. www.bsi-lifesciences.com. TORONTO, March 23, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions . Kumar earned his Ph.D. from the University of Vermont and was a post-doctoral fellow at the University of Virginia. Slope makes clinical trials boring by using real-time data to orchestrate operational complexity. We atMyonexadd value to our clients by helping them always be prepared for what is next in their clinical trials. Read more . To learn more , please visit our website - http://www.medable.com/. A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers. To learn more , please visit our website - ACM Global Laboratories is one of the largest global independent central labs in the industry. The news service . For more than 20 years, Axiom has delivered data-driven, powerful and cost-effective eClinical Solutions and Services dedicated to small-to-medium life science companies. Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. http://www.endpointclinical.com/. theactigraph.com. This is because many conference attendees are likely to be active online casino, President, Healthcare Advocate, Looms For Lupus, Executive Director, Program Strategy, Rare Disease And Pediatrics, Premier Research, Inclusive Research and Health Equity - gRED ECD Clinical Operations,Genentech, Director Patient Innovation Center, Patient Insights, Parexel. We are an embedded partner dedicated to the success of your study, offering managed services such as: Data Management, On-Demand Data Analytics, Biostatistics, Clinical Management, eTMF Management and Pharmacovigilance. The Technology track will seeKimberley Ferguson(Commercial Head of Personalized Healthcare Partnerships, Genentech) discussing all thingsWearables. Join us in Philadelphia, May 10th-11th, to shape best practice on: Refining patient recruitment strategy. THREAD provides key platform features such as eConsent, eCOA/ePRO, sensors, reminders, and telehealth Virtual Visits to support remote data capture, hybrid virtual studies, and fully decentralized studies in key therapeutic areas. Axiom Exhibiting at Outsourcing in Clinical Trials Southeast 2022. In her role at Nevro, Frances is responsible for leading the data management team, driving the adoption of new technologies and innovative data management processes to bring new treatments to patients. With presentations and panel discussions on the top industry trends and outsourcing challenges, and . The impact DCT has on diversity, equality and inclusion (DEI) have we finally managed to tap into under-represented communities? Are you choosing best in class or a bundle? https://www.sdcclinical.com/. Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible. Outsourcing in Clinical Trials Southern California 2022. https://www.discoverinternational.com/. Intrinseque Health is an EN ISO 13485 certified Global Clinical Supply Chain organisation, building & executing complex Clinical Supply Plans for Ancillary, Medicinal products, Clinical Supplies, Equipment and Services required by Pharmaceutical & Biotech companies and CROs for their Clinical Trials. Basel, Switzerland. He has been actively involved on both sides of the business in managing CDMOs and CROs. Dublin, March 01, 2023 (GLOBE NEWSWIRE) -- The "Clinical Trials Outsourcing Market Share, Size, Trends, Industry Analysis Report, By End-Use, By Therapeutics Area, By Workflow, By Region, Segment . Optimizing CRO Success: Relationship, contribution and oversight, PANEL DISCUSSION Defining your outsourcing strategy to contain costs and accelerate drug development time-to-market: what should you consider in the new COVID-19 era, Executing clinical trials on a shoestring: Optimizing the CRO Functional Service Provider model. Saamas unified, AI-driven clinical data analytics cloud platform seamlessly integrates, curates, and animates unlimited sources of structured, unstructured, and real-world data to deliver actionable insights across all therapeutic areas. 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. Their services include clinical monitoring, clinical monitoring oversight, clinical trial management, data management, biometrics, and medical writing. She has over 22 years of experience overseeing GxP quality and compliance for all phases of drug development for biologics and small molecules. Ops components of various FIH studies and global P1-P3 drug development programs and post-marketing studies in Oncology, Hematology-Oncology, Immuno-Oncology, Infectious Diseases, Immunology, Metabolic Diseases, Ophthalmology, and Critical Care conducted in North America, Europe, Africa, Central and South Americas, Asia-Pacific regions including Japan, China, So Korea, and Australia *Lead cross-functional teams and successfully contributed to several INDs, NDAs, FDA, EMEA, TGA, and NMPA regulatory filings and approvals of marketed products within HIV/Virology Therapeutic Area *Mentor, motivate, and develop clinical operations teams and direct reports *Strong, flexible, strategic team leader with extensive change management successes *Track record to develop, problem-solve, and execute creative and innovative process improvements and quality efficiencies within development operations *Motivated and driven to continue contributing to drug development in transformative medicines with a focus on unmet medical needs, CLOSING KEYNOTE: ClinOps team focus: Managing relationships, retention and hiring in the new world. To learn more , please visit our website - www.eclinicalsol.com. Ellen Weiss is the Vice President, In-Home Solutions, Decentralized Clinical Trials at PCM Trials. Advarra advances the way clinical trials is conducted to make them safer, smarter, and faster. Meghan received her Masters Degree in Human Biology at San Francisco State University and her Bachelors Degree in Economics at University of North Carolina, Chapel Hill. WORKSHOP: Identifying and overcoming the hurdles associated with global studies including longer timelines, drawn-out budgets and remote teams. eCOA is our core focus but not our only service. 4G Clinical, a leader in randomization and trial supply management (RTSM) for the global life sciences industry, is sponsoring the 2022 Outsourcing Clinical Trials DACH. By tapping into patients rich and varied health journeys on Inspire, researchers and health practitioners around the world are advancing treatments and making breakthrough discoveries. Henry earned his B.S. Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. Bruce started his career on the faculty in the Chemistry Department at Purdue University where his independent research focused on neuronal signal transduction. To learn more , please visit our website - To learn more , please visit our website - www.pro-ficiency.com. OMDRHO's Key Initiatives, inspectional and compliance activities, Define RWE and real-world data sources/needs, Making progress during pandemic for a first-in-human device study, Designing a hybrid trial for a novel interventional device, Navigating the complexities of multi-specialty study, Determining the technologies to move studies off site in order to move forward with the new norm, Investigating technology to save costs and improve accuracy of pharmacokinetic and pharmacodynamic data, Learning how to improve study drug adherences so only the study participant has access and, can only take the drug as per study protocol, Case Study looking at Digitization for objective data and cost saving, Defining the reimbursement strategy to prove medical benefit and value, Understanding codes for medical device technologies, Working with the FDA to secure your reimbursement, Programming for efficient data management, Generating metrics for data tracking and study progress, Overview of how we interface with our organization, Discussing the technologies accessible for the smaller biotechs, Assessing how to make access to innovations affordable for companies on a smaller budget and how to best allocate limited resources, How to work with a vendor partner as a smaller biotech to get access to new technologies, Removing the barriers: what still needs to be done to improve access to innovation for all, Key drivers for trial enrolment and in time completion, Population and high prevalence of disease in developing countries, Barriers and hurdles to access vast pool of patients, Strategies/solutions to penetrate through barriers and pass hurdles, Common operational, security and regulatory issues around the collection, management, and reporting of essential clinical trial documents, How eTMF solutions can help to address these issues, and ensure inspection-ready and regulatory compliant storage of trial content, How eTMF solutions reduce business risk, improve team collaboration and productivity, reduce auditing and reporting costs, and ensure enhanced artifact quality, Major capabilities that current eTMF solutions should provide. Medrio is the leading provider of eClinical technology for pharma, biotech, device, diagnostics, and animal health clinical trials. Dr. Raymond completed her doctoral training in molecular biology at University of California San Diego and post-doctoral training in molecular biology at Memorial Sloan-Kettering in New York City, New York, USA. 2023. April 28-29, 2016 Dubai, UAE. CROMSOURCEis unparalleled in offering an end-to-end guarantee covering trial timelines, enrollment, and price. Additionally, our tech-enabled trial management system, streamlined study startup processes, centralized pre-screening call center, and unparalleled approach to patient recruitment will successfully deliver a superior CRO experience. She has authored or co-authored 10 publications and has been an advocate for STEM education throughout her career. Dr Morimoto has over 25 years of industry experience in leading project teams in the development of innovative medicines, providing guidance in the design and execution of preclinical, clinical and regulatory strategies with a therapeutic focus in Parkinsons, Alzheimers and frontotemporal dementias. By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Outsourcing In Clinical Trials East Coast 2022. Prior to TransPerfect, Jay directed teams on moving several enterprise product platforms to the cloud at Medidata and Sparta Systems. Any Where. February 28, 2023. . Phase 1 Trials: How to globalize to accelerate value inflection. IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. For more than 40 years, Emmes has been dedicated to research for a healthier world. Of the several programs he worked at Pharma and Biotech companies, three culminated in making to the market [PaclitaxelTM Bristol-Myers Squibb; SensiparTM Amgen and DuexisTM - Horizon Therapeutics). www.promedica-intl.com. Read more. Patient Inclusion and Health Equity, Chief Diversity Office, Genentech, Vice President, In-Home Solutions, Decentralized Clinical Trials, PCM Trials, Executive Director, Clinical Operations, Terns Pharmaceuticals. Home / Events /. Panellists will discuss the challenges and tech barriers with DCT. March 14 . TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey.