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Kunal has over 18 years of experience managing and conducting clinical trials. Be sure to stop by to visit my colleagues at booth #60. Based outside Philadelphia, Pennsylvania, we pride ourselves on being boutique by design and always customer focused. Our mission is to optimize the Clinical Trial Ecosystem, applying industry experience and the latest technology to streamline, secure, and enhance the interactions between sponsors, sites, CROs, and others involved in administering and operating clinical trials. 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. Any Disease. http://www.clindatrix.com/. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners most high-profile drug and device programs. PANEL DISCUSSION: The concept of DCT, is it the future? IRT Interactive Response Technologies - Informa Connect Medocitys platform captures valuable real-time clinical insights & real-world data, while engaging patients, sites, and sponsors. Our innovative network of Mobile Research Sites, At Home Visits and Technology Enabled Virtual Visits are a unique blend of global DCT capabilities that can be deployed to better reach, recruit and retain diverse patient populations, while improving their clinical trial experience. TORONTO, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions and services focused on small-to-medium life science organizations, will be exhibiting at Outsourcing in Clinical Trials New England 2022, October 12-13 in Boston, MA. 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. She has a wealth of knowledge and experience having served more than 24 years in ORA managing staff and operations focused on medical devices, radiological health, and MQSA. https://www.threadresearch.com/, To learn more , please visit our website - 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. It is a 2 day event organised by Arena International Events Group and will conclude on 24-May-2023. Regional Director, Business Development, Novotech, Executive Vice President Business Development, Nucleus Network, VP of Clinical Development, Rani Therapeutics, VP of Clinical Operations, CymaBay Therapeutics, Inc, Associate Director, Clinical Operations, Santen, Senior Lead, Global Compliance and Strategy, Medidata, Therapeutic Strategy Lead, Gene Therapy Think Tank, Worldwide Clinical Trials, Vice President, Quality Iovance Biotherapeutics, Vice President, Program Management, Iovance Biotherapeutics, Head of Product, Trial Interactive, TransPerfect, M.A. 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). Pro-ficiency converts training from a cost center to a powerful quality improvement system. ACM Global Laboratories is one of the largest global independent central labs in the industry. www.viedoc.com, To learn more , please visit our website - Running clinical trials in 2022: what you need to know Global Clinical Trials Connect 2023 2022 London United Kingdom CISCRP Conferences - Clinical Research Industry TrialMaster, IRMS MAX, and TA Scan, the companys flagship products, lead the way in reducing complexities in the drug and device discovery and commercialization process. Caroline Cooper is the Director of Clinical Operations at CymaBay Therapeutics, Inc. with over 10 years of experience in clinical research. Our full service offering includes clinical program management, biometrics services and regulatory affairs. AWT Healthcare manufacturers clinical trial labels. Currently, Audrey Funwie works in the Patient Inclusion and Health Equity team of Genentechs Chief Diversity Office. Outsourcing Clinical Trials New England 2022. Global Clinical Trials Connect 2023 2022 London United 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 - Analytical & Solid State Services. He is a key member of the leadership team responsible for defining the company's go to market strategy and value proposition across the many segments of the pharmaceuticals and device research industry. Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. To learn more , please visit our website - http://www.labconnectllc.com/. We have five years of clinical trial experience and capabilities around the globe in over 90 countries and across any therapeutic area whether for decentralized, hybrid or fully virtual studies. 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. He received M.Sc. Mr. Luciano earned a B.A. December 07-09, 2015 Atlanta, USA. www.promedica-intl.com. Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022. Outsourcing Clinical Trials New England - BURG Translations November 13-14, 2023 Dubai, UAE. With nearly a decade of home visits learnings, Ellen has a unique perspective on how decentralized clinical trials have changed over the years and what the future looks like. She has 20+ years of diverse global experience in the biotechnology industry including roles within Clinical Development, Medical Affairs, and Risk Management. degree in Neurobiology and is the author of several peer-reviewed papers in prostate cancer and premature ovarian failure. She has authored or co-authored 10 publications and has been an advocate for STEM education throughout her career. This conference is always a great opportunity to share and learn with our colleagues across the industry. http://www.heartcorsolutions.com. To learn more , please visit our website - NikZ shows promise against other important fungal diseases. To learn more , please visit our website - Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. The last decade of this time has been solely focused on the investigator grant administration domain driving strategy and leading teams implementing payment technology in both BPO and enablement models. With over 40 years experience, 600 beds and locations in NA, EU and Asia, Celerion conducts First-in-Human, clinical Proof-of-Concept and patient dose response studies, cardiovascular safety and NDA-enabling clinical pharmacology research. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture. Arun Sivanandam has more than 12 years of experience in clinical research at site and sponsor side. Her clinical development experience spans all therapeutic areas and all stages of the clinical development lifecycle, from natural history studies through registrational global trials, and Long-Term Follow Up and Post Marketing surveillances.