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. www.td2inc.com. Estela is an exceptional community engagement liaison for both English and Spanish speakers. Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. 8 th Pharmaceutics and Novel Drug Delivery Systems Conference. Rated 4.5 by 2 people. From 2 to 4 November 2021. She currently serves as Vice President of Clinical Affairs at Endogenex, a medical device company developing innovative solutions for the treatment of Type 2 diabetes. 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. KEYNOTE: Seeing your site as a partner and identifying best practices for reducing site-burden, Seeing your site as a partner and identifying best practices for reducing site-burden, Clinical Operations leader with extensive bio-pharmaceutical and CRO industry experiences (20+years) *Develop and implement strategic Clin. Includes management of the RFP process for outsourced services as well as contract/proposal and budget negotiations, vendor selection, and vendor oversight/relationship management. To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionalscollaborateswith biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Outsourcing In Clinical Trials East Coast 2022 User Dashboard. Whether you require ad hoc support or a team to partner with on audit programs, we have the people, the expertise and the experience to provide the assistance you need. Login; Register now; Toggle navigation. Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. www.curebase.com, To learn more , please visit our website - . His thesis was on the role of the Androgen Receptor in Hormone Refractory Prostate Cancer. Communities. Anju is a portfolio company of Abry Partners serving the worldwide pharmaceutical, biotech and contract research Life Sciences markets. We are committed to delivering high-quality, cost-effective services according to sponsor timelines and specifications. 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. Ms. Lea is the Director of Global Patient Engagement and Advocacy for Acceleron, a wholly-owned Subsidiary of Merck. . Clinical Trials conferences 2023 are large-scale multidisciplinary events well attended by clinical researchers, media partners, renowned speakers, sponsors, scientists, exhibitors, and other attendees. Rho, a contract research organization (CRO) located in Chapel Hill, NC, provides a full range of services across the entire drug development process. She has actively participated in departmental preparation for the EU CTR implementation and is one of ICONs SMEs on this topic. We contribute to a safer and better world by helping our sponsor clients accelerate drug and device approvals to market. Through Inspire you will access a unique blend of data longitudinally across patients health journey to draw insights that accelerate medical progress and improve healthcare. Electronic clinical outcome assessments (eCOA)and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. Combining OCT, CTS and Medical Devices events, this is the perfect platform for professionals from . In a separate article, Manasi Vaidya discovers that, fuelled by the successful use of mRNA vaccines in Covid-19, RNA therapeutics are expected to make larger strides in 2022.. Based on available data, there are emerging trends . Pro-ficiency converts training from a cost center to a powerful quality improvement system. Local vendor oversight vs global provider oversight how would you manage this differently? The Outsourcing in Clinical Trials Texas event aims to be a solution-driven conference that allows Clinical Operations professionals to network with innovative vendors, hear cutting-edge content, and participate in interactive discussions. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience. She has a unique perspective in leading clinical programs in a dynamic startup environment. Sandy Mohan is the VP of Quality at Iovance Biotherapeutics. Previously, Arvinder has worked at CV Therapeutics and Gilead Sciences where she led various projects from early discovery to clinical development. 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. Scout Clinical, part of the Meeting Protocol Family, provides stress-free, confidential and personalized travel, expense and compensation management services to clinical trial participants on a global scale. IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Liza has extensive experience in managing and overseeing phase I-IV clinical trials globally as well as building and growing clinical operations teams in oncology, cardiovascular, metabolic and liver diseases, HIV and trials in gene therapy. 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. 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. Discuss a pathway to extend biotech cash burn runway while still meeting Phase I objectives and meeting investor expectations! Contact us for more information and for a live demo tailored to your use case and needs. FDAs role in maintaining a secure and resilient supply chain. www.kardia.com. The 15th Annual Outsourcing in Clinical Trials New England event will bring together clinical trial professionals from big and small biopharma to uncover new technologies and processes, to optimize their clinical and outsourcing operations. Our Ergomed team is looking forward to exhibiting at Outsourcing Clinical Trials - Texas 2022, December 7th & 8th . Review and assess the selection criteria sponsors face when selecting Phase I jurisdiction. Contact: Amy Apostoleris, aapostoleris@medocity.com, To learn more , please visit our website - www.pro-ficiency.com, To learn more , please visit our website - MedPoint Digital develops intuitive, ICH-GCP compliant eClinical platforms for virtual investigator meetings, trial portals, interactive modules, and virtual clinical trials. Dr. Debashish Niyogi is currently Vice President, Product Management at Anju Software, where he is responsible for the vision, strategy, and roadmap for the companys eTMF and CTMS solutions. Employee turnover continues to impact global market for talent. 21 October 2022 Outsourcing In Clinical Trials - Texas 2022. Analytical & Solid State Services. www.deeplink-medical.com. 3 rd Clinical Pharmacy Conference. Partnerships in Clinical Trials Europe 2022. This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. 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. medtech.labcorp.com. She became the Deputy Program Director for OMDRHO in 2017 and ultimately became OMDRHO Program Director in February 2022. To learn more , please visit our website - www.assistek.com, To learn more , please visit our website - We proactively plan, coordinate and write clinical documents to meet timelines, with a readability that reduces the time for review and approval. 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. The award-winning platform gives unprecedented real-time visibility into clinical data, enabling sponsors to file New Drug Applications (NDAs) more efficiently to bring drugs to market faster and at lower costs. To learn more , please visit our website - Advarra integrated solutions connects life sciences companies, CROs, research sites, investigators, and academia at the intersection of safety, technology, and collaboration. 5 th Global Pharmacovigilance Summit. 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. Since our establishment in 2004, we have conducted over 700 phase I clinical trials, with 80% of our clients consisting of US based biotech and pharmaceutical companies. To learn more , please visit our website - Our commitment to excellence, innovative technologies, and therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Examining how, even as a small company with limited resources you can successfully introduce time and cost saving QMS measures. Minimize site activity- could decentralization and Direct-to-Patient trials be the answer to staff shortages? Combining medical expertise and deep industry knowledge, we develop bespoke solutions to accelerate your innovative treatment development for patients with unmet needs, one trial at a time. Finding patients is a challenge. At Strategikon Pharma, we bring a high level of precision and speed to outsourced clinical trial operations through our flagship SaaS platform, Clinical Maestro. Based outside Philadelphia, Pennsylvania, we pride ourselves on being boutique by design and always customer focused. Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. The Decentralized Clinical Trials hybrid event, April 18th - 20th in Boston, will provide leading insights and practical guidance on how to decentralize your clinical trials for greater diversity, accessibility and efficiency, with guidance a world-class speaker line up. Diagnostic Services. Prior to starting SageMedic, he was an Associate Professor at UCSF. Looking forward to another great conference! To learn more , please visit our website - 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. Making progress of a complex Interventional device study during covid. ACM performs more than 20 million laboratory tests each yearspanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more. Reimbursement for medical devices in trials, and, understanding the process. In another exclusive data-led investigation, Andrew and Reynald Castaeda investigate which diseases are set to have an increase in clinical trial activity this year. To learn more , please visit our website - www.pro-ficiency.com. We have been driving the success of our clients, consultants, and employees in staffing and consulting services since 2004. Greenphire is the industry leader of clinical payment technology, designed to improve the way research professionals work. CROMSOURCE is an international contract research organization providing a comprehensive services to the pharmaceutical and biotechnology companies. Chief Executive Officer, Agility Pharmaceuticals, Dr Mishra (Ex Genentech, Ex NCI, Ex NIH) is the founding president and CEO of the American Association for Precision Medicine ( and chair of ACT AAPMs Coronavirus Taskforce He is leading research efforts focused on preventing curing chronic diseases not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives He is also the founder and CEO of Agility Pharmaceuticals, a pharmaceutical company committed to revolutionizing drug discovery development through technology, big data, robotics, and artificial intelligence He is a serial entrepreneur who founded his first company after graduating high school, and his second company during his Ph D Since then, he has accumulated a wealth of experience by building, investing, and advising numerous other companies He is an investor, co founder/ board member of a few corporations, focused on accelerating drug discovery/ development, data analytics, robotics, mental health, and digital health He is also the founder of AAPM Angels and Investors AAi an investment group focused on investing in drug discovery, diagnostics, precision medicine, technology healthcare companies He is also the founding investor and advisor to Barcelona Ventures and serves as an advisor to a 100 M private equity fund Widely recognized as a thought leader in the field of technology and healthcare, Dr Mishra has keynoted, chaired, curated, and organized numerous successful international conferences He served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche Where he participated in several drug discovery project teams Moreover, his passion for drug development and precision medicine has led to the identification of new drug targets, biomarkers, companion diagnostics, and several drugs/ combinations in the clinic His research work has been recognized globally by over 40 prestigious awards and honors Due to his unique perspective selfless service, he is a highly respected sought after mentor to many The companies that he has advised have raised multimillion dollars Notably, he serves as a mentor and advisor to several VC funds and startup accelerators, including IndieBio HIMSS/Health 2 0 s Project Zygote, MedLabs ZGC Capital, J&J JLabs UCSF Innovation Venture, UCSF Invent Fund, and California Life Sciencess FAST program, to help grow Californias life sciences innovation ecosystem, Chief Executive Officer, Strategikon Pharma. It is a 2 day event organised by Arena International Events Group and will conclude on 24-May-2023. 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. Triomics is a technology company offering an enterprise-grade platform for clinical trial sites to automate data collection practices. After completing her education in England, Ndidi began her career working for Parexel followed by Merck Sharp & Dohme. Please email me if you'd like to set up a meeting to discuss your upcoming clinical trials: To learn more , please visit our website - http://www.axiommetrics.com/. Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. To learn more , please visit our website - Following its virtual success over the COVID lockdowns, we are pleased to forecast the 2022 live edition will attract even more, with a great speaker line up and up to date content. Myonexis a global complete clinical trial solutions provider. To learn more , please visit our website - Philips BioTel Research is an industry leader in medical imaging and cardiovascular safety testing for clinical trials. Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. 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. Orbis Clinical is a leading global life science recruitment partner. Specifically for Clinical Trials and RWE studies, Medocitys modular and flexible architecture ensures swift configuration and deployment in less than 4 weeks, through a fully interoperable and connected SaaS cloud database. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018. Clinical ink is the global life science company that brings data, technology, and patient science together. http://www.cromsource.com/. To learn more , please visit our website - Dr. Richard Abelson, President & CEO of Statistics & Data Corporation (SDC), founded the company in November of 2005. He has been a visiting professor at Catholic U., Louvain, Belgium and U. Pittsburgh, Pittsburgh, PA and visiting speaker at Humboldt U. in Berlin, Germany. Per the FDA, Decentralized Clinical Trials (DCT) hold promise to reduce patient and sponsor burden and increase accrual and retention of a more diverse trial population, Designing clinical trials with technology in mind can empower and power studies. 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. To learn more , please visit our website - An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps. 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. www.versiticlinicaltrials.org, Viedoc designs engaging software for the life science industry. To learn more , please visit our website - 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. Over the past 30 years his focus has been in the areas of drug substance as well as drug product R&D, manufacturing and outsourcing the small molecules as well as biologics. To learn more , please visit our website - 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. Basel, Switzerland. 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. Where do the opportunities lie for further acceleration in clinical development? To learn more , please visit our website - Dr Jankicevic holds Doctor of Medicine degree, Master of Medical Sciences degree, and Board-certification in Dermatology and Venereology from the University of Belgrade, Serbia. Practical use cases to improve clinical site efficiency with technology. Aug 09 International Conference on Drug Development, Clinical Trial Phases and Technology (ICDDCTPT) - Lagos, Nigeria. Francis is an expert in clinical system regulatory compliance with over 20 years pharma experience spanning R&D, manufacturing and clinical research. For more information, visitwww.eclinicalsol.com, or contact us atinfo@clinicalsol.com. Dr. Cunningham has over 15 years experience in clinical leadership position in medical device industry, overseeing a full spectrum of clinical development programs ranging from FIM to pivotal to post-market phases. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. As a community leader and healthcare advocate she partners, collaborates with initiatives including the U.S. Department of Health and Human Services Office of Minority Health and the U.S. Food and Drug Administrations Office of Minority Health and Health to increase awareness on the need for diversity in lupus clinical trials, All Of US Research, Scripps Digital Trials Center and Congresswoman Grace Napolitanos Mental Health Consortium.