Over 20 years in clinical research, including patient innovation, feasibility, strategy, patient recruitment, retention, site engagement. . 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. 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 . The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. She holds medical license issued by Serbian Medical Chamber. To learn more , please visit our website - Exploring incentives for the community if not financial what else can you offer? Each year, we bring forward the latest experience . Reem enjoys working in startups bringing forward long-term vision and strategies. Altasciences helping sponsors get better drugs to the people who need them, faster. Pharmapack is the European event focal point for the pharma packaging and drug delivery device industry. To learn more , please visit our website - Partnerships in Clinical Trials Europe 2022. 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. 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. AliveCor, Inc. is transforming cardiological care using deep learning. 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. Dr. Yunis is a scientist with multidisciplinary training and experience in the mechanism of diseases. http://www.axiommetrics.com/. Flex Databases platform is a secure, unified and compliant system for clinical trials. Overview. Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. Medidata is leading the digital transformation of life science, with the worlds most used platform for clinical development, commercial, and real-world data. Theyll ensure your translations will be of the highest quality, on time, and within budget. He also served on multiple FDA Headquarter working group and committee related to Food Safety Modernization Act (FSMA), import process improvement, strategic framework, rapid screening technology, and partnership agreements. Please email me if you'd like to set up a meeting to discuss your upcoming clinical trials: We offer Bioanalysis for small molecules and biologics for PK, immunogenicity and biomarkers utilising the platforms of LC-MS/MS (7) and Immunoassay (MesoScale, Gyrolab). ACM performs more than 20 million laboratory tests each yearspanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more. Imaging endpoints are often used to support go/no-go decision-making in early phase trials. 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. It seamlessly integrates with EMR, lab, genetic mapping and APCD data, as well as EDC, CTMS and iRT systems to support site and patient identification. You might have known us as Myoderm as we have recently changed our name but not our high-quality services as the complete clinical trial supply partner. He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. Collaterally with her Regional Food and Drug Director duties, Anne served as the acting program director for both the Biologics and Tobacco programs during significant planning phases for program alignment. Join Premier Research at Outsourcing in Clinical Trials Southern California 2022 as it returns for its 9 th annual event. Our goal each day, every day is to make sure our partners have whatever they need when and where they need it to execute a successful clinical trial, while also minimizing delays, unnecessary costs, and surprises. ), both from Duke University where I was also an undergraduate. The DIA's Digital Technology in Clinical Trials Conference discovers how digital technology is transforming the drug, device, and diagnostics development process in clinical trials. Dr. Apfel is an internationally known authority on designing, conducting, and publishing highest quality clinical trials with thousands of patients that have changed medical practice with over 100 peer-reviewed publications. Chris has dedicated his 16-year career to the services side of the Phase I clinical drug development industry, including both operational and business development roles. As the IPM, he is the District liaison to FDA Headquarter handling import related issues and concerns. 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. 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. May 02-03, 2016 Chicago, USA. November 13-14, 2023 Dubai, UAE. WCG measurably improves the quality and efficiency of clinical trials, helping biopharmaceutical companies, CROs, and institutions facilitate the development of new treatments and therapies for patients. Login; Register now; Toggle navigation. Ellen brings decentralized clinical trial visits to patients with PCM Trials experienced Certified Mobile Research Nurses. September 28-29, 2022. http://strategikonpharma.com, To learn more , please visit our website - ProTrials Research, Inc., is a full-service clinical research organization (CRO) and woman-owned business headquartered in San Jose, CA, with clinical operations personnel located throughout North America and across the world. Arena International are delighted to announce Outsourcing in Clinical Trials West Coast will be returning to Burlingame for the annual event on March 1st & 2nd 2023! After completing her education in England, Ndidi began her career working for Parexel followed by Merck Sharp & Dohme. Saama Technologies is the advanced clinical data and analytics company, unleashing wisdom from data to deliver better actionable business outcomes for the life sciences industry. 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. She has 20+ years of diverse global experience in the biotechnology industry including roles within Clinical Development, Medical Affairs, and Risk Management. 4240 La Jolla Village Drive. 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. We offer global DCT participant-centric approaches that provide flexibility, meet the most challenging clinical trial demands and provide convenience for patients/caregivers in a compliant manner. 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. We work With HeartTMevery day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. 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. 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. With locations in the US and EU, Catalyst offers highly flexible and customized, customer-centric solutions from Global Resourcing and FSP, to Full Service Managed Solutions, with a focus on oncology product development. An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps. http://www.endpointclinical.com/. As a CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. He is a member of DIA, ARVO and CDISC. Tactical clinical operations in digital health studies, First-hand learnings, breakthrough device system, a case study. She is a Nurse Practitioner by training and spent over 10 years caring for patients before coming to industry. Hear from the trial industry as they discuss the services they would like to see from their solution providers, including: Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. ClinOne, a leader in virtual clinical trial management, provides a single platform technology experience to accelerate clinical trial enrollment and remote patient care, compliance and retention. Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 3rd-4th May 2023! Our Australian phase I facilities are in Melbourne and Brisbane, and our US phase I facility is located in Minneapolis. Evolve our technology to improve the study experience for patients, site, and sponsors with the move towards more decentralized trial models, Software will be more heavily relied upon to keep patients connected, informed, and engaged, Explore the importance of utilizing user-focused research on software design and implementation of eCOA and eConsent in clinical trials, Define the role of leadership in cultivating a Quality and Compliance culture, Establish key considerations for implementation, Explore best practices for ensuring sustainability, Operational analytics including enrollment, protocol compliance and safety, Risk-based analyses and insights with elluminate RBQM, Operational knowledge for data-driven development with elluminate CTMS, Centralized issue management across roles in operations, data and medical review, Sample tracking, data forecasting and financial performance indicators, See how Curebase can design a flexible site model to address specific study concerns, Learn about the features Curebase can incorporate based on Sponsor needs, Witness how virtual sites can be deployed to collect high-quality patient data in real-world settings, Strategies for global patient recruitment, Supplies management and shipping challenges. With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/WRS) expertise at our core, our services are scalable via our strategic partnerships to provide full-service clinical trial solutions that are The Right Fit For You. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone. Meraf Eyassu is a Executive Director of Clinical Operations at Terns Pharmaceuticals. 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. 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. http://www.novotech-cro.com/, To learn more , please visit our website - 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. 5 th Global Pharmacovigilance Summit. Does it offer a solution? Examining how, even as a small company with limited resources you can successfully introduce time and cost saving QMS measures. To learn more , please visit our website - THE 2023 AI UPDATE AI & disruptive technology: Harnessing the future of Artificial Intelligence to transform clinical trials, FIRESIDE CHAT: Overcoming the barriers to trial innovation and technology access from a small companys point of view. Any Device. AI-ML, a Hype or Hope. About Mobile Technologies in Clinical Trials. To learn more , please visit our website - http://www.medable.com/. Anju Software is a customer-first organization providing adaptable life science solutions for clinical research, medical affairs, and data science. Actalent is a leading provider of Clinical and Laboratory services. Practical use cases to improve clinical site efficiency with technology. 28 - 29. Medical Writing and Healthcare Communications Conference. He has been actively involved on both sides of the business in managing CDMOs and CROs. Our performance is built on years of experience staffing the competitive biopharma job recruitment landscape, leveraging our deep networks to source the most highly sought-after candidates in the industry. Rated 4.5 by 2 people. 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. 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. BS in Human and Organizational Behavior, and Communication Studies and authored numerous trade articles and frequently present on behalf of Parexel at trade conferences. What things do they need a partner to do and what they dont need! He is an advisor to several biotech companies. GreenLight Clinical is a physician-led, boutique full-service clinical CRO with its own central clinical, bioanalytical, histopathology laboratories in Sydney, Australia. As a Solutions Consultant with eClinical Solutions, Dan serves as a subject matter expert for the elluminate Clinical Data Cloud, the foundation of digital trials. Clinical Trials Innovation Programme 2023 is the only platform to . She has worked with Calyx for over 7 years as a key strategic leader and director in IRT solutions and services. 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. Were streamlining your research, helping you get to your next milestone faster. To learn more , please visit our website - Global Clinical Trials Connect 2023 2022 London United Kingdom Using modern payment, transportation, and communication solutions we help drive retention, compliance, and data quality. In this presentation we will discuss the following: Clinical development has shifted from a scientifically driven journey to a patient-focused one. WHAT TO EXPECT FOR 2023? To learn more , please visit our website - www.viedoc.com. To enquire about sponsorship opportunities for the conference, please contact: To enquire about speaking opportunities for the conference, please contact: Arena International is a global B2B events company for online casino players. He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. Minimize site activity- could decentralization and Direct-to-Patient trials be the answer to staff shortages? www.emvenio.com, To learn more , please visit our website - 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 . Having worked within all major biopharma markets including USA, Japan, China, EU and Australia has enabled him to become a trusted advisor to many customers and help them achieve their clinical drug development objectives. 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.