Signant Health provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. . www.gobio.com/clinical-research/. I am passionate about the life sciences and the clinical and commercial potential of novel therapeutics and applications of synthetic biology. Meghan McKenzie works in Patient Inclusion and Health Equity in Genentechs Chief Diversity Office. To learn more , please visit our website - Peachtree BioResearch Solutions is an Atlanta-based Clinical Research Organization that provides clinical development support services and innovative resourcing solutions to medical device, pharmaceutical, and biotech companies. Based outside Philadelphia, Pennsylvania, we pride ourselves on being boutique by design and always customer focused. http://www.rhoworld.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. Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. Stream B: Clinical Innovation & Technology, A Fireside Chat on. Vial is a next-generation CRO that leverages the nationwide Vial site network to ensure faster, higher-quality trial outcomes for sponsors. 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 over 22 years of experience overseeing GxP quality and compliance for all phases of drug development for biologics and small molecules. 2023 will see the return of the Clinical Trial Supply Europe conference to Milan where pharma, large and small, alongside biotechs will have the opportunity to discuss, debate and consider new technologies and processes to streamline supply chain operations. Prior to SDCs inception, Richard served on the Board of Directors of Ora, Inc. (www.oraclinical.com) for over 10 years. 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. Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. A significant portion of the cost in a clinical trial can be attributed to operational conduct of the trial such as site monitoring related activities, data management and site oversight. As a service company, our mission is the pursuit of health equity, a focus on diversity and excellence in clinical trial conduct. 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. To collaborate with CISCRP for your upcoming event, please contact Joan Chambers at jchambers@ciscrp.org or Lindsey Elliott at lelliott . To learn more , please visit our website - . Meraf Eyassu is a Executive Director of Clinical Operations at Terns Pharmaceuticals. Outsourcing in Clinical Trials DACH 2022 | 4G Clinical www.zigzagassociates.com. His father was a physician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. The DPO Centre isEuropes leading life science experts, providing Data Protection Officer (DPO) and Data Protection Representative (DPR) services. To learn more , please visit our website - From 2008 to 2011, he was Senior Clinical Trial Manager at Seattle Genetics where he was responsible for the oversight of multiple oncology clinical trials, as well as support for the development of the Clinical Operations infrastructure and regulatory authority marketing approval inspection hosting. Wed, 25 May 2022, 18:00 WebSite. www.medocity.com, To learn more , please visit our website - Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. Worldwide is changing how the world experiences CROs in the best possible way. The Budget Conundrum. Currently a Medical Director/Patient Safety Physician Digital & Devices at Astrazeneca. www.iqvia.com. Novotech is an Australia based clinical CRO operating across Asia and South Africa. Practical use cases to improve clinical site efficiency with technology. atreo.io, To learn more , please visit our website - As a CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. 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. Harbor Clinical, a WBENC-certified, women-owned company, provides a hybrid of services which ensure all aspects of clinical trials meet quality assurance and regulatory standards from study documentation, vendor oversight, and flexible resourcing throughout operations. His drive to improve healthcare is based on passion, compassion and hope. Meet Inspiring Speakers and Experts at our 3000+ Global Events with over 1000+ Conferences, 1000+ Symposiums and 1000+ Workshops on Medical, Pharma, Engineering, Science, Technology and Business. TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. 4240 La Jolla Village Drive. www.tranquilclinicalresearch.com. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. She has a unique perspective in leading clinical programs in a dynamic startup environment. Why having IRT experts involved in your study is important. Many biopharmaceutical trial sponsors rely on or scientific leaders to help design and optimize their protocols and statistical analysis plans. 21 October 2022 Outsourcing In Clinical Trials - Texas 2022. 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. ACM performs more than 20 million laboratory tests each yearspanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more. She has an extensive background including several years of experience in field medical as well as over 6 years in medical affairs. IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. CISCRP staff is committed to participating and presentingspeaker, chairperson, moderator, advisor rolesin relevant and engaging educational events within the clinical research industry. View Event. News; . An opportunity at Gilead Sciences sparked her move to the West Coast, and she is now settled in the San Francisco Bay Area. She intentionally injects laughter and authenticity into everything she does, and is an advocate for kindness, diversity and inclusion, as well as issues impacting women and children. http://www.endpointclinical.com/. 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. Outsourcing in Clinical Trials East Coast 2023 - Arena International Using modern payment, transportation, and communication solutions we help drive retention, compliance, and data quality. 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. We are committed to delivering high-quality, cost-effective services according to sponsor timelines and specifications. Currently he is the CEO of Certum Bio in San Francisco Bay area and honors the co-appointment as the Member of the Board of Advisors, UC Berkeley Postdoc Entrepreneurs Program (BPEP). To learn more , please visit our website - Overview | The Conference Forum Cultural consideration - translations, typical distance from site, etc. 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. LinkedIn Bio: https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/, Enhancing a responsible quality mindset and culture. He also conducted undergraduate research on osteoporosis progression and has authored several papers, abstracts and a book chapter on protein signal transduction. Prior to working at Genentech, she graduated from the Johns Hopkins Bloomberg School of Public Health with a Master of Bioethics. Debashish earned a PhD in Computer Science from the State University of New York at Buffalo, specializing in the application of AI techniques in document analysis. 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. The Global Clinical Trials Connect 2022 will focus on futuristic advancements in the clinical research industry and clinical trials. To learn more , please visit our website - Where do the opportunities lie for further acceleration in clinical development? His current work focuses on deep collaboration with an interdisciplinary team of engineers and scientists to successfully integrate data from multiple assessments and sensors, implement high-dimensional feature engineering, and both evaluate as well as apply scalable machine learning algorithms. AliveCor, Inc. is transforming cardiological care using deep learning. She has extensive experience in building quality organizations, overseeing Phase 3 global clinical trials, supporting marketing authorization applications in the US and EU, and managing pre-approval inspections leading to multiple product approvals and launches. She facilitates policy and procedure development within OMDRHO and collaborates with medical product partners in the Office of Medical Product and Tobacco Operations, and with peers throughout CDRH during daily operations and on special projects. More recently, Arun headed to Santen, with a focus on driving operational excellence in Ophthalmology clinical research as Associate Director Global Clinical Development and Operations, where he oversees Phase 1 4 clinical trial conduct. Triomics is a technology company offering an enterprise-grade platform for clinical trial sites to automate data collection practices. TORONTO, March 23, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions . This holistic self-service platform provides faster data access and intelligent analytics, empowering clinical trial teams to think innovatively. Reimbursement for medical devices in trials, and, understanding the process. Should our biggest concern post-covid be remote working? 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. The global clinical trials outsourcing market size is expected to reach USD 67.62 billion by 2030, according to a new study. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. Clinical Trials 2023. https://www.discoverinternational.com/. Driven by a unique combination of deep domain expertise and technical capabilities, our ClinRun application suite rethinks trial administration through active engagement, smart design, and breakthrough technology. Previous roles within both CRO and Sponsor organizations which provide valuable perspective from both sides of the industry. Our collaborative approach helps maximize efficiency and agility by acting as an experienced member of your team. We have earned a solid reputation around the globe by delivering customized solutions used in over 500 clinical research trials, across 90 different languages in 80 different countries. Our mission is to eliminate the barriers to clinical trials by bringing access to people where they live, work and are willing to engage. SCOPE 2022 attracted more than 2,300 leaders in clinical operations and research and all conference tracks will feature best practice case studies relevant to clinical operations experts and those new to the field. Aug 09 International Conference on Drug Development, Clinical Trial Phases and Technology (ICDDCTPT) - Lagos, Nigeria. Are you planning to attend the upcoming Outsourcing in Clinical Trials New England, November 9-10th, 2021? Wayne holds an MBA and B.S. Join Premier Research at Outsourcing in Clinical Trials Southern California 2022 as it returns for its 9 th annual event. She has worked with Calyx for over 7 years as a key strategic leader and director in IRT solutions and services. . Wendi is currently the Executive Director, Global Medical Affairs Evidence Generation COE at BioMarin Inc. where she oversees global operational strategy and execution for programs in the post-approval setting. We atMyonexadd value to our clients by helping them always be prepared for what is next in their clinical trials. 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. degree in Neurobiology and is the author of several peer-reviewed papers in prostate cancer and premature ovarian failure. He played a pivotal role in the development and commercialization of Veltassa (USA and EU), a treatment for hyperkalemia, Intermezzo for MOTN insomnia, Kerydin for onychomycosis, and Eucrisa for atopic dermatitis. Review market analysis on location of Phase I studies and discuss why these choices are made. Global Clinical Trials Connect 2023 2022 London United Kingdom. Powered by the IQVIA CORE, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. Panellists will address the advantages of DCT; from taking the trial to the patient to boosting recruitment. Electronic clinical outcome assessments (eCOA)and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. https://www.parexel.com/, To learn more , please visit our website - This enables earlier submissions with the potential of coming to market sooner and recovering R&D investments ahead of projections. To learn more , please visit our website - Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences We're here at the Outsourcing in Clinical Trials & Clinical Trial Supply East Asia conference. www.frontagelab.com. Conference series LLC Ltd Organizes 3000+ Global Events Every Year across . We integrate clinical operations excellence, laboratory expertise, and advanced data sciences to deliver on the promise of personalized therapy; translating research into real-world results and forever reimaging how to get there. Learn how elluminate delivers: Empowering excellence in supply through digital quality management systems, In this session our guest speaker will address the challenges with these drugs in development and looking at parallels in a medical device regulatory strategy. Bringing together nearly 700 professionals, TFS delivers tailored clinical research services in more than 40 countries. At Pro-ficiency, Dave has transformed clinical research training into a powerful study resource and analytics tool, and Pro-ficiency has become the leader in the proactive, metric-driven approach to training that contradicts the traditional, check-it-off-the-list approach. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. http://catalystcr.com/. To learn more , please visit our website - www.greenlightclinical.com, To learn more , please visit our website - ClinChoice is a leading full-service clinical CRO offering high-quality solutions to pharmaceutical, biotechnology, medical device and consumer products clients. Despite the ongoing disruptions from COVID-19, 2021 saw some major results from clinical trials. Our intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable hundreds of sponsors and CROs (including all Top 20 pharma) to extend the reach of drug development, expand patient opportunities and improve data quality helping them bring life-changing therapies to our families and communities around the world. ACRP 2023 | April 28 - May 1 | Sheraton Dallas To learn more , please visit our website - Dr Frances Rubenstein has worked in clinical data management for more than 20 years in both medical device and pharmaceutical companies. Focusing on life sciences, Datacubed offers software and services driven by behavioral science to improve patient retention and compliance, resulting in better data and positive health outcomes. From 1990 to 2008 he held various Clinical Operations positions at Abgenix, Pharmacyclics, Quintiles, Covance and Syntex. 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. Boring clinical trials are better clinical trials. Agilex Biolabs operate a fully quality-assured, FDA-inspected laboratory (ISO/IEC17025 and OECD GLP). www.flexdatabases.com. To learn more , please visit our website - After completing her education in England, Ndidi began her career working for Parexel followed by Merck Sharp & Dohme. After 3 years as a patent lawyer at Apple Computer, he took a VP role at startup FormFactor, staying in an IP role, then became the first General Counsel for startup Verisity Design, taking them public in 2001, then ultimately through successful acquisition in 2005. Founded in 1996, ProTrials has been successfully supporting clinical research for over 25 years. Their experienced research team comprises key opinion leaders, board-certified cardiologists and radiologists, sub-specialty scientists, and highly trained technicians who acquire, evaluate, and report high-quality data through an efficient, cloud-based infrastructure. Dr. Arvinder Dhalla has more than twenty years of experience in pharmaceutical R&D, project management, regulatory affairs and clinical development across several therapeutic areas. We work With HeartTMevery day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. Arun Sivanandam has more than 12 years of experience in clinical research at site and sponsor side. February 27, 2023. Actalent is a leading provider of Clinical and Laboratory services. The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Dr. Apfel is a California licensed physician with 20+ years of clinical experience in anesthesiology, critical care medicine, and emergency medicine. 200+. EVENT - DIA Global Pharmacovigilance and Risk Management Strategies Conference. AI-ML, a Hype or Hope. Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. 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. http://www.novotech-cro.com/, To learn more , please visit our website -
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