This session examines how scientific rigor can be applied to clinical outcome assessments (COAs) even though they are subjective. UPCOMING EVENT. Importance of teams meeting face-to-face so that human touch and team cohesion isnt lost, Setting up rules and expectations creating space for communication, Strategies for prioritising work and tracking milestones with remote teams, Assessing the impact on the trial of remote vs in-person working; how to find a happy medium, How to best leverage remote trial management platforms, How to best utilize critical and non-critical data validation plans, What trial management services are best provided by the sponsor vs. CRO, How to best manage SOW/budget throughout the course of the trial. www.zigzagassociates.com. Founded in 1996, ProTrials has been successfully supporting clinical research for over 25 years. A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers. Outsourcing in Clinical Trials Europe 2023 - Arena International She has a unique perspective in leading clinical programs in a dynamic startup environment. Are you attending Outsourcing in Clinical Trials West 2023 conference? To learn more , please visit our website - 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. Read more. To learn more , please visit our website - Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. During her career she has supported Class 1-3 devices through the entire product lifecycle. To learn more , please visit our website - It is a 2 day event organised by Arena International Events Group and will conclude on 30-Nov-2022. At Strategikon Pharma, we bring a high level of precision and speed to outsourced clinical trial operations through our flagship SaaS platform, Clinical Maestro. Technology as a methodology: Accelerating Clinical Development timelines. The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. 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. Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Casimir's research on the development of the Duchenne Video Assessment (DVA) scorecards was published in PLOS ONE. He is also President of SBS Medical Management, a healthcare economic consulting firm for investment banks and Expert Medical Reviews, including the California Medical Board. Combined, our clinics offer over 200 beds. Experienced in research methodologies and conducting qualitative and quantitative research in a variety of therapy areas including respiratory, cardiology, oncology, immunology rare diseases and emerging therapy areas. Choose from over 15 fully integrated modules on a single platform: EDC, DM, RTSM/IWRS, CTMS, Inventory Management, ePRO, eConsent, Patient Portal, AE/SAE Tracking, Safety Database, Central/Local Lab, Imaging Management, eTMF, and 24/7 Project and Clinical Data Reporting. We have expanded our product line to include Medical Device Labeling through AWT Labels & Packaging. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve live. She has held key national leadership roles including advisor within the Obama/Biden administrations global HIV response team, advisor to United Nations leadership and instructor at the CDC and USAID. Estela has supported her sister and her passion to help others has evolved to iLOOMinating, Engaging, Empowering and Supporting the community as a whole to take control of their healthcare. Clinical Research Organization (CRO) & Biopharmaceutical Services - Parexel Outsourcing in Clinical Trials Southeast . WORKSHOP: Identifying and overcoming the hurdles associated with global studies including longer timelines, drawn-out budgets and remote teams. For more than 30 years, Rho has been a trusted partner to leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. To learn more , please visit our website - Kumar earned his Ph.D. from the University of Vermont and was a post-doctoral fellow at the University of Virginia. 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. Clinical Trials Conferences | Clinical Trials Meetings | Japan | USA Outsourcing In Clinical Trials East Coast 2022. She develops strategies to drive greater inclusion of racial and ethnically representative patient populations in clinical research and to advance health equity Gaining patient, clinician and community insights early in program development is integral to developing what is important to patients and improving access to medicines and treatments for all patients, regardless of race, ethnicity, sexual orientation, gender identity, age, socioeconomic status and ability/disability. Prioritizing patient diversity. Jay holds an MBA from Villanova University and a degree in Computer Science and Physics from Gettysburg College. Harness the power of video evidence in clinical trials with ChilliPharms compliant platform and suite of video services for filming, de-identifying and reviewing clinical outcome assessments. 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. 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. 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. 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. Taking a Data Science approach to gain financial oversight of clinical trials. http://www.premier-research.com/, To learn more , please visit our website - To learn more , please visit our website - 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. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. 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. We provide a comprehensive digital solution for Ph 1-4 studies with enterprise-level capability that is configurable to be fit for purpose to support biopharmaceutical companies, CROs and research sites. Arun received a Bachelors degree in Biological Sciences from University of California-Riverside, a Masters degree in Biomedical Sciences from Wayne State University and completed Doctoral degree coursework from Michigan State University College of Human Medicine. San Diego Marriott La Jolla. 6 th Clinical & Forensic Pathology Conference. 2022 looks to be a bumper year too, so Nature Medicine asks leaders in their field what they think . 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). Can you share some of your workflow procedures? 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. 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. For more information, please contact us at 262-334-6020, or via email at Daniel.Selness@spauldingclinical.com. Why expert partners and staff matter; what metrics dont tell. Debashish has over 18 years of experience in the life sciences / clinical trials industry, including several leadership roles in Product Management. She is currently managing a Ph3 program in rare liver disease. ICACB 2023: Applied Clinical Biostatistics Conference, Rio de Janeiro (Feb 16-17, 2023) ICAHIPHIM 2023: Advanced Healthcare Informatics and Public Health Informatics Management Conference, New York (Feb 16-17, 2023) ICCPP 2023: Clinical Psychiatry and Psychology Conference, Barcelona (Feb 16-17, 2023) ICEPNR 2023: Exercises for Pediatric . Outsourcing In Clinical Trials East Coast 2022 - HealthManagement.org What are global biotech executives asking/concerned about when evaluating Phase I study plans? PANEL DISCUSSION: The concept of DCT, is it the future? Frances has an undergraduate degree in Physiology and a PhD in medical science from the University of Sydney. He worked as a Research Associate to improve recruitment metrics in the Million Veterans Program genomic biobanking initiative for Loma Linda VA Medical Center where he developed a novel Point of Care recruitment solution in outpatient clinics. Any Device. Analytical & Solid State Services. Combining OCT, CTS and Medical Devices events, this is the perfect platform for professionals from . February 27, 2023. Dr Frances Rubenstein has worked in clinical data management for more than 20 years in both medical device and pharmaceutical companies. 30+. The therapeutic areas include: Cancer, CV, CNS and infectious diseases. Despite the ongoing disruptions from COVID-19, 2021 saw some major results from clinical trials. In this presentation we will discuss the following: Clinical development has shifted from a scientifically driven journey to a patient-focused one. To learn more , please visit our website - He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv. https://www.trilogywriting.com/. Learn more atwww.clinone.com. Review and assess the selection criteria sponsors face when selecting Phase I jurisdiction. http://www.clindatrix.com/. As the worlds largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. The global clinical trials outsourcing market size is expected to reach USD 67.62 billion by 2030, according to a new study. Clincierge reduces barriers to trial participation by employing patient-centric strategies to enhance the patient experience, increase patient retention, and improve clinical trial performance. To learn more , please visit our website - http://www.spauldingclinical.com/, To learn more , please visit our website - Elon Musk's Neuralink sought FDA permission in early 2022 for human clinical trials of its brain-computer interface and received an application rejection, Reuters reports. Conversis is built on one goal: To provide you with the highest-quality clinical trials translations. Who we are; From 7 to 9 November 2022. Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. To learn more , please visit our website - Spaulding Clinical operates a 200-bed Clinical Pharmacology Unit, a Full Service Biometrics Group and Cardiac Core Laboratory. Our specialized experts drive scale, innovation, and speed to market for visionary clients around the world. Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible. https://www.intrinsequehealth.com/. Wayne holds an MBA and B.S. Liza Melchor-Khan is a Senior Director of Clinical Operations at NGM Biopharmaceuticals, Inc. with over 25 years of experience in the biotech and pharmaceutical industry. Anju is a portfolio company of Abry Partners serving the worldwide pharmaceutical, biotech and contract research Life Sciences markets. Brandi Coffin has been in the medical device industry for over 15 years with various roles in post market surveillance, quality, compliance and patient safety. Drug development Conferences | Meetings | Events | Symposiums I am very excited to be attending Clinical Outsourcing Group UK this year in London! Login; Register now; Toggle navigation. Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORAs Office of Import Operations. Drivers of failures, Flawed clinical study design leading to failures, Diagnostic indicators and early Go/No-Go decisions in proceeding further during clinical study phases. Clinical Trials Innovation Programme 2023 is the only platform to . 8th Edition of Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PHARMA 2023) Mon, 13 . 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. www.saama.com. Medidata is leading the digital transformation of life science, with the worlds most used platform for clinical development, commercial, and real-world data. It was through this privileged relationship with patients facing devastating diagnoses that Meghan witnessed first hand the life-saving and life-enhancing effects of medical and therapeutic intervention thus piquing her interest in the drug development process. Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. May 3 - May 4 @ Barcelona, Spain. Practical use cases to improve clinical site efficiency with technology. 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. The Association of Clinical Research Professionals (ACRP) supports clinical research professionals through membership, training and development, and certification. Please email me if you'd like to set up a meeting to discuss your upcoming clinical trials: Fusion eClinical Suite is the most adaptable, unified platform that serves as the Connected Hub for all your Clinical Trial and operational data and reporting. Flex Databases platform is a secure, unified and compliant system for clinical trials. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. To learn more , please visit our website - Prior to TransPerfect, Jay directed teams on moving several enterprise product platforms to the cloud at Medidata and Sparta Systems. Wed, 25 May 2022, 18:00 WebSite. Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. http://www.rhoworld.com/. Theyll ensure your translations will be of the highest quality, on time, and within budget. Outsourcing in Clinical Trials DACH 2022 | 4G Clinical Founded in 1976, ACRP is a Washington, DC-based non-profit organization with more than 13,000 members who work in clinical research in more than 70 countries. Phase 1 Trials: How to globalize to accelerate value inflection. To learn more , please visit our website - 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. http://www.augustresearch.com/. Bioethics, regulations, patient recruitment, site selection, real-world data, data integration & Strategy, outsourcing, vendor management, quality (QbD) in Trial Conduct, risk-based . Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences clinical trials Conferences 2023/2024/2025 is for the researchers, scientists, scholars, engineers, academic, scientific and university practitioners to present research activities that might want to attend events, meetings, seminars, congresses, workshops, summit, and symposiums. Our simulation-based protocol training prevents study errors, guarantees timely SIV, and frees up thousands of hours for your study team and site-staff. Outsourcing in Clinical Trials Southern California 2022. 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. 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. I will be there with my colleague Georgi Govedarov, come visit us at booth Isidora Teodorovi on LinkedIn: I am very excited to be attending Clinical Outsourcing Group UK this year 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. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals. To collaborate with CISCRP for your upcoming event, please contact Joan Chambers at jchambers@ciscrp.org or Lindsey Elliott at lelliott . Advarra advances the way clinical trials is conducted to make them safer, smarter, and faster. Also within Genentech, she is a core member of the Advancing Inclusive Research Site Alliance and leads the company's LGBTQ+ Health equity strategies. Weve all had to sit through several pitches from vendor companies telling us what they can do for us, but now its time to reverse the conversation! Digital Technology in Clinical Trials - DIA Global IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. To learn more , please visit our website - http://www.datacubed.com/. The main program of the conference is discussion and debate on the outsourcing of clinical research. OCT DACH Conference 2022 - Outsourcing in Clinical Trials. Orbis Clinical is a leading global life science recruitment partner. ), pharmacovigilance and safety solutions, translation and language services, and call center support. 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. 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. http://catalystcr.com/. Kunal has over 18 years of experience managing and conducting clinical trials. We offer customized solutions to fit the needs of each study, patient and site, making it easier for your patients to stick with it. To learn more , please visit our website - Greenphire is the industry leader of clinical payment technology, designed to improve the way research professionals work. Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc. https://www.worldwide.com, To learn more , please visit our website - What is critical to get right to make a digital QM System work? To learn more , please visit our website - www.Clario.com. http://www.kpslife.com. www.allucent.com. In addition to her deep understanding of the unique dynamics of developing novel treatments for rare and complex diseases, Dr. Raymond also leverages her combination of training and experience leading the Gene Therapy Think Tank at Worldwide Clinical Trials. Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. 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. 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. Improving communication, relationships and work-life balance with your internal team as well as partners. http://citlabels.com/. 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. Employee turnover continues to impact global market for talent. THREADs platform and supporting services are helping customers to shorten study launch timelines, reduce study budgets with Virtual Visits, and bring studies from the clinic to patients homes. 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 Budget Conundrum. 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. Viroclinics-DDL, a Cerba Research Company is a leading specialty contract research organization, serving the biopharmaceutical community with a broad range of non-clinical research, clinical diagnostics, assay development, laboratory, and clinical trial logistic services. Add the event to your calendar. Outsourcing in Clinical Trials Europe 2023. Currently, Audrey Funwie works in the Patient Inclusion and Health Equity team of Genentechs Chief Diversity Office. 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.