Are you attending Outsourcing in Clinical Trials West 2023 conference? 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. PANEL DISCUSSION THE PATIENT IMPACT: Patient recruitment, patient centricity & virtual trials Navigating the New Normal, QUICK FIRE ROUNDS: The Patient Perspective, Keynote Not just ticking a box: Outreach to minority groups is improving but the focus now is on establishing trust and relationships. 2023 edition of Outsourcing in Clinical Trials East Coast will be held at King of Prussia starting on 23rd May. Booth #4. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. 2023. Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders. Helping you take advantage of the speed of study start-up and R&D tax incentives in Australia and allow for smooth trial transition in the US. Outsourcing in Clinical Trials Southern California 2022. She is acknowledged for her expertise and passion in Data Integrity and Vendor Oversight, and has been recognized as a thought leader in process optimization and standardization as they relate to Inspection Readiness. 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. To learn more , please visit our website - The 2023 programme will offer a fresh insight into the latest regulatory updates, global clinical trials, advanced technologies such as digital health and connected devices space, and more. TICKETED. Passionate about novel tech-enabled medical devices that advance the understanding and treatment of diseases. In his role as BD lead, he is responsible for many aspects of the companys planning and operations. An international speaker, Dr. Hughes is responsible for a team of scientific experts who provide guidance and analysis services related to the creation of electronic data collection systems for clinical trials. Anju Software is a customer-first organization providing adaptable life science solutions for clinical research, medical affairs, and data science. As Vice President, Business Development at Curebase, Wayne leverages more than a decade of experience in clinical research across both clinical operations and strategic sales to identify new areas for growth within the company. Pharmapack is the European event focal point for the pharma packaging and drug delivery device industry. http://www.altasciences.com/, To support the acceleration of drug development, over the last 12 years, ARENSIA Exploratory Medicine GmbH (www.arensia-em.com) has built up its own research clinics, with full Phase I infrastructure, entirely dedicated to the performance of sophisticated FIRST-in-PATIENT Phase IB, IIA and PROOF OF CONCEPT clinical trials with novel compounds. We atMyonexadd value to our clients by helping them always be prepared for what is next in their clinical trials. Key changes for the implementation of the EU CTR, Preparation for the EU CTR implementation, Submission efficiencies when using a CRO in the EU, Exploring how to introduce a new digital quality compliance management system. 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. KPS is a global, innovative, Clinical Outsourcing Provider delivering clinical trial monitoring, management and quality oversight services to pharmaceutical, biotechnology, medical device, and related industries. She is definitely not afraid of being the least popular girl in the room in order to support patient safety! The DPO Centre has assisted over 600 clients globally, including a broad range of bioscience, genomics, therapeutics, healthcare and pharma companies to comply with EU data protection laws such as the GDPR, the EU Clinical Trials Regulation and specific member state requirements. Care Access is a global research site that accelerates the availability of new treatments and therapies through our unique site infrastructure and ability to cultivate research-empowered communities. http://www.heartcorsolutions.com. Join thought leaders from regulatory agencies, biotech, pharma, patients, and academia to discuss the latest advances, challenges, and forward-thinking . Founded in 1996, ProTrials has been successfully supporting clinical research for over 25 years. An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps. Our customized and scalable solutions improve the quality and execution of clinical trials while mitigating costs and allowing clients to retain strategic control. www.emmes.com, Emvenio Research is a leading decentralized research organization (DRO) providing scalable and hybrid decentralized trial solutions improving clinical trial access to underserved and high-risk populations. Date: January 18 - February 17, 2023. Since 2003, Conversis has supported our life sciences clients to successfully and effectively communicate with patients and medical professionals worldwide. Understanding Social Determinants of Health: Identifying the variables that burden trial participants how can we collect this data? Panellists will discuss the challenges and tech barriers with DCT. 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. Our scientific knowledge base, technical expertise and reputation for high quality services have been integral to our ability to turn our services into your solutions. To learn more , please visit our website - With over 15 years experience in the industry, Esther has predominantly worked in clinical trial management and data management roles across Europe, North America and South Africa. 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. 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. KPS Life (www.kpslife.com) is a stand-alone, global functional service provider (FSP) that offers a clinical outsourcing solution across all phases of clinical drug development. 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. Conference . March 14 . 85356 Mnchen-Flughafen , Join NAMSA 5-6 April in Munich, Germany for Outsourcing in Clinical Trials: Medical Devices Europe. She has led clinical development in dermatology and medical aesthetics for pharma/biotech, CROs, medical device and cosmetic companies including RAPT, Innovaderm, Premier Research, Allergan, Leo Pharma, and Murad. https://medrio.com/, To learn more , please visit our website - 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. Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideasinto reality. www.viroclinics.com. Dr. Cunningham came from academic background. www.prevailinfoworks.com. My training is in genetics (Ph.D.) and mechanical/biochemical engineering (M.S. This enables earlier submissions with the potential of coming to market sooner and recovering R&D investments ahead of projections. Meghan joined a CNS-focused start up in RTP and has spent the last 15+ years working in the life science technology industry. With an agenda covering the future of Clinical trials, patient centricity, digitalization and drug development post COVID, Clinical Trials Innovation Programme 2023 will feature tailored sessions presented by the leading experts and service providers from across the globe. 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. Practical use cases to improve clinical site efficiency with technology. He works cooperatively and collaborates with Federal, State, and local agencies to ensure appropriate consumer protection. RadMD, a Medica Group Company, is your full service imaging core lab solution. Diagnostic Services. https://www.nucleusnetwork.com/au/, To learn more , please visit our website - Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. 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. Explore and learn more about Conference Series : World's leading Event Organizer. 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. MedPoint Digital develops intuitive, ICH-GCP compliant eClinical platforms for virtual investigator meetings, trial portals, interactive modules, and virtual clinical trials. The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. Estela Mata is the President and co-founder of Looms for Lupus, a non-profit organization that provides Lupus, Fibromyalgia and Mental Health Awareness, advocacy, and support to those living with these conditions, their loved ones, and caregivers. 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. Novotech is an Australia based clinical CRO operating across Asia and South Africa. Finding patients is a challenge. Kristina leads the Patient Insights team at Parexel and is dedicated to bringing a thorough understanding of the patient journey, and the patient voice to the entire spectrum of research services. Advantages of working alongside grass root organisations and PAGs what groups are out there? With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact by driving quality, mitigating compliance risk, and enhancing patient engagement. Why drugs fail in clinical trials? He is an advisor to several biotech companies. Chris deep knowledge of the global early phase drug development industry strengthens the tradition of success of Nucleus Network, our customers and partners in Advancing Medicines, Improving Lives. Minimize site activity- could decentralization and Direct-to-Patient trials be the answer to staff shortages? She is currently the Founder and CEO of Strategikon Pharma, developer ofClinical MaestroTM, the industrys only end-to-end cloud-based platform for clinical trial budgeting, sourcing and budget management including strategic alliance/partnership management. Recognising how Social Determinants of Health contribute to outcomes in disease, Assessing which communities you arent successfully recruiting from and exploring data to understand why, Focussing on education in this space and what we can all do moving forward. 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. 200+. Myonexis a global complete clinical trial solutions provider. Actalent is a leading provider of Clinical and Laboratory services. 6 th Clinical & Forensic Pathology Conference. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services. Promedica International is a privately held, full-service CRO providing clinical trial services for the medical device, biotechnology and pharmaceutical industries. North Carolina, Raleigh-Durham 4 - 5 Apr 2023 . . Formed through the merger of IMS Health and Quintiles, IQVIA has more than 58,000 employees worldwide. Frontageis a CRO providing integrated, scientifically-driven research, analytical and product development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals. 5 th Global Pharmacovigilance Summit. Precision for Medicine (PFM), the full-service global CRO, is purpose-built to accelerate clinical research and development processes to bring life-changing therapeutics to those who need them most. Together with our client partners, we are fulfilling our purpose of Advancing medicine, improving lives., To learn more , please visit our website - https://www.nucleusnetwork.com/au/. This conference will explore the latest regulatory updates, global clinical trials, advanced technologies and more. Tickets. We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. She has a unique perspective in leading clinical programs in a dynamic startup environment. Worldwide is changing how the world experiences CROs in the best possible way. http://www.cromsource.com/. Prior to this position he was the Division Director for the Division of West Coast Imports since February 9, 2018. Before joining Curebase, Wayne served as Vice President at mid-sized Florida based CRO Biorasi, where he helped to lead that company to a successful acquisition by a private equity partner in 2018. To learn more , please visit our website - 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. 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. Arena International are delighted to announce the Outsourcing in Clinical Trials Southern California Event will be returning to California's La Jolla on September 26th & 27th 2023! Kunal has over 18 years of experience managing and conducting clinical trials. 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. Alton Sartor completed a combined MD/MBA from Tulane University. To learn more , please visit our website - Our leading clinical show will focus on providing delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials, this is an [] Communities. In partnership with customers, we build solution-driven teams working for a healthier future. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018. 30+. Earlier as a bench chemist, he was the first to make Iotrolan, a CT X-ray contrast agent, generic for decades, replaced in about 2005 by newer agents. Arena International are delighted to announceOutsourcing in Clinical Trials West Coastwill be returning to Burlingame for the annual event onMarch 1st& 2nd2023! She then ventured across the pond to the United States where she worked for Novartis, Pfizer, Johnson & Johnson and Aeras (one of the Bill Gates Foundation companies specializing in TB and Malaria). The 15th annual conference will provide experts in the life science industry to connect and explore solutions to current operational and outsourcing challenges associated with clinical trials . With a dual clinical appointment in Robotic-Surgery at the Institute, Arun focused on post-surgical outcomes of Da-Vinci Robotic Prostatectomy for Hormone Refractory Patients. 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. Company Website:https://eurofinscentrallaboratory.com/biopharma-services/, To learn more , please visit our website - Developing successful communication pathways in a more remote world. 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. Previously she served as Head of Clinical Outsourcing and Analytics for BioMarin Pharmaceuticals, where she was responsible for vendor contractual, relationship and financial management. www.myonex.com. Five gene therapy trial readouts to watch in the first half of 2023 New Omicron variant could threaten vulnerable people this winter Inclusive drugs: designing clinical trials for the pregnant population Estela is an exceptional community engagement liaison for both English and Spanish speakers. Should our biggest concern post-covid be remote working? Philips BioTel Research is an industry leader in medical imaging and cardiovascular safety testing for clinical trials. Session Reserved for Worldwide Clinical Trials, Data Management: Programming and metrics in medical device studies, Vast experience of over 20 years in Quality, Regulatory, Processes Improvements and leading cross organization projects, VP Quality Assurance, Regulatory Affairs and Clinical at IceCure Medical, since September 2020, leading the company compliance and clinical affairs, Prior to joining IceCure Medical, held a position of Director of Quality, Regulatory and Customer Support at Applied Spectral Imaging (ASI) and Several positions at Carestream Health (formerly Orex Computed Radiography). Complimentary. The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. She is a career FDA federal service veteran with vast experience in technical and managerial positions across multiple commodities. Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. Dr. Marszewska earned her MSc and PhD degrees in the field of chemistry. Erin has over 20 years of clinical trial and pharmaceutical software technology experience . His thesis was on the role of the Androgen Receptor in Hormone Refractory Prostate Cancer. Partnerships in Clinical Trials Europe editions. Compare and contrast the FDA, MHRA and TGA regulatory requirements for Phase I clinical entry. What is critical to get right to make a digital QM System work? Topics: For over 35 years Parexel has been a trusted global clinical research organization (CRO) and biopharmaceutical services company. Outsourcing Clinical Trials New England 2022. Clincierge reduces barriers to trial participation by employing patient-centric strategies to enhance the patient experience, increase patient retention, and improve clinical trial performance. Dr. Marszewska has experience with electronic data capture and data management in clinical research. Ms. OBrien has been conducting clinical research for more than 35 years and has covered multiple functions during that time. This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. How do you arrange with and clean the large amounts of data generated? INTERACTIVE SESSION: Establishing and maintaining strong CRO/sponsor relationships and building trust in a more virtual landscapeWhat have we learned and what should we focus on? 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. For the 13 th Annual event, our flagship European clinical show will provide delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials . She has over 22 years of experience overseeing GxP quality and compliance for all phases of drug development for biologics and small molecules. There, he employed a broad range of methodologies, including: visual psychophysics, neuropsychological and computer-based cognitive assessments, eye tracking, electrophysiology, and structural imaging. Triomics is a technology company offering an enterprise-grade platform for clinical trial sites to automate data collection practices. The 2014 event will focus on how companies from the region can implement effective clinical outsourcing strategies. Clinical Outcome Assessments (COAs): Applying scientific rigor and good instrument design. http://www.protrials.com/. in Electrical Engineering & Computer Science from UC Berkeley and Ph.D. in Biological & Medical Informatics from UCSF. To learn more , please visit our website - ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. Reem holds a PhD in genetics from the Hebrew University of Jerusalem. Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. ARENSIA is trusted by Leading Pharmaceutical and Biotechnology organizations worldwide. With her unique blend of business acumen and technical expertise, Rebecca Lin is a dynamic leader with many years of success in the healthcare industry. 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