www.bsi-lifesciences.com. 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. During her career she has advocated for critical partnerships with vendors supporting integration with internal stakeholders. http://catalystcr.com/. Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). 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. GreenLight Clinical is a physician-led, boutique full-service clinical CRO with its own central clinical, bioanalytical, histopathology laboratories in Sydney, Australia. 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. We are an embedded partner dedicated to the success of your study, offering managed services such as: Data Management, On-Demand Data Analytics, Biostatistics, Clinical Management, eTMF Management and Pharmacovigilance. In that role, she built and led the commercial organization that developed go-to-market strategies for Potrero's Accuryn Monitoring System. Meghan serves as the VP, Clinical Trial Financial Management at Medidata driving roadmap and strategy across our Grants Manager and Site Payments products. ClinDatrix, Inc., a CRO, helps pharmaceutical, biotechnology and medical device innovators with clinical projects ranging from Phase I studies to multinational pivotal Phase III trials and post-marketing studies. Partnerships in Clinical Trials Europe 2022. North Carolina, Raleigh-Durham 4 - 5 Apr 2023 . From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. www.medpt.com. 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. With nearly a decade of home visits learnings, Ellen has a unique perspective on how decentralized clinical trials have changed over the years and what the future looks like. PANEL DISCUSSION: Decentralized/Hybrid Trials: Discussing the current challenges and debating best practises for a successful virtual study, Considerations and best practices in direct-to-patient (DTP) / decentralized clinical trials (DCT) lessons learned from past trials, PANEL DISCUSSION: Reversing the Conversation What the clinical trial industry really wants from its service providers, KEYNOTE A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around, A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around. LabConnects unique combination of state-of-the-art technology, world-class laboratories, easy access to emerging markets and extensive specialized testing expertise means the drug development industry can rely on a single provider for all of their central lab needs. pril 28-29, 2016 Dubai, UAE. http://www.labconnectllc.com/. To learn more , please visit our website - The two day, in person conference, Outsourcing in Clinical Trials will deliver top-quality content from industry experts covering all aspects of operational . Catalyst Clinical Research is a new generation Clinical Research Organization, serving the unique needs of small-to-medium sized biopharmaceutical companies. In the life sciences vertical, we help pharmaceutical and medical device companies with clinical trial management, data management, biometrics, medical affairs, regulatory affairs, and quality and compliance initiatives. To learn more , please visit our website - www.pro-ficiency.com. Are you choosing best in class or a bundle? Technology as a methodology: Accelerating Clinical Development timelines. To learn more , please visit our website - Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem. Register. We offer both single modules and a unified solution to maintain all processes you can cover all existing software needs with only one vendor. To learn more , please visit our website - 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. She has a unique perspective in leading clinical programs in a dynamic startup environment. At UCSF he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever. Clinical Trials Conferences | Clinical Trials Meetings | Japan | USA Bringing together nearly 700 professionals, TFS delivers tailored clinical research services in more than 40 countries. Caroline is experienced in the planning and execution of global clinical drug trials in the European, North American, Latin American, and Asia Pacific regions. Clinical Research Organization (CRO) & Biopharmaceutical Services - Parexel Prior to SDCs inception, Richard served on the Board of Directors of Ora, Inc. (www.oraclinical.com) for over 10 years. 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. 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. Outsourcing in Clinical Trials & Clinical Trial Supply Nordics This is the unmissable event that the pharmaceutical, biotechnology, and medical device communities need to come together and discuss strategies for operational success in clinical trials. Learn more atwww.clinone.com. She has extensive experience in leading data management activities for multiregional clinical trials in all phases and several therapeutic areas. Clinical Trials Outsourcing Global Market Report 2022: Rising Our innovative network of Mobile Research Sites, At Home Visits and Technology Enabled Virtual Visits are a unique blend of global DCT capabilities that can be deployed to better reach, recruit and retain diverse patient populations, while improving their clinical trial experience. www.td2inc.com. With presentations and panel discussions on all the hottest industry trends and outsourcing challenges. ARENSIA is trusted by Leading Pharmaceutical and Biotechnology organizations worldwide. Increasing inclusion in future trials for vulnerable populations with health disparities some success stories, Home visits have evolved since their inception in 2003, Services possible in 2023 an overview of what is possible today, Sourcing the right professionals for visits is essential to success, Addressing the reduced site pool challenge and focussing on sites you know can deliver, Overcoming hurdles with imaging centres with reduced staff when trying to qualify patients in a timely manner. Clinical Chemistry & Laboratory Medicine Conference. With this expertise, global scale and the broadest endpoint technology platform, Clario will continue to lead the way in clinical trial technology that will transform patients lives. Joined industry with a goal of developing digital and devices to improve patient care. Partnerships in Clinical Trials Europe editions. Axiom Exhibiting at Outsourcing in Clinical Trials West Coast 2023 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. Can you share some of your workflow procedures? www.viedoc.com. She has driven program strategy and planning, including implementation of 300+ clinical study protocols in 25+ indications, by leading global cross-functional teams towards successful regulatory submissions, product launches, and innovative lifecycle management. 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. Understanding Social Determinants of Health: Identifying the variables that burden trial participants how can we collect this data? Developing successful communication pathways in a more remote world. To learn more , please visit our website - 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. BDO Releases 2022/2023 CRO Insights Report. Clinical Trial Conferences 2023 - mcdougallscientific.com Any Device. 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. Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. DCT was previously done out of necessity but are we seeing it as a new world order? Current topics in the Medical Device Regulatory Landscape, Presented by the FDA. 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. https://www.muralhealth.com/. How do we move forward from here? 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. Conferences. http://www.medpace.com/. Axiom Exhibiting at Outsourcing in Clinical Trials New England 2022 Post doctoral research studies in Human Behavior. Medable offers the most flexible decentralized clinical trial platform streamlining trials for patients, sites, and clinicians whether in-clinic or at home. Heather Kellerman on LinkedIn: Are you attending Outsourcing in 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. To learn more , please visit our website - The news service . 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. Overview | The Conference Forum Outsourcing in Clinical Trials (OCT) Southern California 2022 His expertise is in regulated content management, and he is a member of the TMF Reference Model Project Team. He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. To learn more , please visit our website - Rave RTSM streamlines your operations and provides real-time visibility for your study teams. To learn more , please visit our website - http://www.mlm-labs.com. Learn more at www.iqvia.com. Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. She also has worked within the clinical department at several reputable companies like Axogen, Medtronic, Coloplast and CR Bard. The FDA reportedly rejected Neuralink clinical trials a year ago CHI's 9th Annual Clinical Trial Innovation Summit, November 10-11, 2020, Boston, MA, is multi-track event on best practices needed to optimize clinical trial innovation, planning and management. http://www.iconplc.com/, To learn more , please visit our website - Should our biggest concern post-covid be remote working? Dr. Parapiteva is an experienced regulatory professional with over 24 years in the pharmaceutical industry/clinical research organizations. 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. 21 - 22. This event is a great opportunity to get to know the online casino players who will be [] 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. TORONTO, March 23, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions . Combining patient-reported health data, personal medical records, and conversations in the Inspire community uncovers critical insights unattainable with traditional research methodologies. Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences Kris OBrien is an Executive Director in Program Strategy, specializing in Rare Disease and Pediatrics, at Premier Research. Featuring solutions for automated referrals, eConsent, patient engagement, connected devices, eCOA, and eSource, ClinOne makes participating in a clinical trial a little easier, every day. 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. A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers. To learn more , please visit our website - Parexel Recognized by Frost & Sullivan with 2022 Global Customer Value Leadership Award . 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. Stream B: Clinical Innovation & Technology, A Fireside Chat on. Read more. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. ARENSIA is based with its headquarters in Dsseldorf, Germany, and operates with 400+ talented employees in 7 countries, To learn more , please visit our website - 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 . Were streamlining your research, helping you get to your next milestone faster. Electronic clinical outcome assessments (eCOA)and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. To learn more , please visit our website - http://kpslife.com/. https://www.intrinsequehealth.com/. She has worked with Calyx for over 7 years as a key strategic leader and director in IRT solutions and services. Pharmapack is the European event focal point for the pharma packaging and drug delivery device industry. 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. Jay holds an MBA from Villanova University and a degree in Computer Science and Physics from Gettysburg College. All three clinics are strategically co-located within leading medical, research and biotech precincts offering unique access to ancillary services including bioanalytical laboratories, MRI, lumbar punctures, chest X-rays, ophthalmology assessments and others. PANEL DISCUSSION: Optimizing oversight & governance: What does oversight mean to you? Medables completely modular approach allows pharmaceutical companies and clinical research organizations (CROs) to use only what they want, while scaling capabilities to better suit their unique studies. March. His most recent activity is as CEO and Founder of QuiVivePharma, a company he took from inception to a FDA face-to-face PreIND meeting in just 1 year. Best practices for managing CRO governance for small/start-up companies with limited resources or large companies with competing priorities, Driving success in either unexplored settings or in saturated market settings, Maintaining Chain of Identity/Chain of Custody, Evolving Technologies & Regulatory Guidance documents, Roel of Project Management in helping to drive and streamline cross functional communication, Key considerations for communicating timelines and milestones, Maintaining focus on Quality centric culture, Using machine learning to increase efficiency, Leveraging interoperability to streamline operations. In his role as BD lead, he is responsible for many aspects of the companys planning and operations. To learn more , please visit our website - 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 experts are ready to discuss how our solutions can best support your live studies. Isidora Teodorovi on LinkedIn: I am very excited to be attending News and Events - Ergomed PLC API Services & Chemical Development. In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners. Prior to joining Iovance she served as the VP of Quality at Immune Design which was acquired by Merck. His clinical trial experience spans from set-up to delivery across all phases in a wide variety of disease and therapeutic areas. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric, and rare disease. 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. Top Pharma Events and Biotech Conferences in 2023 | Scilife 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. To learn more , please visit our website - 4G Clinical, a leader in randomization and trial supply management (RTSM) for the global life sciences industry, is sponsoring the 2022 Outsourcing Clinical Trials DACH. 6 th Clinical & Forensic Pathology Conference. Philips BioTel Research is an industry leader in medical imaging and cardiovascular safety testing for clinical trials. Theyll ensure your translations will be of the highest quality, on time, and within budget. Medical Writing and Healthcare Communications Conference. Analytical & Solid State Services. To learn more , please visit our website - Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018. Caroline Cooper is the Director of Clinical Operations at CymaBay Therapeutics, Inc. with over 10 years of experience in clinical research. Clinical Trials Conferences | Meetings 2023 | World BI 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. www.eclinicalsol.com. Our high-caliber project management, clinical monitoring, medical safety, data management, biostatistics, regulatory affairs and quality assurance capabilities make us a valued partner. A visual cognitive neuroscientist by training, Dr. Anderson has over a decade of experience developing both hardware and software to evaluate behavioral and neural mechanisms of attention, working memory, and visual perception. CROMSOURCE is an international contract research organization providing a comprehensive services to the pharmaceutical and biotechnology companies. Outsourcing in Clinical Trials UK and Ireland 2023 Founded and operated as a more customer centric and nimblealternative to traditional CROs, KPS offers a full range of services leveraging the latest clinical technologies. Outsourcing in Clinical Trials Southeast . David Larwood is a founder, the CEO, and chief chemist for Valley Fever Solutions, running the manufacturing process for a novel antifungal headed for Phase 2a trials in 2022. Moving to law, in leading law firms he advised major companies on patent matters. Global Clinical Trials Connect 2023 2022 London United We're here at the Outsourcing in Clinical Trials & Clinical Trial Supply East Asia conference. Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible. Ellen brings decentralized clinical trial visits to patients with PCM Trials experienced Certified Mobile Research Nurses. Be sure to stop by to visit my colleagues at booth #60. We are focused on helping our clients to address their most significant and complex drug discovery and development challenges. Estela has worked in healthcare for over 30 years, currently supporting private practices with electronic medical records, office workflows to help the practice and patients for a top leading healthcare organization. eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. mediantechnologies.com, Medocity is a leading digital health technology company that has been serving the pharmaceutical and life sciences industry for almost a decade. as a Microbiologist, HQ position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import Operations Branch. 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. In 2010, he became a Supervisor Consumer Safety Officer (SCSO). 200+. Agilex Biolabs operate a fully quality-assured, FDA-inspected laboratory (ISO/IEC17025 and OECD GLP). His last company, TheraSim, trained over 1 million physicians worldwide and was sold to WebMD in 2013. 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.
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