How best to go about educating the patient community? Read more . 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. 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). Interactive Response Technologies (IRT) 2022 brings the clinical community together to discuss cutting-edge updates in technology and dives into strategies to help the clinical industry excel in their trials and data management. To learn more , please visit our website - To learn more , please visit our website - Francis has lead supplier oversight responsibilities for sponsors, CROs and clinical system vendors. As an international key opinion leader in dermatology clinical development, Dr. Jankicevic has served as advisor to multiple companies on their path to global regulatory and commercial success. Clinical Outcome Assessments (COAs): Applying scientific rigor and good instrument design. www.prevailinfoworks.com. From 1990 to 2008 he held various Clinical Operations positions at Abgenix, Pharmacyclics, Quintiles, Covance and Syntex. The last decade of this time has been solely focused on the investigator grant administration domain driving strategy and leading teams implementing payment technology in both BPO and enablement models. Developing and supporting your quality initiatives from Day 1, the Harbor team is committed to quality through each functional service we provide. Or has the noise around DCT quietened? 11 th International Conference on Clinical Trials is scheduled to be held during November 09-10, 2023 at London, UK. His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever. Clinical Trials 2022 will discuss various disciplines involved in the pre-clinical research, conduct of clinical trials; it will educate health care researchers about design, operation, organizing, research computing . FDAs role in maintaining a secure and resilient supply chain. 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. Why should we collect Sexual Orientation and Gender Identity in Clinical Research Studies? This Clinical Trials Conference includes a wide range of Keynote presentations, Plenary talks, Symposia, Workshops, Exhibitions, Poster presentations and Career development programs. To learn more , please visit our website - Sun, 24 Apr 2022, 09:00 End. 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. DSG, Inc. celebrates over 25 years as a leading global eClinical provider with a fully integrated suite of innovative technology solutions and data management services: Award-winning eCaseLink EDC & DSG Designer for Enterprise licensing with CDISC standards; Risk-Based Monitoring, eSource, IWRS Randomization and Clinical Supply, Drug Safety, Patient Profiles, ePRO, CTMS, Site Payment, Protocol Violations, ad-hoc reporting, CDM services, and digital on-demand Clinical Printing services. Pharmapack is the European event focal point for the pharma packaging and drug delivery device industry. Learn more atwww.clinone.com. Brandi has participated in numerous regulatory inspections as the Management representative, authored HHEs for all levels of products and issues and prides herself on being a patient advocate. www.viedoc.com. 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. AliveCor is a privately-held company headquartered in Mountain View, Calif. Consumer or Personal ECGs are ECG devices available for direct sale to consumers. Outsourcing Clinical Trials New England 2022. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience. She is also a Certified Clinical Research Professional, and a trained journalist. To learn more , please visit our website - http://www.premier-research.com/, To learn more , please visit our website - 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. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. 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. Practiced Neuro-Oncology and General Neurology at the VA and Boston Medical Center. This experience includes in vivo viral- vectored gene therapies, ex-vivo viral vectored and gene edited treatments for oncology and non-oncology patient communities, and RNA medicine modalities. Please email me if you'd like to set up a meeting to discuss your upcoming clinical trials: Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionalscollaborateswith biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. www.ACMGlobalLab.com. Vice President, CMC and Supply Chain, Union Therapeutics, Umar Hayat, Ph.D. is VP of CMC and Supply Chain at Union Therapeutics and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. Bruce earned his doctorate in biochemistry from UCLA and completed a postdoctoral fellowship at the University of California Berkeley. Erin has over 20 years of clinical trial and pharmaceutical software technology experience . www.tprausa.com. He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. Electronic clinical outcome assessments (eCOA)and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. We go beyond traditional events and offer, The main program of the conference is discussion and debate on the outsourcing of clinical research. https://www.propharmagroup.com/. www.eclinicalsol.com. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. To learn more , please visit our website - The Decentralized Clinical Trials hybrid event, April 18th - 20th in Boston, will provide leading insights and practical guidance on how to decentralize your clinical trials for greater diversity, accessibility and efficiency, with guidance a world-class speaker line up. We develop new innovations, drive emerging therapies forward and improve patient lives. eurofinscentrallaboratory.com/biopharma-services. Contact: ESMO Registration Office; Phone: [+41 (0) 91 973 19 13]; Email: registration@esmo.org. 3 rd Clinical Pharmacy Conference. 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. Strategy/Planning: How do you make the decision to run a DCT; what are the considerations? This is also a critical time to determine the development strategy for later study phases. Each year, we bring forward the latest experience . To learn more , please visit our website - 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 standard products and services include patient recruitment, eConsent, ePRO/eCOA, interactive digital support and symptom monitoring with the capability to provide an end to end clinical to commercial solution. Our experts are ready to discuss how our solutions can best support your live studies. http://www.arensia-em.com/. 12 years at Parexel. Day 1 will kick off with a talk on designinga playbook for how to handle an undesirable CRO-Sponsor partnership, followed by a Keynote Panel allowing attendees to debate how to optimize theiroversight & governance, led byAbby Kennedy(VP of Clinical Operations, CymaBay Therapeutics). Dr. Apfel is also the Chair of Life Sciences at the Keiretsu Angel Investment Forum, where he invests in life-science companies that have the potential to positively impact patients with serious conditions. We do this by combining our 25 years of proven quality and results with expertise in 30+ therapeutic areas, a flexible approach, and dedicated teams who enable rapid startups and fast timelines. Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem. http://citlabels.com/. He has been a visiting professor at Catholic U., Louvain, Belgium and U. Pittsburgh, Pittsburgh, PA and visiting speaker at Humboldt U. in Berlin, Germany. Clinical ink is the global life science company that brings data, technology, and patient science together. Our experienced team has been in this niche of clinical research with deep domain experience for decades and client solutions has been our passion for over two decades. She leads the scientific development of digital clinical measures and the modernization of clinical development models under the banner Technology As Methodology. 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. She became the Deputy Program Director for OMDRHO in 2017 and ultimately became OMDRHO Program Director in February 2022. She has a wealth of knowledge and experience having served more than 24 years in ORA managing staff and operations focused on medical devices, radiological health, and MQSA. November 28-30, 2016 San Antonio, USA. The Digital Transformation of Clinical Trials the Importance of Data Accuracy. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. in Electrical Engineering & Computer Science from UC Berkeley and Ph.D. in Biological & Medical Informatics from UCSF. Tranquil Clinical Research is an early phase CRO with a fully accredited Hospital Phase I unit. To learn more , please visit our website - 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. Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. Since 2003, Conversis has supported our life sciences clients to successfully and effectively communicate with patients and medical professionals worldwide. WORKSHOP: Identifying and overcoming the hurdles associated with global studies including longer timelines, drawn-out budgets and remote teams. Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. 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. May 3 - May 4 @ Barcelona, Spain. Chris has dedicated his 16-year career to the services side of the Phase I clinical drug development industry, including both operational and business development roles. August, 2023. Q2 Solutions is a leading global clinical trials laboratory services organization that helps biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. He started his career with FDA in 1998. 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. 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). To learn more , please visit our website - 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. Henry earned his B.S. Dr. Apfel is a California licensed physician with 20+ years of clinical experience in anesthesiology, critical care medicine, and emergency medicine. 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. To learn more , please visit our website - 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. During her career she has supported Class 1-3 devices through the entire product lifecycle. Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. To learn more , please visit our website - https://www.threadresearch.com/. DGE invites you to return to the industry's first, most detailed, and most trusted conference on this topic - our 7th Decentralized & Hybrid Clinical Trials Summit. 2023. Mural Health is a participant management platform that helps manage & streamline the trial experience for patients and caregivers. 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. Altasciences full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, data management and more, all of which can be tailored to specific sponsor requirements. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine. 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. www.clincierge.com. Were a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. 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. To learn more , please visit our website - The Patient Engagement track will be chaired byEstela Mata-Carcamo(Healthcare Advocate) and will delve into topics such as,outreach to minority groups,social determinants of health, and best practices forengaging the patient community. 10th International Conference on Clinical Trials is scheduled to be held during August 04-05, 2022 at Vancouver, Canada. To learn more , please visit our website - https://www.worldwide.com. www.saama.com. She is a Registered Respiratory Therapist, holds the CPPS (Certified Professional in Patient Safety) credential from IHI and has a Masters degree from Johns Hopkins in Patient Safety and Healthcare Quality. TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. medtech.labcorp.com. With deep expertise in clinical development and more than 25 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day. Outsourcing in Clinical Trials Europe 2023. We help teams bring order, trust, and predictability to protocol execution and automation. Europe's leading clinical trials conference focusing on partnerships, outsourcing, operations and technology is now In-person event. His last company, TheraSim, trained over 1 million physicians worldwide and was sold to WebMD in 2013. Since 2000, Anne has held supervisory and branch director positions. . 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 . We are committed to delivering high-quality, cost-effective services according to sponsor timelines and specifications. Currently, Arvinder is VP of Clinical Development at Rani Therapeutics, where she is responsible for Clinical and Regulatory functions for all programs. Wayne resides in Miami, Florida. in Psychology and Biology from the University of California at Santa Cruz. Topics: http://www.mlm-labs.com. The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. 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. www.orbisclinical.com. www.kardia.com. Parexel Recognized by Frost & Sullivan with 2022 Global Customer Value Leadership Award . Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc. To learn more , please visit our website - 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. To learn more , please visit our website - https://www.anjusoftware.com/. Join us in Philadelphia, May 10th-11th, to shape best practice on: Refining patient recruitment strategy. 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. Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. 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. Mr. Larwood is the third of his family to be involved in Valley Fever. She has over 25 years of clinical development experience working at sites and in industry, and spanning multiple diseases, including oncology, ophthalmology, immunology, neurology, infectious and rare diseases. Add the event to your calendar. 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. I am very excited to be attending Clinical Outsourcing Group UK this year in London! Advance Research Associates is a premier provider of biostatistical and data management services to the pharmaceutical, biotech, and medical device industries. 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. 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. To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv. Operating in 49 countries across the globe, KPS Life is committed to working together with its clients through a hands-on operating model rooted in a partnership approach. 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. 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. February 27, 2023. Embedding fit-for-purpose technology solutions enhances access, accelerates enrollment, improves representation, and increases compliance and retention, Strategies for successfully hiring and growing a ClinOps team in this day and age, Discussing how training improvements can increase retention, WFH vs in office: Pros and cons of managing a more remote ClinOps team in the US. Can you share some of your workflow procedures? 2022 edition of Outsourcing in Clinical Trials & Clinical Trial Supply East Asia Conference will be held at InterContinental Seoul Coex, Seoul starting on 29th November. 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. She is a Nurse Practitioner by training and spent over 10 years caring for patients before coming to industry. Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. 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. Joined industry with a goal of developing digital and devices to improve patient care. To learn more , please visit our website - TICKETED. Our Provider Edition offers a CRO costing module and bid benchmarking. Our Ergomed team is looking forward to exhibiting at Outsourcing Clinical Trials - Texas 2022, December 7th & 8th . We offer Bioanalysis for small molecules and biologics for PK, immunogenicity and biomarkers utilising the platforms of LC-MS/MS (7) and Immunoassay (MesoScale, Gyrolab). To learn more , please visit our website - Altasciences helping sponsors get better drugs to the people who need them, faster. Scalable, Reliable. 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. ARENSIAs outstanding recruitment performance across numerous disease areas substantially reduces the overall number of sites and countries for any early-phase patient trial. She has actively participated in departmental preparation for the EU CTR implementation and is one of ICONs SMEs on this topic. 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. What are global biotech executives asking/concerned about when evaluating Phase I study plans? Improving the patient experience through user-focused design. Amsterdam RAI. Date: January 18 - February 17, 2023. To learn more , please visit our website - I am the CEO at OrPro Therapeutics, a biotechnology company in San Diego, CA developing biologic drug solutions to unmet needs in serious epithelial diseases including cystic fibrosis. To learn more , please visit our website - About Mobile Technologies in Clinical Trials. Aug 05 International Conference on Clinical Trials in Endocrinology (ICCTE) - Montreal, Canada. 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