https://www.advancedclinical.com/. 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. Review market analysis on location of Phase I studies and discuss why these choices are made. To learn more , please visit our website - Date: January 18 - February 17, 2023. Precision medicine is in our blood, our cells, our genes, and our name. Sandy Mohan is the VP of Quality at Iovance Biotherapeutics. 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. Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. This conference will focus on topics such as bioethics, regulations, patient recruitment, site selection, data integration & strategy, and many more. 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. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners most high-profile drug and device programs. Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. In 2010, he became a Supervisor Consumer Safety Officer (SCSO). Saama Technologies is the advanced clinical data and analytics company, unleashing wisdom from data to deliver better actionable business outcomes for the life sciences industry. What can we do to take advantage of high prevalence of disease in populous countries but systems are either rudimentary or non-existent? 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. Of the several programs he worked at Pharma and Biotech companies, three culminated in making to the market [PaclitaxelTM Bristol-Myers Squibb; SensiparTM Amgen and DuexisTM - Horizon Therapeutics). To learn more , please visit our website - http://www.iconplc.com/. 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. 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. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture. 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. They have fewer surprises, faster outcomes, and stronger data integrity. www.harborclinical.com/. At Medable, she works cross-functionally with engineering, product development, regulatory, AI/ML, and data science to develop first-in-class DCT solutions. www.emvenio.com, To learn more , please visit our website - 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. Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence. Our customized and scalable solutions improve the quality and execution of clinical trials while mitigating costs and allowing clients to retain strategic control. www.gobio.com/clinical-research/. Rhonda Mecl recently became the Deputy Program Director after serving as the Program's Operations Staff Director for the previous five years. To learn more , please visit our website - 85356 Mnchen-Flughafen , Join NAMSA 5-6 April in Munich, Germany for Outsourcing in Clinical Trials: Medical Devices Europe. Explore and learn more about Conference Series : World's leading Event Organizer. Does it offer a solution? Are you attending Outsourcing in Clinical Trials West 2023 conference? http://greenphire.com/. Caroline Cooper is the Director of Clinical Operations at CymaBay Therapeutics, Inc. with over 10 years of experience in clinical research. 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. http://www.medpace.com/. www.kardia.com. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, To learn more , please visit our website - https://www.medidata.com/. https://www.q2labsolutions.com/, You need an Imaging Strategy thats designed and customized for your oncology clinical trial. 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. Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. Parexel Introduces Expert SeriesNew Medicines, Novel Insights. Currently a Medical Director/Patient Safety Physician Digital & Devices at Astrazeneca. What are global biotech executives asking/concerned about when evaluating Phase I study plans? Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. Explore Modern RTSM Solutions. Patient Inclusion and Health Equity, Chief Diversity Office, Genentech, Vice President, In-Home Solutions, Decentralized Clinical Trials, PCM Trials, Executive Director, Clinical Operations, Terns Pharmaceuticals. 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. Proven track record of coordinating teams in order to meet tight deadlines, set and communicate expectations, and manage deliverables. Partnerships in Clinical Trials Europe 2021. ESMO TAT, known as "The Home of Phase I in Oncology", is the leading congress focusing on promising new anticancer targets and agents, with a particular emphasis on those in early phase clinical development. Mobile in Clinical Trials is the first conference, founded in 2013 to convene R&D operations and digital leaders to get the best access, deploy and scale strategies for applying mobile/digital tools to connect and empower patients, and obtain better outcomes in drug development/clinical research. Catalyst Clinical Research is a new generation Clinical Research Organization, serving the unique needs of small-to-medium sized biopharmaceutical companies. GreenLight Clinical is a physician-led, boutique full-service clinical CRO with its own central clinical, bioanalytical, histopathology laboratories in Sydney, Australia. 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. 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. Compare and contrast the FDA, MHRA and TGA regulatory requirements for Phase I clinical entry. Electronic clinical outcome assessments (eCOA)and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. GxPs in Cell Therapy and key considerations for Quality and Project Management. With 2,000 annual trials and projects, around 200 active clients and global access to source drugs in over 60 countries,Myonex is your complete partner around clinical trials around the globe reliable, trusted and by your side. www.maxisit.com/ctos/. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence,Worldwide Clinical Trialsprovides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies. . Previous roles within both CRO and Sponsor organizations which provide valuable perspective from both sides of the industry. Flexible. Peachtree BioResearch Solutions is an Atlanta-based Clinical Research Organization that provides clinical development support services and innovative resourcing solutions to medical device, pharmaceutical, and biotech companies. 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. Strategy/Planning: How do you make the decision to run a DCT; what are the considerations? Ops components of various FIH studies and global P1-P3 drug development programs and post-marketing studies in Oncology, Hematology-Oncology, Immuno-Oncology, Infectious Diseases, Immunology, Metabolic Diseases, Ophthalmology, and Critical Care conducted in North America, Europe, Africa, Central and South Americas, Asia-Pacific regions including Japan, China, So Korea, and Australia *Lead cross-functional teams and successfully contributed to several INDs, NDAs, FDA, EMEA, TGA, and NMPA regulatory filings and approvals of marketed products within HIV/Virology Therapeutic Area *Mentor, motivate, and develop clinical operations teams and direct reports *Strong, flexible, strategic team leader with extensive change management successes *Track record to develop, problem-solve, and execute creative and innovative process improvements and quality efficiencies within development operations *Motivated and driven to continue contributing to drug development in transformative medicines with a focus on unmet medical needs, CLOSING KEYNOTE: ClinOps team focus: Managing relationships, retention and hiring in the new world. Global Player in eClinical Solutions . 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. 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. 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). Agilex Biolabs is the leading Australian Bioanalytical CRO providing regulated Bioanalysis to support clinical trials. We are committed to delivering high-quality, cost-effective services according to sponsor timelines and specifications. Dr. Cunningham came from academic background. 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. Prior to working in FDA, Mr. Solis worked in the Bioresearch field focusing on Medical Device and Drug Application Products after graduating from the University California of Irvine and the University of La Verne. Based outside Philadelphia, Pennsylvania, we pride ourselves on being boutique by design and always customer focused. He received M.Sc. Deep 6 eliminates months of manual data validation, to de-risk and accelerate clinical trials, because clinical trials should be a gatekeeper (accelerator), not a bottleneck to innovation. In another exclusive data-led investigation, Andrew and Reynald Castaeda investigate which diseases are set to have an increase in clinical trial activity this year. TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018. A healthy discussion on different disciplines in pre . With locations in the US and EU, Catalyst offers highly flexible and customized, customer-centric solutions from Global Resourcing and FSP, to Full Service Managed Solutions, with a focus on oncology product development. NikZ shows promise against other important fungal diseases. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. With the most trusted review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra optimizes research performance, empowers clinical sites, and ensures compliance. Specializing in clinical development and staffing solutions, we offer a flexible approach to ensure our clients unique needs are supported. Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables. This experience has allowed her to understand the nuances that set rare and pediatric studies apart from routine clinical studies and develop proper strategies for clients to execute their studies in real world settings. 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. He received his medical degree (MD) and his doctoral degree (PhD equivalent) from Justus-Liebig-Universitt Giessen, Germany, and his Master of Business Administration (MBA) from the Wharton School of Business, University of Pennsylvania, PA. Kunal Sampat is the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. dpocentre.com. His last company, TheraSim, trained over 1 million physicians worldwide and was sold to WebMD in 2013. Axiom Exhibiting at Outsourcing in Clinical Trials Southeast 2022. Conference series LLC Ltd Organizes 3000+ Global Events Every Year across . http://www.yprime.com/, To learn more , please visit our website - ACM Global Laboratories is one of the largest global independent central labs in the 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. What things do they need a partner to do and what they dont need! Global Clinical Trials Connect 2023 2022 London United Kingdom. 4240 La Jolla Village Drive. 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. Altasciencesis a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to preclinical and early phase clinical studies, from lead candidate selection to proof of concept. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. Gordon Chu is the Director of Investigations Branch at the Food and Drug Administration (FDA) Division of West Coast Imports (DWCI) within the Office of Enforcement and Import Operations (OEIO). ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). Henry earned his B.S. 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. 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. 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. For the past 10 years, Estela has co-facilitated support groups, led, and participated in educational symposiums, advocated locally and nationally. 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. http://catalystcr.com/. To learn more , please visit our website - Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. Pro-ficiency ensures that everyone in your study is compliant with all training requirements. Dr. Raymond completed her doctoral training in molecular biology at University of California San Diego and post-doctoral training in molecular biology at Memorial Sloan-Kettering in New York City, New York, USA. Agilex Biolabs operate a fully quality-assured, FDA-inspected laboratory (ISO/IEC17025 and OECD GLP). Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. 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. At Strategikon Pharma, we bring a high level of precision and speed to outsourced clinical trial operations through our flagship SaaS platform, Clinical Maestro. 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. To learn more , please visit our website - 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 . Why having IRT experts involved in your study is important. This is a great opportunity to network and share knowledge with regions leading pharmaceutical firms, biotechs and med device companies, discuss operationally efficient, specifically targeted clinical trials. Saamas unified, AI-driven clinical data analytics cloud platform seamlessly integrates, curates, and animates unlimited sources of structured, unstructured, and real-world data to deliver actionable insights across all therapeutic areas. To learn more , please visit our website - www.ledgerrun.com/, To learn more , please visit our website - www.versiticlinicaltrials.org, Viedoc designs engaging software for the life science industry. www.flexdatabases.com. Versiti Clinical Trials Services support biopharma and cell therapy companies through central laboratory, logistics, biomaterials provision, and IRB services. Our experienced project managers and global network of linguists are supported by proven processes and cutting-edge technology. Exploring incentives for the community if not financial what else can you offer? She has extensive experience in building quality organizations, overseeing Phase 3 global clinical trials, supporting marketing authorization applications in the US and EU, and managing pre-approval inspections leading to multiple product approvals and launches. degree in Neurobiology and is the author of several peer-reviewed papers in prostate cancer and premature ovarian failure. DCT was previously done out of necessity but are we seeing it as a new world order? To learn more , please visit our website - We are a patient-centric tool utilized to decrease the burden of clinical trial participation. Clinical Trials 2023. Dr. David Anderson is a Senior Scientist at Clinical Ink, where he focuses on the development of digital biomarkers in decentralized and remotely-monitored clinical research. We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date. PANEL DISCUSSION: The concept of DCT, is it the future? Advice for the ClinOps team to avoid unnecessary patient visits, how does your protocol affect the site? 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). Were doing more than streamlining your processes. Tactical clinical operations in digital health studies, First-hand learnings, breakthrough device system, a case study. To learn more , please visit our website - http://www.clinicalink.com/. To learn more , please visit our website - Are you choosing best in class or a bundle? Conduct of clinical trials are increasingly becoming expensive. Current topics in the Medical Device Regulatory Landscape, Presented by the FDA. UPCOMING EVENT. elluminate softwareanddata driven serviceshave been used by more than 100 life sciencescompanieson over 500 clinical trials to reduce cycle time and improve data quality. 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. Finding patients is a challenge. The conference will bring together pharmaceutical and biotech experts to connect and explore solutions to current challenges associated with clinical trials. TransPerfect Life Sciences specializes in supporting the global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Prior to starting SageMedic, he was an Associate Professor at UCSF. Network with 600+ clinical peers. TFS demonstrates scientific and medical competence across populations and therapeutics, with industry-leading capabilities in: -Dermatology, Immunology and Inflammatory Diseases, -Internal Medicine including Neurology & Respiratory, -Pediatrics, Rare Diseases and Orphan Drugs, Detailed information about TFS, and its business offerings can be obtained through.
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