A significant portion of the cost in a clinical trial can be attributed to operational conduct of the trial such as site monitoring related activities, data management and site oversight. Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Zigzag aims to provide straightforward, reliable and flexible Quality Assurance and auditing services on a local or global basis. He worked as a Research Associate to improve recruitment metrics in the Million Veterans Program genomic biobanking initiative for Loma Linda VA Medical Center where he developed a novel Point of Care recruitment solution in outpatient clinics. As a service company, our mission is the pursuit of health equity, a focus on diversity and excellence in clinical trial conduct. Are Hybrid trials the more realistic and practical approach compared to full DCT agree or disagree? She is driven by listening and incorporating the patient voice and by finding innovative ways to improve the patient experience. 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. http://www.kpslife.com. 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. Prior to SDCs inception, Richard served on the Board of Directors of Ora, Inc. (www.oraclinical.com) for over 10 years. Tickets. Pro-ficiency ensures that everyone in your study is compliant with all training requirements. Parexel Recognized by Frost & Sullivan with 2022 Global Customer Value Leadership Award . The 15th Annual Outsourcing in Clinical Trials New England event will bring together clinical trial professionals from big and small biopharma to uncover new technologies and processes, to optimize their clinical and outsourcing operations. 2 nd Clinical Case Reports Conference. The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia. 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. Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem. She serves as an advisor for early phase study teams in developing inclusive clinical trials. Our platform allows site staff to pull data from various sources such as EHR and legacy systems automatically into their eCRFs (Fully agnostic) hence helping significantly reduce the double-data entry efforts (demographics, labs, vitals, adverse events, allergies, medications) and time spent with CRAs during monitoring visits. The 2014 event will focus on how companies from the region can implement effective clinical outsourcing strategies. Each year, we bring forward the latest experience . Wednesday, 28th Sep 2022 - Thursday, 29th Sep 2022 . www.rad-md.net. Our intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable hundreds of sponsors and CROs (including all Top 20 pharma) to extend the reach of drug development, expand patient opportunities and improve data quality helping them bring life-changing therapies to our families and communities around the world. By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Exploring the need for a dedicated regulatory pathway for antibacterial/antimicrobial drugs. www.zigzagassociates.com. ClinChoice is a leading full-service clinical CRO offering high-quality solutions to pharmaceutical, biotechnology, medical device and consumer products clients. 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. Phase 1 Trials: How to globalize to accelerate value inflection. www.myonex.com. Clinical ink is the global life science company that brings data, technology, and patient science together. 28 - 29. We work With HeartTMevery day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. Esther Marfo, is a Project Leader within the Health Equity and Population Sciences department at Genentech. https://www.nucleusnetwork.com/au/, To learn more , please visit our website - You might have known us as Myoderm as we have recently changed our name but not our high-quality services as the complete clinical trial supply partner. This conference will explore the latest regulatory updates, global clinical trials, advanced technologies and more. September 28-29, 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. Examining the behaviors of clinical trial stakeholders to better understand challenges in patient participation. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. TORONTO, March 23, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions . The Budget Conundrum. To understand site-side difficulties in trial recruitment and conduct, Arun served as a Senior Clinical Research Coordinator for Cardiology Phase 4 trials at the Loma Linda VA Medical Center, and as a Lead Clinical Research Specialist for Investigator-Initiated and Phase 0 3 Gastric Neuroendocrine Rare Disease trials at Stanford Cancer Center. Isabel Brown (she/her) currently works on the Inclusive Research and Health Equity team for Genentech's Research and Early Development, Clinical Operations group. 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. Specializing in clinical development and staffing solutions, we offer a flexible approach to ensure our clients unique needs are supported. 1333 Bayshore Highway, Burlingame, Frances has an undergraduate degree in Physiology and a PhD in medical science from the University of Sydney. http://www.premier-research.com/, To learn more , please visit our website - We are committed to delivering high-quality, cost-effective services according to sponsor timelines and specifications. 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. To learn more , please visit our website - www.eclinicalsol.com. Medrio is the leading provider of eClinical technology for pharma, biotech, device, diagnostics, and animal health clinical trials. www.td2inc.com. 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. The 2022 program boasts two full streams including: www.advanceresearch.com. Practical use cases to improve clinical site efficiency with technology. From 7 to 9 November 2022. This event is a great opportunity to get to know the online casino players who will be performing at this meeting. His expertise is in regulated content management, and he is a member of the TMF Reference Model Project Team. Should our biggest concern post-covid be remote working? http://www.medpace.com/. Extensive Outsourcing and Contracts experience in the area of Clinical Development primarily at small to mid-size biotech organizations. With presentations and panel discussions on all the hottest industry trends and outsourcing challenges. Current topics in the Medical Device Regulatory Landscape, Presented by the FDA. To learn more , please visit our website - Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine. We are now in the position now to share our practical experiences with Decentralized & Hybrid Clinical Trials; The bedrock of a successful trial is a well-designed protocol with reliable measurements of biomedical and health-related outcomes to satisfy regulatory standards. Dr Morimoto has over 25 years of industry experience in leading project teams in the development of innovative medicines, providing guidance in the design and execution of preclinical, clinical and regulatory strategies with a therapeutic focus in Parkinsons, Alzheimers and frontotemporal dementias. Francis is an expert in clinical system regulatory compliance with over 20 years pharma experience spanning R&D, manufacturing and clinical research. Flexible. Liza has extensive experience in managing and overseeing phase I-IV clinical trials globally as well as building and growing clinical operations teams in oncology, cardiovascular, metabolic and liver diseases, HIV and trials in gene therapy. www.medocity.com, To learn more , please visit our website - April 28-29, 2016 Dubai, UAE. 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 collaborative approach helps maximize efficiency and agility by acting as an experienced member of your team. Meghan joined a CNS-focused start up in RTP and has spent the last 15+ years working in the life science technology industry. eurofinscentrallaboratory.com/biopharma-services. atreo.io, To learn more , please visit our website - Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence. As the Founder and Chairman, he spearheaded the ACS ProSpectives international conferences on, Process Chemistry in the Pharmaceutical Industry, and as the chair, speaker and the moderator at numerous national and international conferences on API Process Chemistry, ADCs and Drug Discovery & Development. 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. She has a unique perspective in leading clinical programs in a dynamic startup environment. As the IPM, he is the District liaison to FDA Headquarter handling import related issues and concerns. Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. I will be there with my colleague Georgi Govedarov, come visit us at booth Isidora Teodorovi on LinkedIn: I am very excited to be attending Clinical Outsourcing Group UK this year 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. To learn more , please visit our website - To learn more , please visit our website - Executive Director, Program Strategy, Rare Disease and Pediatrics, Premier Research, https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/, https://eurofinscentrallaboratory.com/biopharma-services/, eurofinscentrallaboratory.com/biopharma-services, Hyatt San Francisco Airport, Burlingame, San Francisco, Best practices for engaging the patient community and growing that relationship using real life case studies. Our Australian phase I facilities are in Melbourne and Brisbane, and our US phase I facility is located in Minneapolis. She has been with Calyx for 17 years as a key strategic leader, with a specific focus on IRT solutions. Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. Jay holds an MBA from Villanova University and a degree in Computer Science and Physics from Gettysburg College. Flex Databases platform is a secure, unified and compliant system for clinical trials. Worldwide is changing how the world experiences CROs in the best possible way. eCOA is our core focus but not our only service. Meraf Eyassu is a Executive Director of Clinical Operations at Terns Pharmaceuticals. 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). The Association of Clinical Research Professionals (ACRP) supports clinical research professionals through membership, training and development, and certification. 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 At UCSF he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. 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? Parexel Introduces Expert SeriesNew Medicines, Novel Insights. For over 30 years, we have been the leading global clinical trial supply company and we have expanded our service portfolio to offer complete solutions around clinical trials for our partners. To learn more , please visit our website - Their experienced research team comprises key opinion leaders, board-certified cardiologists and radiologists, sub-specialty scientists, and highly trained technicians who acquire, evaluate, and report high-quality data through an efficient, cloud-based infrastructure. 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. Dr Jankicevic holds Doctor of Medicine degree, Master of Medical Sciences degree, and Board-certification in Dermatology and Venereology from the University of Belgrade, Serbia. 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. Includes management of the RFP process for outsourced services as well as contract/proposal and budget negotiations, vendor selection, and vendor oversight/relationship management. Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. What should we be doing now to anticipate, prepare, prevent and respond? 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 . To learn more , please visit our website - www.pro-ficiency.com. April 18-20, 2016 Dubai, UAE. Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. This event is a great opportunity to get to know the online casino players who will be [] We leverage our proprietary payments platform and workflow automation to help clients improve operational efficiency, reduce costs, mitigate regulatory risks, improve the patient and site experience and produce quantifiable results that improve clinical operations and strategic planning. To learn more , please visit our website - 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. His goal is to help you accelerate your clinical research career and be a more effective leader. 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. Pharmaceutical Development. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. 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. 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. www.advarra.com. She is a career FDA federal service veteran with vast experience in technical and managerial positions across multiple commodities. We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date. https://www.propharmagroup.com/. Diagnostic Services. 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. His thesis was on the role of the Androgen Receptor in Hormone Refractory Prostate Cancer. To learn more , please visit our website - For over 25 years, Altasciences has been integrating into clients projects to help support educated, faster, and more complete early drug development decisions. Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. 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. To learn more , please visit our website - Currently he is the CEO of Certum Bio in San Francisco Bay area and honors the co-appointment as the Member of the Board of Advisors, UC Berkeley Postdoc Entrepreneurs Program (BPEP). AliveCors enterprise platform allows third-party providers to manage their patients and customers heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies. As a CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. Brandi Coffin has been in the medical device industry for over 15 years with various roles in post market surveillance, quality, compliance and patient safety. 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. 4240 La Jolla Village Drive. With presentations and panel discussions on the top industry trends and outsourcing challenges, and . Her passion for ensuring that clinical trials are reflective of our society drove her to her most recent work in Health Equity, where she works with a group of committed and passionate individuals to successfully develop and implement scalable and sustainable strategic interventions for the recruitment of underrepresented patient populations. To learn more , please visit our website - 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. For more than 20 years, Axiom has delivered data-driven, powerful and cost-effective eClinical Solutions and Services dedicated to small-to-medium life science companies. 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. Compare and contrast the FDA, MHRA and TGA regulatory requirements for Phase I clinical entry. Slope makes clinical trials boring by using real-time data to orchestrate operational complexity. His clinical trial experience spans from set-up to delivery across all phases in a wide variety of disease and therapeutic areas. Aug 09 International Conference on Drug Development, Clinical Trial Phases and Technology (ICDDCTPT) - Lagos, Nigeria. AbbVie reports rise in full-year 2022 net revenues; Teva Pharmaceutical reports 5% fall in Q4 2022 revenue; Merck reports 2% increase in worldwide sales in Q4 2022; Companies.
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