Hang Nguyen brings over 20 years of medical device clinical research and is currently the Sr. Director of Clinical Affairs at Materna Medical, a novel OBGYN platform company defining a $6B market in the most common pelvic conditions women face. Her experiences in academia, biotech, and CROs confirm that meeting the needs of all stakeholders payers, regulators, patients, families, and sites is a critical success factor for efficient development programs. ARENSIAs speed and data quality provide our Partners/Sponsors with a strategic advantage across the entire lifecycle of a project, as they can progress their novel compounds much faster to later phases of research. OMDRHO is one of five programs in the Office of Medical Products Operations within FDAs Office of Regulatory Affairs. 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. February 28, 2023. . 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. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. Rho, a contract research organization (CRO) located in Chapel Hill, NC, provides a full range of services across the entire drug development process. 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. 25 people interested. For the 13 th Annual event, our flagship European clinical show will provide delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials . Partnerships in Clinical Trials Europe 2020. https://www.anjusoftware.com/, To learn more , please visit our website - Going the last millimeter: What you may not know about home visits. The Technology track will seeKimberley Ferguson(Commercial Head of Personalized Healthcare Partnerships, Genentech) discussing all thingsWearables. Medrio is the leading provider of eClinical technology for pharma, biotech, device, diagnostics, and animal health clinical trials. To learn more , please visit our website - https://www.calyx.ai. How applying behavioral science insights can better inform the way we do patient engagement. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022. It offers its clients a global reach through a network of 38 processing laboratories. Karl has collaborated with the world's top 20 pharmaceutical companies and has extensive experience in patient-centered outcomes research, eCOA strategy, and drug development. Debashish has over 18 years of experience in the life sciences / clinical trials industry, including several leadership roles in Product Management. Weve all had to sit through several pitches from vendor companies telling us what they can do for us, but now its time to reverse the conversation! To learn more , please visit our website - Joined industry with a goal of developing digital and devices to improve patient care. AWT Healthcare manufacturers clinical trial labels. LabConnect provides global central laboratory services including routine and esoteric lab testing, kit building, sample management, biostorage and scientific support services for our biopharmaceutical clients. For over 25 years, Altasciences has been integrating into clients projects to help support educated, faster, and more complete early drug development decisions. TORONTO, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions and services focused on small-to-medium life science organizations, will be exhibiting at Outsourcing in Clinical Trials New England 2022, October 12-13 in Boston, MA. 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. Frances has an undergraduate degree in Physiology and a PhD in medical science from the University of Sydney. We work With HeartTMevery day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. Imaging endpoints are often used to support go/no-go decision-making in early phase trials. Based outside Philadelphia, Pennsylvania, we pride ourselves on being boutique by design and always customer focused. actalentservices.com, To learn more , please visit our website - 5 th Global Pharmacovigilance Summit. Alexis Garelli has over 15 years of diverse healthcare information and pharmaceutical software technology experience. Bioethics, regulations, patient recruitment, site selection, real-world data, data integration & Strategy, outsourcing, vendor management, quality (QbD) in Trial Conduct, risk-based . Cultural consideration - translations, typical distance from site, etc. 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. 30+. THREAD is a leading provider of a proprietary, decentralized research platform and suite of supporting services used by biopharma, CROs and life science organizations to remotely capture data from participants and sites during, in-between and in lieu of in-clinic visits. Agilex Biolabs operate a fully quality-assured, FDA-inspected laboratory (ISO/IEC17025 and OECD GLP). Medocitys platform captures valuable real-time clinical insights & real-world data, while engaging patients, sites, and sponsors. Our latest enhancements include patient genetic and biomarker matching to promote swift site identification and patient enrollment. He brings over 25 years of product management, consulting, and engineering experience across verticals such as life sciences, enterprise software, healthcare, government, entertainment and manufacturing. http://www.clinicalink.com/, To learn more , please visit our website - 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 Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget Join us for a two day event filled with case studies, panel discussion and face to face networking opportunities around clinical operations, technology and innovation, and data management. 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. Practiced Neuro-Oncology and General Neurology at the VA and Boston Medical Center. His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever. In 2010 she became the Deputy Director of ORAs Southeast Region, and in 2012 she assumed the responsibilities of Acting Director for the Southeast Region. BS in Human and Organizational Behavior, and Communication Studies and authored numerous trade articles and frequently present on behalf of Parexel at trade conferences. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. 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. Since 2000, Anne has held supervisory and branch director positions. Prioritizing patient diversity. Stream B: Clinical Innovation & Technology, A Fireside Chat on. We are focused on helping our clients to address their most significant and complex drug discovery and development challenges. vial.com. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. Exploring new science and a futuristic perspective on AB/AM drug development, Exciting growth of artificial intelligence in medicine, A framework on development of artificial intelligence in medicine, The power of public attention and funding, Business opportunity of artificial intelligence in medicine, What they like to see in an outsourced partner organization, What they would like a partner to know about them / how they work. Making progress of a complex Interventional device study during covid. To learn more , please visit our website - To learn more , please visit our website - I look forward to being in the Bay Area in early Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences #outsourcing 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. Were a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. How data mining clinical trial costs and benchmarks can lead to operational efficiencies, The impact of macroeconomic factors on clinical trials and how to best combat changes, How to reimagine financial stability and planning for clinical trials, Clinical Trials: Success & attritions. 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. Additionally, our tech-enabled trial management system, streamlined study startup processes, centralized pre-screening call center, and unparalleled approach to patient recruitment will successfully deliver a superior CRO experience. The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. Understanding Social Determinants of Health: Identifying the variables that burden trial participants how can we collect this data? March 1 - March 2,2023 Outsourcing in Clinical Trials West Coast. www.curebase.com, To learn more , please visit our website - Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. https://www.medidata.com/, To learn more , please visit our website - Genentech Chief Diversity Office, Patient Inclusion And Health Equity. Supported by top pharmaceutical and biotech partners across 20 different therapeutic areas, Care Access is scaling and globalizing its new model for clinical trial delivery, where more physicians and patients can engage in life-saving research to develop new therapies faster. 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. Meghan serves as the VP, Clinical Trial Financial Management at Medidata driving roadmap and strategy across our Grants Manager and Site Payments products. KardiaMobile 6L provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Supraventricular Ectopy, Sinus Rhythm with Premature Ventricular Contractions, Sinus Rhythm with Wide QRS, and Normal Sinus Rhythm in an ECG. To learn more , please visit our website - I am very excited to be attending Clinical Outsourcing Group UK this year in London! Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables. To learn more , please visit our website - Dr. Hayat is managing partner of Revive Pharm USA. 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. RxE2 Releases . To learn more , please visit our website - http://www.premier-research.com/. Agilex Biolabs is the leading Australian Bioanalytical CRO providing regulated Bioanalysis to support clinical trials. 21 - 22. Why having IRT experts involved in your study is important. 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. www.agilexbiolabs.com.
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