outsourcing in clinical trials conference 202210 marca 2023
TORONTO, March 23, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions . Improving communication, relationships and work-life balance with your internal team as well as partners. Vial is a next-generation CRO that leverages the nationwide Vial site network to ensure faster, higher-quality trial outcomes for sponsors. We help teams bring order, trust, and predictability to protocol execution and automation. Start. Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. 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. About Mobile Technologies in Clinical Trials. http://citlabels.com/. Dr. Karl McEvoy has over a decade of industry experience in both the vendor and sponsor sides. Frontageis a CRO providing integrated, scientifically-driven research, analytical and product development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals. We integrate clinical operations excellence, laboratory expertise, and advanced data sciences to deliver on the promise of personalized therapy; translating research into real-world results and forever reimaging how to get there. 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. Decentralized Clinical Trials 2022 was a really good opportunity to . http://www.labconnectllc.com/. Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. The Outsourcing in Clinical Trials Texas event aims to be a solution-driven conference that allows Clinical Operations professionals to network with innovative vendors, hear cutting-edge content, and participate in interactive discussions. assisTek has been paving the way for integrating technology and data collection in clinical trials for over 25 years. The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. David Hadden is the pioneer of AI-driven Virtual Patient Simulation technology. Powered by the IQVIA CORE, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. eurofinscentrallaboratory.com/biopharma-services. Pharma/Medical Device/Biotech Delegate - Complimentary Pass Register Now. From 2 to 4 November 2020. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. This session examines how scientific rigor can be applied to clinical outcome assessments (COAs) even though they are subjective. Explore online site training as a less time/labour intensive way to educate site. 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. 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. www.gobio.com/clinical-research/. With presentations and panel discussions on all the hottest industry trends and outsourcing challenges. August, 2023. Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. To learn more , please visit our website - https://www.parexel.com/. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. Our experts are ready to discuss how our solutions can best support your live studies. She intentionally injects laughter and authenticity into everything she does, and is an advocate for kindness, diversity and inclusion, as well as issues impacting women and children. 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. In 2010, he became a Supervisor Consumer Safety Officer (SCSO). To learn more , please visit our website - Medidata is leading the digital transformation of life science, with the worlds most used platform for clinical development, commercial, and real-world data. The company specializes in end-to-end services supporting drug discovery, precision medicine and clinical development for smarter clinical studies. Topics include feasibility & site selection, clinical data & technology, patient engagement & enrollment, risk-based monitoring, and budeting & clinical outsourcing. Our mission is to eliminate the barriers to clinical trials by bringing access to people where they live, work and are willing to engage. I look forward to being in the Bay Area in early Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences #outsourcing Arena International are delighted to announce the Outsourcing in Clinical Trials Southern California Event will be returning to California's La Jolla on September 26th & 27th 2023! 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. Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. ARENSIA is trusted by Leading Pharmaceutical and Biotechnology organizations worldwide. Solution-oriented professional, with strong problem solving capabilities. Sandy Mohan is the VP of Quality at Iovance Biotherapeutics. https://www.discoverinternational.com/. ProTrials works with sponsors in the pharmaceutical, biotechnology and medical device industries to deliver high-quality clinical development services in a wide range of therapeutic areas. Earlier as a bench chemist, he was the first to make Iotrolan, a CT X-ray contrast agent, generic for decades, replaced in about 2005 by newer agents. Theyre more likely to finish on time and on budget. To learn more , please visit our website - https://www.anjusoftware.com/. He received a Certificate for Graduate Biostatistics at Harvard University Extension. 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. Emmes acquired Casimir in March 2022, and the . We offer customizable specimen collection kits, specialty testing capabilities, dedicated project management and trial site support, biostorage, and real-time data management and reporting. Ms. OBrien has been conducting clinical research for more than 35 years and has covered multiple functions during that time. Current topics in the Medical Device Regulatory Landscape, Presented by the FDA. Clinical Trials 2023. Actalent is a leading provider of Clinical and Laboratory services. To learn more , please visit our website - EVENT - DIA Global Pharmacovigilance and Risk Management Strategies Conference. She is driven by listening and incorporating the patient voice and by finding innovative ways to improve the patient experience. Booth #4. As a supervisor, he had the opportunity to manage an Import Field Operation Team, an FDA team in the Centralized Examination Stations (CES), and the Los Angeles International Mail Facility. 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. Amsterdam RAI. For the past 10 years, Estela has co-facilitated support groups, led, and participated in educational symposiums, advocated locally and nationally. Alexis Garelli has over 15 years of diverse healthcare information and pharmaceutical software technology experience. Genentechwill give a case study session onpiloting health inequities and gender identity data why collecting this data now will aide you with your clinical trial. Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget . To learn more , please visit our website - Medrio has extensive experience in all study phases and leads the market in early-phase trials. Register. www.ACMGlobalLab.com. For over 25 years, Altasciences has been integrating into clients projects to help support educated, faster, and more complete early drug development decisions. 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. She has been with Calyx for 17 years as a key strategic leader, with a specific focus on IRT solutions. 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. We offer customized solutions to fit the needs of each study, patient and site, making it easier for your patients to stick with it. Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORAs Office of Import Operations. dpocentre.com. 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. The award-winning platform gives unprecedented real-time visibility into clinical data, enabling sponsors to file New Drug Applications (NDAs) more efficiently to bring drugs to market faster and at lower costs. TD2 offers fully integrated precision oncology clinical development solutions that combine the highest standards in clinical trials management, disruptive imaging, biomarker strategies, and unparalleled access to real-time patient data. 28 - 29. Join us in Philadelphia, May 10th-11th, to shape best practice on: Refining patient recruitment strategy. Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. 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. 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. Combining patient-reported health data, personal medical records, and conversations in the Inspire community uncovers critical insights unattainable with traditional research methodologies. Commercial Services. www.emvenio.com, To learn more , please visit our website - To learn more , please visit our website - https://www.calyx.ai. Over 20 years in clinical research, including patient innovation, feasibility, strategy, patient recruitment, retention, site engagement. 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. He has worked for CROs as well as small and large biotechnology companies. 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 www.versiticlinicaltrials.org, Viedoc designs engaging software for the life science industry. https://www.trilogywriting.com/. For more than 40 years, Emmes has been dedicated to research for a healthier world. To learn more , please visit our website - He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. We are a patient-centric tool utilized to decrease the burden of clinical trial participation. Prior to SDCs inception, Richard served on the Board of Directors of Ora, Inc. (www.oraclinical.com) for over 10 years. Compare and contrast the FDA, MHRA and TGA regulatory requirements for Phase I clinical entry. 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 . Dr. Cunningham came from academic background. Advance Research Associates is a premier provider of biostatistical and data management services to the pharmaceutical, biotech, and medical device industries. She also had several leadership positions with PharmaNet Development Group (now Syneos Health), ICON Clinical Research and eMetagen Corporation. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve live. Eurofins BioPharma Services, Laboratory Testing is a group of Eurofins companies with dedicated testing facilities for global Central Laboratory Services, Bioanalytical Services, and Specialty Virology and Oncology Services. She has held key national leadership roles including advisor within the Obama/Biden administrations global HIV response team, advisor to United Nations leadership and instructor at the CDC and USAID. http://www.augustresearch.com/. https://www.chillipharm.com/. During her career she has advocated for critical partnerships with vendors supporting integration with internal stakeholders. Any Disease. http://www.axiommetrics.com/. 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. GxPs in Cell Therapy and key considerations for Quality and Project Management. Making progress of a complex Interventional device study during covid. eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date. The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. ICON plc is a world-leading healthcare intelligence and clinical research organisation. Medocitys platform captures valuable real-time clinical insights & real-world data, while engaging patients, sites, and sponsors. 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. Conference series LLC Ltd Organizes 3000+ Global Events Every Year across . We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals. To learn more , please visit our website - www.saama.com. Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. 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. Arun Sivanandam has more than 12 years of experience in clinical research at site and sponsor side. Local vendor oversight vs global provider oversight how would you manage this differently? Panellists will address the advantages of DCT; from taking the trial to the patient to boosting recruitment. In her spare time, Ndidi enjoys creative writing and interior decorating. Rhonda has more than 30 years of experience in FDA, starting as an ORA Investigator in Portland, OR before becoming a manager located in FDA's Minneapolis office. 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. We provide one of the broadest testing portfolios in the industry and this includes Safety & Efficacy testing, Biomarkers & Flow Cytometry, Cell based assays, Oncology/Pathology, Genomics, Virology, Immunology, Microbiology, Bioanalytical Services, early clinical development service and clinical trials supply. http://www.medpace.com/. 11 th International Conference on Clinical Trials is scheduled to be held during November 09-10, 2023 at London, UK. Mr. Larwood co-invented his first two commercial molecules before age 30. PANEL DISCUSSION: The concept of DCT, is it the future? How best to go about educating the patient community? Are you attending Outsourcing in Clinical Trials West 2023 conference? Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible. How do you arrange with and clean the large amounts of data generated? Our specialized experts drive scale, innovation, and speed to market for visionary clients around the world. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. Her background in Biotechnology and proficiency in Data Management solidified her proven ability to identify data integrity risks, and problem solve the most complaint path to drug submissions and approvals. Why having IRT experts involved in your study is important. Understanding Social Determinants of Health: Identifying the variables that burden trial participants how can we collect this data? www.frontagelab.com. https://www.almacgroup.com. To learn more , please visit our website - Are you choosing best in class or a bundle? His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever. 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. She facilitates policy and procedure development within OMDRHO and collaborates with medical product partners in the Office of Medical Product and Tobacco Operations, and with peers throughout CDRH during daily operations and on special projects. We are known for our superior statistical leadership and data management expertise and proud to have supported thousands of studies across a diverse range of diseases. We have five years of clinical trial experience and capabilities around the globe in over 90 countries and across any therapeutic area whether for decentralized, hybrid or fully virtual studies. Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. Liza Melchor-Khan is a Senior Director of Clinical Operations at NGM Biopharmaceuticals, Inc. with over 25 years of experience in the biotech and pharmaceutical industry. Optimizing cell-based Gene Therapy Programs through the continued evolution. 1333 Bayshore Highway, Burlingame, She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. Debashish has previously managed successful eTMF products at Veeva and Medidata, as well as clinical trial imaging tools at Synarc (now part of Clario). Kardia is the first AI-enabled platform to aid patients and clinicians in the efficient detection of atrial fibrillation, the most common arrhythmia and one associated with a highly-elevated risk of stroke. Before joining Clinical Ink in 2021, he was an Assistant Professor in the Department of Ophthalmology & Visual Sciences at the University of Nebraska Medical Center. Medable offers the most flexible decentralized clinical trial platform streamlining trials for patients, sites, and clinicians whether in-clinic or at home. 4240 La Jolla Village Drive. medtech.labcorp.com. Parexel Introduces Expert SeriesNew Medicines, Novel Insights. An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps. Subsequently, Arun lead the Gastric-Immuno-Oncology Rare Disease Bispecific-T cell-Engager portfolio at Amgen on various aspects of clinical research operations. To learn more , please visit our website - This event is a great opportunity to get to know the online casino players who will be performing at this meeting. 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. She has a unique perspective in leading clinical programs in a dynamic startup environment. actalentservices.com, To learn more , please visit our website - To learn more , please visit our website - 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. 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 currently serves as Vice President of Clinical Affairs at Endogenex, a medical device company developing innovative solutions for the treatment of Type 2 diabetes. Our commitment to excellence, innovative technologies, and therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. March 1 - March 2,2023 Outsourcing in Clinical Trials West Coast. She has worked with Calyx for over 7 years as a key strategic leader and director in IRT solutions and services. Valley Fever Solutions is a small startup working first on a new and improved treatment for Valley Fever (coccidioidomycosis), for which NikZ will transform the standard of care. www.td2inc.com. Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem. From 7 to 9 November 2022. She has authored or co-authored 10 publications and has been an advocate for STEM education throughout her career. Parexel Recognized by Frost & Sullivan with 2022 Global Customer Value Leadership Award . Advarra advances the way clinical trials is conducted to make them safer, smarter, and faster. GreenLight Clinical is a physician-led, boutique full-service clinical CRO with its own central clinical, bioanalytical, histopathology laboratories in Sydney, Australia. Kumar earned his Ph.D. from the University of Vermont and was a post-doctoral fellow at the University of Virginia. He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning. Dr. Cunningham came from academic background. CLOSING KEYNOTE: FDAs role in maintaining a secure and resilient supply chain. Phase 1 Trials: How to globalize to accelerate value inflection.