https://www.advancedclinical.com/. 11 th International Conference on Clinical Trials is scheduled to be held during November 09-10, 2023 at London, UK. 3 rd Clinical Pharmacy Conference. 4240 La Jolla Village Drive. www.frontagelab.com. This conference intends to focus on the global health and clinical trials around the world. Arena International are delighted to announceOutsourcing in Clinical Trials West Coastwill be returning to Burlingame for the annual event onMarch 1st& 2nd2023! She has an extensive background including several years of experience in field medical as well as over 6 years in medical affairs. An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps. vial.com. Debashish has previously managed successful eTMF products at Veeva and Medidata, as well as clinical trial imaging tools at Synarc (now part of Clario). Rave RTSM streamlines your operations and provides real-time visibility for your study teams. Strategy/Planning: How do you make the decision to run a DCT; what are the considerations? Amy has been a drug discovery and development professional for 25+ years, including progressive roles in clinical operations and clinical strategy. Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders. Mr. Larwood co-invented his first two commercial molecules before age 30. www.greenlightclinical.com, To learn more , please visit our website - Finding patients is a challenge. Additionally, Funwie collaborates with colleagues to co-create educational resources as a part of the core team of the Advancing Inclusive Research Site Alliance, which focuses on addressing disparities in clinical research. 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. Recognising how Social Determinants of Health contribute to outcomes in disease, Assessing which communities you arent successfully recruiting from and exploring data to understand why, Focussing on education in this space and what we can all do moving forward. Lead on the diversity and inclusion team, and member of DTRA, CISCRP and other industry consortiums aimed at improving access to clinical research and providing clinical research as a care option. All three clinics are strategically co-located within leading medical, research and biotech precincts offering unique access to ancillary services including bioanalytical laboratories, MRI, lumbar punctures, chest X-rays, ophthalmology assessments and others. 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. 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. 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. 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). 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. She has over 22 years of experience overseeing GxP quality and compliance for all phases of drug development for biologics and small molecules. To learn more , please visit our website - To learn more , please visit our website - The DPO Centre isEuropes leading life science experts, providing Data Protection Officer (DPO) and Data Protection Representative (DPR) services. Philips BioTel Research is an industry leader in medical imaging and cardiovascular safety testing for clinical trials. 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 . Review market analysis on location of Phase I studies and discuss why these choices are made. With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/WRS) expertise at our core, our services are scalable via our strategic partnerships to provide full-service clinical trial solutions that are The Right Fit For You. www.maxisit.com/ctos/. Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. Add the event to your calendar. Chief Executive Officer, Agility Pharmaceuticals, Dr Mishra (Ex Genentech, Ex NCI, Ex NIH) is the founding president and CEO of the American Association for Precision Medicine ( and chair of ACT AAPMs Coronavirus Taskforce He is leading research efforts focused on preventing curing chronic diseases not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives He is also the founder and CEO of Agility Pharmaceuticals, a pharmaceutical company committed to revolutionizing drug discovery development through technology, big data, robotics, and artificial intelligence He is a serial entrepreneur who founded his first company after graduating high school, and his second company during his Ph D Since then, he has accumulated a wealth of experience by building, investing, and advising numerous other companies He is an investor, co founder/ board member of a few corporations, focused on accelerating drug discovery/ development, data analytics, robotics, mental health, and digital health He is also the founder of AAPM Angels and Investors AAi an investment group focused on investing in drug discovery, diagnostics, precision medicine, technology healthcare companies He is also the founding investor and advisor to Barcelona Ventures and serves as an advisor to a 100 M private equity fund Widely recognized as a thought leader in the field of technology and healthcare, Dr Mishra has keynoted, chaired, curated, and organized numerous successful international conferences He served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche Where he participated in several drug discovery project teams Moreover, his passion for drug development and precision medicine has led to the identification of new drug targets, biomarkers, companion diagnostics, and several drugs/ combinations in the clinic His research work has been recognized globally by over 40 prestigious awards and honors Due to his unique perspective selfless service, he is a highly respected sought after mentor to many The companies that he has advised have raised multimillion dollars Notably, he serves as a mentor and advisor to several VC funds and startup accelerators, including IndieBio HIMSS/Health 2 0 s Project Zygote, MedLabs ZGC Capital, J&J JLabs UCSF Innovation Venture, UCSF Invent Fund, and California Life Sciencess FAST program, to help grow Californias life sciences innovation ecosystem, Chief Executive Officer, Strategikon Pharma. www.saama.com. Promedica International is a privately held, full-service CRO providing clinical trial services for the medical device, biotechnology and pharmaceutical industries. www.prevailinfoworks.com. This session examines how scientific rigor can be applied to clinical outcome assessments (COAs) even though they are subjective. Visit our website to learn more about how we deliver a Better Clinical Experience. Dr. Cunningham came from academic background. Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. For more than 40 years, Emmes has been dedicated to research for a healthier world. Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. To learn more , please visit our website - 6 th Clinical & Forensic Pathology Conference. 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. Flex Databases platform is a secure, unified and compliant system for clinical trials. To learn more , please visit our website - To learn more , please visit our website - How do you arrange with and clean the large amounts of data generated? Our biotech recruiters, pharmaceutical recruiters and scientific recruiters provide multiple solutions spanning temporary and permanent placement to clients ranging from venture-backed start-ups to Fortune 500 firms. She is also a Certified Clinical Research Professional, and a trained journalist. Novotech is an Australia based clinical CRO operating across Asia and South Africa. From 2 to 4 November 2020. Dr. Cunningham has over 15 years experience in clinical leadership position in medical device industry, overseeing a full spectrum of clinical development programs ranging from FIM to pivotal to post-market phases. 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. ), both from Duke University where I was also an undergraduate. Myonexis a global complete clinical trial solutions provider. Bruce started his career on the faculty in the Chemistry Department at Purdue University where his independent research focused on neuronal signal transduction. To learn more , please visit our website - A healthy discussion on different disciplines in pre . To learn more , please visit our website - To learn more , please visit our website - She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. To learn more , please visit our website - http://www.yprime.com/, Curebase leads decentralized clinical research using a sophisticated eClinical software platform that manages all site/patient data capture, along with a fully virtual site that acts much like a traditional site, but with greater flexibility and reach. She is mastering the logistics of dosing and testing clinical trial participants where they live, work, and study. Learn more about and Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp. Tactical clinical operations in digital health studies, First-hand learnings, breakthrough device system, a case study. Genentech Chief Diversity Office, Patient Inclusion And Health Equity. Agilex Biolabs is the leading Australian Bioanalytical CRO providing regulated Bioanalysis to support clinical trials. . CROMSOURCE operates offices across Europe and North America. To learn more , please visit our website - Europe's leading clinical trials conference focusing on partnerships, outsourcing, operations and technology is now In-person event. 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. eCOA is our core focus but not our only service. Medocitys platform captures valuable real-time clinical insights & real-world data, while engaging patients, sites, and sponsors. 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. Theyll ensure your translations will be of the highest quality, on time, and within budget. Our Precision Matching software mines millions of patient records, including unstructured physician notes, to pin-point eligible study patients in real-time. www.td2inc.com. Data-driven operations and oversight with elluminate. KPS is a global, innovative, Clinical Outsourcing Provider delivering clinical trial monitoring, management and quality oversight services to pharmaceutical, biotechnology, medical device, and related industries. To collaborate with CISCRP for your upcoming event, please contact Joan Chambers at jchambers@ciscrp.org or Lindsey Elliott at lelliott . IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. His goal is to help you accelerate your clinical research career and be a more effective leader. www.eclinicalsol.com. 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. We help teams bring order, trust, and predictability to protocol execution and automation. Slope makes clinical trials boring by using real-time data to orchestrate operational complexity. AliveCor, Inc. is transforming cardiological care using deep learning. 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. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. Exploring incentives for the community if not financial what else can you offer? www.iqvia.com. Includes management of the RFP process for outsourced services as well as contract/proposal and budget negotiations, vendor selection, and vendor oversight/relationship management. Precision medicine is in our blood, our cells, our genes, and our name. 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. This presentation will discuss: With increasing site staff/physician burnout and sites taking on less projects, we are still feeling the ripple effect of this on trials. Signant unites eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industrys most comprehensive patient-centric suite an evolution built on more than 20 years of proven clinical research technology. Signant Health provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. Henry earned his B.S. Clinical Outcome Assessments (COAs): Applying scientific rigor and good instrument design. For the past 10 years, Estela has co-facilitated support groups, led, and participated in educational symposiums, advocated locally and nationally. We are a certified Minority Business and always do the right thing. http://strategikonpharma.com, To learn more , please visit our website - www.agilexbiolabs.com. http://www.cluepoints.com. AWT Healthcare is solely focused on providing the clinical pharmaceutical and custom labels & packaging industry with state-of-the-art solutions at a fair price and competitive timing. Join thought leaders from regulatory agencies, biotech, pharma, patients, and academia to discuss the latest advances, challenges, and forward-thinking . To learn more , please visit our website - Date: January 18 - February 17, 2023. Pharmapack is the European event focal point for the pharma packaging and drug delivery device industry. Proven ability to organize and manage late-stage development cross-functional teams completing projects on time with meticulous attention to detail. To learn more , please visit our website - http://www.celerion.com. Home / Events /. Our Sponsor Edition includes dedicated applications for clinical study planning and budgeting, outsourcing and forecasting. 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 . Aug 05 International Conference on Clinical Trials in Endocrinology (ICCTE) - Montreal, Canada. FIRESIDE CHAT: Addressing the growing challenge of staff shortages and site delays to develop a seamless contracting and start-up phase. 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. Clinical Trial Supply New England . We offer both single modules and a unified solution to maintain all processes you can cover all existing software needs with only one vendor. Partnerships in Clinical Trials Europe 2020. Our Leukopaks are available for Research Use Only and Clinical Grade (FDA 21 CFR 1271-compliant) applications. To learn more , please visit our website - Enhance site negotiations and pay with ease, with the industrys first Procure-to-Pay solution designed specifically for clinical trials. Reem holds a PhD in genetics from the Hebrew University of Jerusalem. Optimizing cell-based Gene Therapy Programs through the continued evolution. We work With HeartTMevery day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. Explore Modern RTSM Solutions. Explore online site training as a less time/labour intensive way to educate site. Wed, 25 May 2022, 18:00 WebSite. This enables earlier submissions with the potential of coming to market sooner and recovering R&D investments ahead of projections. 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. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact by driving quality, mitigating compliance risk, and enhancing patient engagement. 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. Meghan received her Masters Degree in Human Biology at San Francisco State University and her Bachelors Degree in Economics at University of North Carolina, Chapel Hill. The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. . An opportunity at Gilead Sciences sparked her move to the West Coast, and she is now settled in the San Francisco Bay Area. To learn more , please visit our website - Emmes acquired Casimir in March 2022, and the . Our platform consists of 13 modules that cover every aspect of clinical trials, from project startup to pharmacovigilance. September 28-29, 2022. It was through this privileged relationship with patients facing devastating diagnoses that Meghan witnessed first hand the life-saving and life-enhancing effects of medical and therapeutic intervention thus piquing her interest in the drug development process. http://greenphire.com/. 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. Despite the ongoing disruptions from COVID-19, 2021 saw some major results from clinical trials. In his role as BD lead, he is responsible for many aspects of the companys planning and operations. Chemistry degree from Punjab University, Institute of Chemistry, Executive Director, Global Digital Quality Management Systems and Business Intelligence BeiGene, Executive Director, Global Medical Affairs Study Management, BioMarin Pharmaceuticals, Inc. Wendi Carroll received her Pharm D from the University of the Pacific. She is currently managing a Ph3 program in rare liver disease. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. Alton Sartor completed a combined MD/MBA from Tulane University. 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. To learn more , please visit our website - https://www.calyx.ai. 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. ClinDatrix, Inc., a CRO, helps pharmaceutical, biotechnology and medical device innovators with clinical projects ranging from Phase I studies to multinational pivotal Phase III trials and post-marketing studies. From 2 to 4 November 2021. 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. Were streamlining your research, helping you get to your next milestone faster. We have expanded our product line to include Medical Device Labeling through AWT Labels & Packaging. 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. More recently, Arun headed to Santen, with a focus on driving operational excellence in Ophthalmology clinical research as Associate Director Global Clinical Development and Operations, where he oversees Phase 1 4 clinical trial conduct. 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. Does it offer a solution? Why expert partners and staff matter; what metrics dont tell. Esther Marfo, is a Project Leader within the Health Equity and Population Sciences department at Genentech. He held senior level positions with Relypsa (acquired by Galenica for 1.52B US$), Anacor (acquired by Pfizer for 5.2B US$) and Transcept Pharmaceuticals (revers merger with Paratek). Overview. 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. 2022 looks to be a bumper year too, so Nature Medicine asks leaders in their field what they think . Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. Digital health technologies and biomarkers in clinical trials requires the highest standards of data collection, transmission, security, quality, and analysis. 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. Joined industry with a goal of developing digital and devices to improve patient care. 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. Datacubed applies innovative solutions for the capture of active and passive data for engagement with patients in in-person, hybrid, or fully virtual clinical studies. Keeping them can be an even bigger challenge. At Medable, she works cross-functionally with engineering, product development, regulatory, AI/ML, and data science to develop first-in-class DCT solutions. 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. With presentations and panel discussions on the top industry trends and outsourcing challenges, and . RT1 Conducting a study when there is minimal education, Hang Nguyen, Sr. Director, Clinical Affairs, Materna Medical, RT2 Navigating the complex spiderweb of multiple vendor relationships, Sarah Mullen, Vice President of Clinical, HeartFlow, RT3 Training Strategies for a Novel Therapeutic Medical Device, Ann Louise Armstrong, Senior Manager of Clinical Affairs and Field Operations, Ancora Heart, - How the process started and steps taken, - Assessment of eligibility and submission, - Lessons learnt - how it helped and what we did, what we companies can learn and do better, Discussion focusing on Real World Data; an overview of opportunities and challenges in working with RWD/RWE, Ted Chun, Director, Global Clinical Shared Services, Stryker Neurovascular, RT2- Navigating the complex spiderweb of multiple vendor relationships, RT3- Training Strategies for a Novel Therapeutic Medical Device, Ann Louise Armstrong, RN, MSN, CCRC, CCRA, Senior Manager of Clinical Affairs and Field Operations, Ancora Heart. Contact us for more information and for a live demo tailored to your use case and needs. We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date. Actalent is a leading provider of Clinical and Laboratory services. 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. For over 25 years, Altasciences has been integrating into clients projects to help support educated, faster, and more complete early drug development decisions. www.viedoc.com. During her career she has supported Class 1-3 devices through the entire product lifecycle. https://www.parexel.com/, To learn more , please visit our website - Prior to joining Iovance she served as the VP of Quality at Immune Design which was acquired by Merck. We develop new innovations, drive emerging therapies forward and improve patient lives. . 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. As a CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. Flexible. Why having IRT experts involved in your study is important. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. 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. 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.

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