Advance Research Associates is a premier provider of biostatistical and data management services to the pharmaceutical, biotech, and medical device industries. Learn how elluminate delivers: Empowering excellence in supply through digital quality management systems, In this session our guest speaker will address the challenges with these drugs in development and looking at parallels in a medical device regulatory strategy. Since 1996, ARA has supported 700+ clinical trials worldwide across all therapeutic areas. Translational Drug Development (TD2) is a world-class oncology drug development organization specializing in the development of new oncology medicines. Joined industry with a goal of developing digital and devices to improve patient care. Actalent is a leading provider of Clinical and Laboratory services. She has a unique perspective in leading clinical programs in a dynamic startup environment. Outsourcing In Clinical Trials East Coast 2022. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience. 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. 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. http://www.yprime.com/, To learn more , please visit our website - Emvenio Research is transforming how patients and care-givers engage in and experience clinical research, To learn more , please visit our website - For more information, visitwww.eclinicalsol.com, or contact us atinfo@clinicalsol.com. MaxisITs clinical data analytics platform is a purpose-fit solution developed to improve clinical trial performance, mitigate risk, and optimize clinical outcomes. To learn more , please visit our website - GxPs in Cell Therapy and key considerations for Quality and Project Management. November 28-30, 2016 San Antonio, USA. To learn more , please visit our website - Alexis Garelli has over 15 years of diverse healthcare information and pharmaceutical software technology experience. Jay has also created and managed products for eCTD submission publishing and review, enterprise quality management, document management, computer validation, as well as mobile apps for physicians, sales reps, and music and sports fans. Conference . http://www.rhoworld.com/. Currently a Medical Director/Patient Safety Physician Digital & Devices at Astrazeneca. 12 years at Parexel. Our customized and scalable solutions improve the quality and execution of clinical trials while mitigating costs and allowing clients to retain strategic control. Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. https://www.worldwide.com, To learn more , please visit our website - Bioethics, regulations, patient recruitment, site selection, real-world data, data integration & Strategy, outsourcing, vendor management, quality (QbD) in Trial Conduct, risk-based . Since our establishment in 2004, we have conducted over 700 phase I clinical trials, with 80% of our clients consisting of US based biotech and pharmaceutical companies. Jay holds an MBA from Villanova University and a degree in Computer Science and Physics from Gettysburg College. FIRESIDE CHAT: Addressing the growing challenge of staff shortages and site delays to develop a seamless contracting and start-up phase. Global Player in eClinical Solutions . Company Website:https://eurofinscentrallaboratory.com/biopharma-services/, To learn more , please visit our website - April 25-27, 2016 Dubai, UAE. 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 . www.maxisit.com/ctos/. 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. To learn more , please visit our website - Please email me if you'd like to set up a meeting to discuss your upcoming clinical trials: Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. Clinical Chemistry & Laboratory Medicine Conference. 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. Dr. Apfel is a California licensed physician with 20+ years of clinical experience in anesthesiology, critical care medicine, and emergency medicine. http://www.heartcorsolutions.com. PANEL DISCUSSION: Optimizing oversight & governance: What does oversight mean to you? She has driven program strategy and planning, including implementation of 300+ clinical study protocols in 25+ indications, by leading global cross-functional teams towards successful regulatory submissions, product launches, and innovative lifecycle management. 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. Were streamlining your research, helping you get to your next milestone faster. Vice President, CMC and Supply Chain, Union Therapeutics, Umar Hayat, Ph.D. is VP of CMC and Supply Chain at Union Therapeutics and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. Contact: Amy Apostoleris, aapostoleris@medocity.com, To learn more , please visit our website - These conferences closely focus on the advancements in clinical research and trials. To learn more , please visit our website - Long term solutions: could reducing the site certification process be a realistic solution? From 2 to 4 November 2020. 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. He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. 21 - 22. www.agilexbiolabs.com. 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. FDAs role in maintaining a secure and resilient supply chain. Henry is a Vice President of Data Sciences at Medidata. Slope makes clinical trials boring by using real-time data to orchestrate operational complexity. 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. For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. We work With HeartTMevery day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. As Vice President, Business Development at Curebase, Wayne leverages more than a decade of experience in clinical research across both clinical operations and strategic sales to identify new areas for growth within the company. www.frontagelab.com. To learn more , please visit our website - Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence. https://www.rad-md.net/, To learn more , please visit our website - PANEL DISCUSSION: The concept of DCT, is it the future? Exploring the idea of adopting a medical device-like regulatory philosophy/strategy for bringing drugs forwards, with a focus on antimicrobials, Industry is on high alert for bacterial outbreak, with parallels to the covid pandemic. Drivers of failures, Flawed clinical study design leading to failures, Diagnostic indicators and early Go/No-Go decisions in proceeding further during clinical study phases. In this presentation we will discuss the following: Clinical development has shifted from a scientifically driven journey to a patient-focused one. The company specializes in end-to-end services supporting drug discovery, precision medicine and clinical development for smarter clinical studies. We have been driving the success of our clients, consultants, and employees in staffing and consulting services since 2004. To learn more , please visit our website - www.promedica-intl.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. 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. 2 nd Clinical Case Reports Conference. 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. He has been actively involved on both sides of the business in managing CDMOs and CROs. 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. . Kris OBrien is an Executive Director in Program Strategy, specializing in Rare Disease and Pediatrics, at Premier Research. 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. She has a unique perspective in leading clinical programs in a dynamic startup environment. Philips BioTel Research is an industry leader in medical imaging and cardiovascular safety testing for clinical trials. 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. The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. May 3 - May 4 @ Barcelona, Spain. ARENSIA is based with its headquarters in Dsseldorf, Germany, and operates with 400+ talented employees in 7 countries, To learn more , please visit our website - To learn more , please visit our website - To learn more , please visit our website - www.pro-ficiency.com. Dr Frances Rubenstein has worked in clinical data management for more than 20 years in both medical device and pharmaceutical companies. Cognizing & mitigating Does AI-ML offer a solution? www.viroclinics.com. 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? WHAT TO EXPECT FOR 2023? To learn more , please visit our website - A healthy discussion on different disciplines in pre . His father was a physician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. Why should we collect Sexual Orientation and Gender Identity in Clinical Research Studies? This conference will explore the latest regulatory updates, global clinical trials, advanced technologies and more. Datacubed Health is a pioneering technology company making better science and healthier communities a reality. In addition, 30% of trial participants drop out of the study, Innovation should strive to maximize the synergy of all three variables: safety, efficacy, and speed. 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. He is an advisor to several biotech companies. This conference intends to focus on the global health and clinical trials around the world. Wendi is currently the Executive Director, Global Medical Affairs Evidence Generation COE at BioMarin Inc. where she oversees global operational strategy and execution for programs in the post-approval setting. Clinical Trials Innovation Programme 2023 is the only platform to . Estela has worked in healthcare for over 30 years, currently supporting private practices with electronic medical records, office workflows to help the practice and patients for a top leading healthcare organization. https://www.anjusoftware.com/, To learn more , please visit our website - Erin has over 20 years of clinical trial and pharmaceutical software technology experience . Dr. Marszewska has experience with electronic data capture and data management in clinical research. Improving communication, relationships and work-life balance with your internal team as well as partners. To learn more , please visit our website - Proven ability to organize and manage late-stage development cross-functional teams completing projects on time with meticulous attention to detail. Previously she served as Head of Clinical Outsourcing and Analytics for BioMarin Pharmaceuticals, where she was responsible for vendor contractual, relationship and financial management. Conduct of clinical trials are increasingly becoming expensive. Employee turnover continues to impact global market for talent. Sun, 24 Apr 2022, 09:00 End. To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com. He played a pivotal role in the development and commercialization of Veltassa (USA and EU), a treatment for hyperkalemia, Intermezzo for MOTN insomnia, Kerydin for onychomycosis, and Eucrisa for atopic dermatitis. Best practices and tools for managing supplier governance and ascertaining who is accountable, Identifying the criteria to determine level of oversight needed for a vendor. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals. Triomics is a technology company offering an enterprise-grade platform for clinical trial sites to automate data collection practices. Reimbursement for medical devices in trials, and, understanding the process. 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. Arena International are delighted to announceOutsourcing in Clinical Trials West Coastwill be returning to Burlingame for the annual event onMarch 1st& 2nd2023! www.Clario.com, To learn more , please visit our website - Conferences. Attendees. Emmes acquired Casimir in March 2022, and the . www.flexdatabases.com. EVENT - DIA Global Pharmacovigilance and Risk Management Strategies Conference. To learn more , please visit our website - www.gobio.com/clinical-research/. https://www.advancedclinical.com/. For more than 40 years, Emmes has been dedicated to research for a healthier world. https://www.muralhealth.com/. 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. Anju is a portfolio company of Abry Partners serving the worldwide pharmaceutical, biotech and contract research Life Sciences markets. THE 2023 AI UPDATE AI & disruptive technology: Harnessing the future of Artificial Intelligence to transform clinical trials, FIRESIDE CHAT: Overcoming the barriers to trial innovation and technology access from a small companys point of view. 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. 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 . Collaterally with her Regional Food and Drug Director duties, Anne served as the acting program director for both the Biologics and Tobacco programs during significant planning phases for program alignment. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. Dr. Hsu is anesthesiologist and pain management physician, but also a serial entrepreneur. 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. At Medable, she works cross-functionally with engineering, product development, regulatory, AI/ML, and data science to develop first-in-class DCT solutions. Other companies he has founded or co-founded include: 1) IMTH, a real estate investment trust with properties through the state of California; 2) iPill Dispenser, a medical device that uses a mobile app to control a secure, stand-alone pill dispenser to prevent opioid sharing, diversion, and drug overdoses; and 3) NAOMI systems, a practice management software company that integrates digital X-rays devices in PACS, EMR and RCM billing modules. GENENTECH CASE STUDY LGTBQ+ Health Inequities & SOGI collection Why collecting this data is important in your study, Uncovering how Deconstructed Patient Navigation can enhance patient support. Sections. 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. 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. To learn more , please visit our website - Hear from the trial industry as they discuss the services they would like to see from their solution providers, including: Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. . To learn more , please visit our website - 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. 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. Our goal each day, every day is to make sure our partners have whatever they need when and where they need it to execute a successful clinical trial, while also minimizing delays, unnecessary costs, and surprises. To learn more , please visit our website - 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. Medrio has extensive experience in all study phases and leads the market in early-phase trials. Estela is an exceptional community engagement liaison for both English and Spanish speakers. Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. Are you attending Outsourcing in Clinical Trials West 2023 conference? Online event and networking. CROMSOURCE operates offices across Europe and North America. CISCRP staff is committed to participating and presentingspeaker, chairperson, moderator, advisor rolesin relevant and engaging educational events within the clinical research industry. 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. Prior to starting SageMedic, he was an Associate Professor at UCSF. The global clinical trials outsourcing market size is expected to reach USD 67.62 billion by 2030, according to a new study. I am passionate about the life sciences and the clinical and commercial potential of novel therapeutics and applications of synthetic biology. San Diego Marriott La Jolla. AWT Healthcare manufacturers clinical trial labels. To learn more , please visit our website - 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. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services. Any Disease. Global Clinical Trials Connect 2023 2022 London United Kingdom. www.emvenio.com, To learn more , please visit our website - 2022 looks to be a bumper year too, so Nature Medicine asks leaders in their field what they think . Per the FDA, Decentralized Clinical Trials (DCT) hold promise to reduce patient and sponsor burden and increase accrual and retention of a more diverse trial population, Designing clinical trials with technology in mind can empower and power studies. ICON plc is a world-leading healthcare intelligence and clinical research organisation. Scalable, Reliable. To learn more , please visit our website - 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. Learn more about and Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp. Dr. Parapiteva is an experienced regulatory professional with over 24 years in the pharmaceutical industry/clinical research organizations. Read more. Solution-oriented professional, with strong problem solving capabilities. http://www.conversis.com/, To learn more , please visit our website - 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. Specializing in clinical development and staffing solutions, we offer a flexible approach to ensure our clients unique needs are supported. INTERACTIVE SESSION Data matters in health outcomes and equity: Collecting and understanding Social Determinants of Health (SDOH) data in clinical trials and beyond. RadMD, a Medica Group Company, is your full service imaging core lab solution. This conference will focus on topics such as bioethics, regulations, patient recruitment, site selection, data integration & strategy, and many more. His current work focuses on deep collaboration with an interdisciplinary team of engineers and scientists to successfully integrate data from multiple assessments and sensors, implement high-dimensional feature engineering, and both evaluate as well as apply scalable machine learning algorithms. Advantages of working alongside grass root organisations and PAGs what groups are out there? 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. 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. ), pharmacovigilance and safety solutions, translation and language services, and call center support. Read more. 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. 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. http://www.labconnectllc.com/. 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. Our Sponsor Edition includes dedicated applications for clinical study planning and budgeting, outsourcing and forecasting. Contact us for more information and for a live demo tailored to your use case and needs. Over the past 30 years his focus has been in the areas of drug substance as well as drug product R&D, manufacturing and outsourcing the small molecules as well as biologics. 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. 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. Conversis is built on one goal: To provide you with the highest-quality clinical trials translations. 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. The must attend clinical outsourcing event in the Southeast region where industry professional can encounter a platform to explore new solutions to common issues within their clinical trial. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, To learn more , please visit our website - https://www.medidata.com/. Wednesday, 28th Sep 2022 - Thursday, 29th Sep 2022 . 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. Tickets. http://strategikonpharma.com, To learn more , please visit our website - Medocitys platform is the only solution that provides a fully interactive clinical trial ecosystem enabling early decision making and safety monitoring in real time. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018.
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