outsourcing in clinical trials conference 2022

To learn more , please visit our website - Digital health technologies and biomarkers in clinical trials requires the highest standards of data collection, transmission, security, quality, and analysis. 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. Arun received a Bachelors degree in Biological Sciences from University of California-Riverside, a Masters degree in Biomedical Sciences from Wayne State University and completed Doctoral degree coursework from Michigan State University College of Human Medicine. Richard holds a Ph.D. in Industrial Engineering with a focus on applied statistics, quality, and reliability engineering from Arizona State University (ASU), a Master of Science in Industrial Engineering focused in Operations Research and Production Systems (ASU) and a Bachelor of Science in Engineering in Industrial Engineering (ASU), and is certified as a Six Sigma Black Belt. Our specialized experts drive scale, innovation, and speed to market for visionary clients around the world. The Patient Engagement track will be chaired byEstela Mata-Carcamo(Healthcare Advocate) and will delve into topics such as,outreach to minority groups,social determinants of health, and best practices forengaging the patient community. 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. Prior to joining Iovance she served as the VP of Quality at Immune Design which was acquired by Merck. At Strategikon Pharma, we bring a high level of precision and speed to outsourced clinical trial operations through our flagship SaaS platform, Clinical Maestro. April 28-29, 2016 Dubai, UAE. Tickets. 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. Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence. 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. 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. Choose from over 15 fully integrated modules on a single platform: EDC, DM, RTSM/IWRS, CTMS, Inventory Management, ePRO, eConsent, Patient Portal, AE/SAE Tracking, Safety Database, Central/Local Lab, Imaging Management, eTMF, and 24/7 Project and Clinical Data Reporting. Translational Drug Development (TD2) is a world-class oncology drug development organization specializing in the development of new oncology medicines. Ms. OBrien has been conducting clinical research for more than 35 years and has covered multiple functions during that time. To learn more , please visit our website - http://www.pcmtrials.com/. Conference series LLC Ltd Organizes 3000+ Global Events Every Year across . 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 - David Hadden is the pioneer of AI-driven Virtual Patient Simulation technology. https://www.discoverinternational.com/. Regional Director, Business Development, Novotech, Executive Vice President Business Development, Nucleus Network, VP of Clinical Development, Rani Therapeutics, VP of Clinical Operations, CymaBay Therapeutics, Inc, Associate Director, Clinical Operations, Santen, Senior Lead, Global Compliance and Strategy, Medidata, Therapeutic Strategy Lead, Gene Therapy Think Tank, Worldwide Clinical Trials, Vice President, Quality Iovance Biotherapeutics, Vice President, Program Management, Iovance Biotherapeutics, Head of Product, Trial Interactive, TransPerfect, M.A. Global Clinical Trials Connect 2023 2022 London United Kingdom 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. Fusion eClinical Suite is the most adaptable, unified platform that serves as the Connected Hub for all your Clinical Trial and operational data and reporting. Reem enjoys working in startups bringing forward long-term vision and strategies. TICKETED. There, he employed a broad range of methodologies, including: visual psychophysics, neuropsychological and computer-based cognitive assessments, eye tracking, electrophysiology, and structural imaging. To learn more , please visit our website - https://www.anjusoftware.com/. 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. What should we be doing now to anticipate, prepare, prevent and respond? Saama Technologies is the advanced clinical data and analytics company, unleashing wisdom from data to deliver better actionable business outcomes for the life sciences industry. Diagnostic Services. Rho, a contract research organization (CRO) located in Chapel Hill, NC, provides a full range of services across the entire drug development process. To learn more , please visit our website - CISCRP staff is committed to participating and presentingspeaker, chairperson, moderator, advisor rolesin relevant and engaging educational events within the clinical research industry. 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. 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. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. https://www.calyx.ai, To learn more , please visit our website - Clinical research professional with 25 years of experience in clinical and medical affairs, most recently as Director of Clinical Affairs and Associate Director of Medical Affairs for a global medical device manufacturer focusing on endovascular and surgical repair of aortic disease. What can small biotech ClinOps teams learn from large Pharma, and vice versa? From 7 to 9 November 2022. The 2022 program boasts two full streams including: The two day, in person conference, Outsourcing in Clinical Trials will deliver top-quality content from industry experts covering all aspects of operational . Clinical Outcome Assessments (COAs): Applying scientific rigor and good instrument design. This is also a critical time to determine the development strategy for later study phases. Session Reserved for Worldwide Clinical Trials, Data Management: Programming and metrics in medical device studies, Vast experience of over 20 years in Quality, Regulatory, Processes Improvements and leading cross organization projects, VP Quality Assurance, Regulatory Affairs and Clinical at IceCure Medical, since September 2020, leading the company compliance and clinical affairs, Prior to joining IceCure Medical, held a position of Director of Quality, Regulatory and Customer Support at Applied Spectral Imaging (ASI) and Several positions at Carestream Health (formerly Orex Computed Radiography). https://www.worldwide.com, To learn more , please visit our website - Specifically for Clinical Trials and RWE studies, Medocitys modular and flexible architecture ensures swift configuration and deployment in less than 4 weeks, through a fully interoperable and connected SaaS cloud database. Find out about the events you can meet the Caidya team at and stay updated about the latest conferences and clinical research events. We are focused on helping our clients to address their most significant and complex drug discovery and development challenges. www.frontagelab.com. To learn more , please visit our website - 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. Lin, who has been with the company since October 2016, previously served as the Senior Vice President of Sales and Marketing. WCG measurably improves the quality and efficiency of clinical trials, helping biopharmaceutical companies, CROs, and institutions facilitate the development of new treatments and therapies for patients. www.viedoc.com. Sandy Mohan is the VP of Quality at Iovance Biotherapeutics. www.zigzagassociates.com. August, 2023. 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. Over the course of his career, he has worked on clinical development of 23 compounds currently marketed in 1 or more therapeutic indications. Founded in 2005, the companys cloud-based EDC, Direct Data Capture, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. Since 1996, ARA has supported 700+ clinical trials worldwide across all therapeutic areas. http://www.premier-research.com/, To learn more , please visit our website - We look forward to welcoming you In-Person to Amsterdam for Clinical Trials Europe 2022 to celebrate our 21st birthday. Going the last millimeter: What you may not know about home visits. Join thought leaders from regulatory agencies, biotech, pharma, patients, and academia to discuss the latest advances, challenges, and forward-thinking . Explore and learn more about Conference Series : World's leading Event Organizer. 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. Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. Arena International are delighted to announce Outsourcing in Clinical Trials West Coast will be returning to Burlingame for the annual event on March 1st & 2nd 2023! AI-ML, a Hype or Hope. Founded in 1976, ACRP is a Washington, DC-based non-profit organization with more than 13,000 members who work in clinical research in more than 70 countries. Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). Review market analysis on location of Phase I studies and discuss why these choices are made. Triomics is a technology company offering an enterprise-grade platform for clinical trial sites to automate data collection practices. Employee turnover continues to impact global market for talent. Frances has an undergraduate degree in Physiology and a PhD in medical science from the University of Sydney. We provide personalized patient logistics management, reimbursement, and convenience services to support clinical trial participants. She has authored or co-authored 10 publications and has been an advocate for STEM education throughout her career. 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. Global Clinical Trials Connect 2023 2022 London United Kingdom. PANEL DISCUSSION: The concept of DCT, is it the future? Founded and operated as a more customer centric and nimblealternative to traditional CROs, KPS offers a full range of services leveraging the latest clinical technologies. For more information please contact Graig Daley Business Development Manager and Jackson Young Business Development Associate atsales@citlabels.com. Their experienced research team comprises key opinion leaders, board-certified cardiologists and radiologists, sub-specialty scientists, and highly trained technicians who acquire, evaluate, and report high-quality data through an efficient, cloud-based infrastructure. 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. 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. 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. In a separate article, Manasi Vaidya discovers that, fuelled by the successful use of mRNA vaccines in Covid-19, RNA therapeutics are expected to make larger strides in 2022.. Based on available data, there are emerging trends . To learn more , please visit our website - ClinChoice is a leading full-service clinical CRO offering high-quality solutions to pharmaceutical, biotechnology, medical device and consumer products clients. We will synthesize the scientific practices underpinning good instrument design and COA data collection methods and recommend next steps for addressing data collection challenges. Funwie strives to do meaningful work that combines and applies her bioethics background while prioritizing and addressing health equity in the context of clinical studies, patient experience, and policy. http://www.yprime.com/, To learn more , please visit our website - Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. Infectious disease clinical trials; Biometrics functional outsourcing; We also provide: Drug development consultancy and services to assist the development plan of molecules in early clinical phases; Clinical pharmacology units, bioanalytical laboratories and trial management offices across Europe and North America to perform your clinical . Wayne holds an MBA and B.S. 12 years at Parexel. Featuring solutions for automated referrals, eConsent, patient engagement, connected devices, eCOA, and eSource, ClinOne makes participating in a clinical trial a little easier, every day. To learn more , please visit our website - To learn more , please visit our website - www.pro-ficiency.com, To learn more , please visit our website - To learn more , please visit our website - Read more. Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget . Debashish earned a PhD in Computer Science from the State University of New York at Buffalo, specializing in the application of AI techniques in document analysis. 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. Dr. Apfel is an internationally known authority on designing, conducting, and publishing highest quality clinical trials with thousands of patients that have changed medical practice with over 100 peer-reviewed publications. Register. http://www.arensia-em.com/. Advarra advances the way clinical trials is conducted to make them safer, smarter, and faster. As a community leader and healthcare advocate she partners, collaborates with initiatives including the U.S. Department of Health and Human Services Office of Minority Health and the U.S. Food and Drug Administrations Office of Minority Health and Health to increase awareness on the need for diversity in lupus clinical trials, All Of US Research, Scripps Digital Trials Center and Congresswoman Grace Napolitanos Mental Health Consortium. 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. Combining OCT, CTS and Medical Devices events, this is the perfect platform for professionals from . 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? as a Microbiologist, HQ position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import Operations Branch. Meghan serves as the VP, Clinical Trial Financial Management at Medidata driving roadmap and strategy across our Grants Manager and Site Payments products. At Medable, she works cross-functionally with engineering, product development, regulatory, AI/ML, and data science to develop first-in-class DCT solutions. 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. His goal is to help you accelerate your clinical research career and be a more effective leader. The company specializes in end-to-end services supporting drug discovery, precision medicine and clinical development for smarter clinical studies. Gordon Chu is the Director of Investigations Branch at the Food and Drug Administration (FDA) Division of West Coast Imports (DWCI) within the Office of Enforcement and Import Operations (OEIO). 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. We offer both single modules and a unified solution to maintain all processes you can cover all existing software needs with only one vendor. We are a patient-centric tool utilized to decrease the burden of clinical trial participation. Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. 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. Medocitys platform captures valuable real-time clinical insights & real-world data, while engaging patients, sites, and sponsors. She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. Day 1 will kick off with a talk on designinga playbook for how to handle an undesirable CRO-Sponsor partnership, followed by a Keynote Panel allowing attendees to debate how to optimize theiroversight & governance, led byAbby Kennedy(VP of Clinical Operations, CymaBay Therapeutics). News; . Are you planning to attend the upcoming Outsourcing in Clinical Trials New England, November 9-10th, 2021? She is also a Certified Clinical Research Professional, and a trained journalist. Long term solutions: could reducing the site certification process be a realistic solution? He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. 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. www.advarra.com. AliveCor is a privately-held company headquartered in Mountain View, Calif. Consumer or Personal ECGs are ECG devices available for direct sale to consumers. I will be there with my colleague Georgi Govedarov, come visit us at booth Isidora Teodorovi on LinkedIn: I am very excited to be attending Clinical Outsourcing Group UK this year He worked as a Research Associate to improve recruitment metrics in the Million Veterans Program genomic biobanking initiative for Loma Linda VA Medical Center where he developed a novel Point of Care recruitment solution in outpatient clinics. Taking place in Boston, 17 - 19 October 2022. How best to go about educating the patient community? Our experts are ready to discuss how our solutions can best support your live studies. Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. Advance Research Associates is a premier provider of biostatistical and data management services to the pharmaceutical, biotech, and medical device industries. Their services include clinical monitoring, clinical monitoring oversight, clinical trial management, data management, biometrics, and medical writing. PANEL DISCUSSION: Decentralized/Hybrid Trials: Discussing the current challenges and debating best practises for a successful virtual study, Considerations and best practices in direct-to-patient (DTP) / decentralized clinical trials (DCT) lessons learned from past trials, PANEL DISCUSSION: Reversing the Conversation What the clinical trial industry really wants from its service providers, KEYNOTE A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around, A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around. DCT was previously done out of necessity but are we seeing it as a new world order? From 2 to 4 November 2020. Strategy/Planning: How do you make the decision to run a DCT; what are the considerations? 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. For over 35 years Parexel has been a trusted global clinical research organization (CRO) and biopharmaceutical services company. Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. Ms. Lea is the Director of Global Patient Engagement and Advocacy for Acceleron, a wholly-owned Subsidiary of Merck. In 2021, ERT and Bioclinica merged to become Clario creating the broadest endpoint technology platform in the industry and enhancing our scientific expertise. SDC delivers top-tier clinical trial services to pharmaceutical, biologic and device/diagnostic companies. His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever. This event is a great opportunity to get to know the online casino players who will be performing at this meeting. For more information, please contact us at 262-334-6020, or via email at Daniel.Selness@spauldingclinical.com. 200+. To learn more , please visit our website - To learn more , please visit our website -

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