http://www.clinicalink.com/, To learn more , please visit our website - Outsourcing in Clinical Trials Southern California 2022. http://www.rhoworld.com/. 85356 Mnchen-Flughafen , Join NAMSA 5-6 April in Munich, Germany for Outsourcing in Clinical Trials: Medical Devices Europe. Dr. Richard Abelson, President & CEO of Statistics & Data Corporation (SDC), founded the company in November of 2005. 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. Compare and contrast the FDA, MHRA and TGA regulatory requirements for Phase I clinical entry. 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. 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. 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. Care Access is a global research site that accelerates the availability of new treatments and therapies through our unique site infrastructure and ability to cultivate research-empowered communities. Long term solutions: could reducing the site certification process be a realistic solution? To learn more , please visit our website - What is critical to get right to make a digital QM System work? TORONTO, March 23, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions . She is driven by listening and incorporating the patient voice and by finding innovative ways to improve the patient experience. It is the go-to solution in over 1,000 sites and 40 countries enabling investigators and sponsors to simply record, review, anonymise and submit assessments to regulatory bodies. theactigraph.com. www.bsi-lifesciences.com. Trial enrollment accounts for 60% of the total time of the trial and for 80% of trial failures. She has executed a variety of clinical trials involving therapeutic areas including autologous breast reconstruction, heart failure, hypertension, arrhythmia management and erectile dysfunction. http://www.clindatrix.com/. Previously, Bruce held leadership roles at Alkahest, Celerion and Allon Therapeutics, and works closely with the Michael J Fox Foundation, chairing one of their scientific review panels. Mr. Luciano earned a B.A. Their services include clinical monitoring, clinical monitoring oversight, clinical trial management, data management, biometrics, and medical writing. The elluminate Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources. He also conducted undergraduate research on osteoporosis progression and has authored several papers, abstracts and a book chapter on protein signal transduction. Taking place in Boston, 17 - 19 October 2022. http://www.mlm-labs.com. Combined, our clinics offer over 200 beds. Vice President, Clinical Operations, Corvus Pharmaceuticals Inc. Assistant Commissioner for Import Operations, U.S. Food and Drug Administration, Director, Global Patient Engagement and Advocacy, Acceleron Pharma, Associate Director, Site Contracts & Budgets Deciphera Pharmaceuticals, LLC, Program Director, Office Of Medical Device And Radiological Health Operations, FDA. Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideasinto reality. 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. Were streamlining your research, helping you get to your next milestone faster. Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. The DPO Centre isEuropes leading life science experts, providing Data Protection Officer (DPO) and Data Protection Representative (DPR) services. To learn more , please visit our website - Wed, 25 May 2022, 18:00 WebSite. 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. www.medocity.com, To learn more , please visit our website - Deep 6 eliminates months of manual data validation, to de-risk and accelerate clinical trials, because clinical trials should be a gatekeeper (accelerator), not a bottleneck to innovation. Attendees. Any Disease. Stop by to see us at Outsourcing in Clinical Trials New England 2021 conference. To learn more , please visit our website - http://www.novotech-cro.com/. PANEL DISCUSSION THE PATIENT IMPACT: Patient recruitment, patient centricity & virtual trials Navigating the New Normal, QUICK FIRE ROUNDS: The Patient Perspective, Keynote Not just ticking a box: Outreach to minority groups is improving but the focus now is on establishing trust and relationships. Specializing in clinical development and staffing solutions, we offer a flexible approach to ensure our clients unique needs are supported. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. After years of watching the opioid crisis develop, John has developed an innovative drug and dispenser to safely treat pain and deter abuse. 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. 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. How best to go about educating the patient community? It is a 2 day event organised by Arena International Events Group and will conclude on 30-Nov-2022. Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. Dont miss out; join us in Burlingame on March 1st& 2nd2023! To learn more , please visit our website - Were a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. To learn more , please visit our website - https://www.parexel.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. View Event. BS in Human and Organizational Behavior, and Communication Studies and authored numerous trade articles and frequently present on behalf of Parexel at trade conferences. With nearly a decade of home visits learnings, Ellen has a unique perspective on how decentralized clinical trials have changed over the years and what the future looks like. Kris OBrien is an Executive Director in Program Strategy, specializing in Rare Disease and Pediatrics, at Premier Research. Learn more about and Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp. Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 3rd-4th May 2023! Global Player in eClinical Solutions . 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. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve live. Technology as a methodology: Accelerating Clinical Development timelines. April 18-20, 2016 Dubai, UAE. This event is a great opportunity to get to know the online casino players who will be performing at this meeting. Our Sponsor Edition includes dedicated applications for clinical study planning and budgeting, outsourcing and forecasting. Meghan McKenzie works in Patient Inclusion and Health Equity in Genentechs Chief Diversity Office. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services. David Hadden is the pioneer of AI-driven Virtual Patient Simulation technology. Clinical Trials 2022 will discuss various disciplines involved in the pre-clinical research, conduct of clinical trials; it will educate health care researchers about design, operation, organizing, research computing . My training is in genetics (Ph.D.) and mechanical/biochemical engineering (M.S. A visual cognitive neuroscientist by training, Dr. Anderson has over a decade of experience developing both hardware and software to evaluate behavioral and neural mechanisms of attention, working memory, and visual perception. Outsourcing In Clinical Trials . The report gives a detailed insight into current market dynamics and . 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. 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. https://lifesciences.transperfect.com/, To learn more , please visit our website - 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. ), pharmacovigilance and safety solutions, translation and language services, and call center support. Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. 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. To learn more , please visit our website - http://www.clinicalink.com/. 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. 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. Previously she served as Head of Clinical Outsourcing and Analytics for BioMarin Pharmaceuticals, where she was responsible for vendor contractual, relationship and financial management. She received her MS and PhD in Microbiology from New York University and did a postdoctoral research at Merck Research Laboratories. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. WHAT TO EXPECT FOR 2023? Our latest enhancements include patient genetic and biomarker matching to promote swift site identification and patient enrollment. BDO Releases 2022/2023 CRO Insights Report. Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. She is mastering the logistics of dosing and testing clinical trial participants where they live, work, and study. Pro-ficiency ensures that everyone in your study is compliant with all training requirements. With presentations and panel discussions on the top industry trends and outsourcing challenges, and . 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. Estela is an exceptional community engagement liaison for both English and Spanish speakers. http://www.dsg-us.com/. 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. 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. 2 nd Clinical Case Reports Conference. Amsterdam RAI. The Digital Transformation of Clinical Trials the Importance of Data Accuracy. 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. Ops components of various FIH studies and global P1-P3 drug development programs and post-marketing studies in Oncology, Hematology-Oncology, Immuno-Oncology, Infectious Diseases, Immunology, Metabolic Diseases, Ophthalmology, and Critical Care conducted in North America, Europe, Africa, Central and South Americas, Asia-Pacific regions including Japan, China, So Korea, and Australia *Lead cross-functional teams and successfully contributed to several INDs, NDAs, FDA, EMEA, TGA, and NMPA regulatory filings and approvals of marketed products within HIV/Virology Therapeutic Area *Mentor, motivate, and develop clinical operations teams and direct reports *Strong, flexible, strategic team leader with extensive change management successes *Track record to develop, problem-solve, and execute creative and innovative process improvements and quality efficiencies within development operations *Motivated and driven to continue contributing to drug development in transformative medicines with a focus on unmet medical needs, CLOSING KEYNOTE: ClinOps team focus: Managing relationships, retention and hiring in the new world. 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. To learn more , please visit our website - Dr. Cunningham came from academic background. The 2023 programme will offer a fresh insight into the latest regulatory updates, global clinical trials, advanced technologies such as digital health and connected devices space, and more. Please email me if you'd like to set up a meeting to discuss your upcoming clinical trials: Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence. Solution-oriented professional, with strong problem solving capabilities. Dr. Lindsay Hughes, Director of eCOA Clinical Science and Consulting at Clario, is a scientist and leader with over 15 years of experience in behavioral and life sciences. SDC delivers top-tier clinical trial services to pharmaceutical, biologic and device/diagnostic companies. She has over 22 years of experience overseeing GxP quality and compliance for all phases of drug development for biologics and small molecules. The DIA's Digital Technology in Clinical Trials Conference discovers how digital technology is transforming the drug, device, and diagnostics development process in clinical trials. 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 . Boring clinical trials are better clinical 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. Anne Reid is the Program Director of the Office of Medical Device and Radiological Health Operations (OMDRHO). We go beyond traditional events and offer, The main program of the conference is discussion and debate on the outsourcing of clinical research. Why the current state of trials makes it difficult for patients to participate in research, How and when to incorporate patient insights into your programs, How to create a business case to garner support for investing in solutions, The benefit for the study sponsor, and other stakeholders, for investing in solutions to make it easier to be a participant, Barriers to patient participation with a focus on the barrier that became the impetus of the model, Delving into benefits of Patient Navigators and challenges with consistent comprehensive support for patients, Exploring the Enhanced Patient Support Services, Cover proactive strategies to address performance risk and protocol deviations, How to apply performance data from simulation-based training to manage risk areas, Discuss how to interpret and apply learning results to optimize and de-risk your DCT, Rethinking your site management strategy to minimize overburdening sites, dependant on the phase of your study, Pinpointing how site turnover impacts the sponsor and how to help reduce it whilst keeping patient care front of mind. To learn more , please visit our website - Clinical Chemistry & Laboratory Medicine Conference. Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs. We will synthesize the scientific practices underpinning good instrument design and COA data collection methods and recommend next steps for addressing data collection challenges. He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning. Our full service offering includes clinical program management, biometrics services and regulatory affairs. Harness the power of video evidence in clinical trials with ChilliPharms compliant platform and suite of video services for filming, de-identifying and reviewing clinical outcome assessments. She became the Deputy Program Director for OMDRHO in 2017 and ultimately became OMDRHO Program Director in February 2022. He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. What can small biotech ClinOps teams learn from large Pharma, and vice versa? Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables. Parexel Recognized by Frost & Sullivan with 2022 Global Customer Value Leadership Award . For more information, visit http://www.saama.com. IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Scalable, Reliable. http://www.arensia-em.com/. This holistic self-service platform provides faster data access and intelligent analytics, empowering clinical trial teams to think innovatively. Over the years, Lin has achieved success at both large corporations and startups. Commercial Services. With a dual clinical appointment in Robotic-Surgery at the Institute, Arun focused on post-surgical outcomes of Da-Vinci Robotic Prostatectomy for Hormone Refractory Patients. GxPs in Cell Therapy and key considerations for Quality and Project Management. Ms. OBrien has been conducting clinical research for more than 35 years and has covered multiple functions during that time. Prior to working at Genentech, she graduated from the Johns Hopkins Bloomberg School of Public Health with a Master of Bioethics. Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. Topics: Improving the patient experience through user-focused design. The Decentralized Clinical Trials hybrid event, April 18th - 20th in Boston, will provide leading insights and practical guidance on how to decentralize your clinical trials for greater diversity, accessibility and efficiency, with guidance a world-class speaker line up. Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. 6 th Clinical & Forensic Pathology Conference.

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