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. Aug 09 International Conference on Drug Development, Clinical Trial Phases and Technology (ICDDCTPT) - Lagos, Nigeria. Advice for the ClinOps team to avoid unnecessary patient visits, how does your protocol affect the site? 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. Her experience in a multitude of therapeutic indications has led to an acute knowledge of study conduct and execution with a keen focus on protocol dynamics. www.greenlightclinical.com, To learn more , please visit our website - Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible. SCOPE 2022 attracted more than 2,300 leaders in clinical operations and research and all conference tracks will feature best practice case studies relevant to clinical operations experts and those new to the field. Datacubed Health is a pioneering technology company making better science and healthier communities a reality. To learn more , please visit our website - www.careaccess.com. 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. By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Conferences. Overview | The Conference Forum GxPs in Cell Therapy and key considerations for Quality and Project Management. This conference is always a great opportunity to share and learn with our colleagues across the industry. East Coast Clinical Trials Conference | New York US - 03-04 May 2023 Our specialized experts drive scale, innovation, and speed to market for visionary clients around the world. 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. Clinical Trials Europe - Informa Connect 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. Liza has extensive experience in managing and overseeing phase I-IV clinical trials globally as well as building and growing clinical operations teams in oncology, cardiovascular, metabolic and liver diseases, HIV and trials in gene therapy. Long term solutions: could reducing the site certification process be a realistic solution? To learn more , please visit our website - The report gives a detailed insight into current market dynamics and . 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. 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. www.signanthealth. 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. Kristina leads the Patient Insights team at Parexel and is dedicated to bringing a thorough understanding of the patient journey, and the patient voice to the entire spectrum of research services. For the past 10 years, Estela has co-facilitated support groups, led, and participated in educational symposiums, advocated locally and nationally. 2022 looks to be a bumper year too, so Nature Medicine asks leaders in their field what they think . Quickly upscaling digital technologies. 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. 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. The Budget Conundrum. 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 enquire about sponsorship opportunities for the conference, please contact: To enquire about speaking opportunities for the conference, please contact: Arena International is a global B2B events company for online casino players. Last year alongside talks from industry leaders Pfizer, Bristol Myers Squibb, [] March 14 . She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. The last decade of this time has been solely focused on the investigator grant administration domain driving strategy and leading teams implementing payment technology in both BPO and enablement models. This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences. TFS demonstrates scientific and medical competence across populations and therapeutics, with industry-leading capabilities in: -Dermatology, Immunology and Inflammatory Diseases, -Internal Medicine including Neurology & Respiratory, -Pediatrics, Rare Diseases and Orphan Drugs, Detailed information about TFS, and its business offerings can be obtained through. PANEL DISCUSSION: The concept of DCT, is it the future? Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. Sun, 24 Apr 2022, 09:00 End. We develop new innovations, drive emerging therapies forward and improve patient lives. Axiom Exhibiting at Outsourcing in Clinical Trials West Coast 2023 http://www.axiommetrics.com/. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine. Find out about the events you can meet the Caidya team at and stay updated about the latest conferences and clinical research events. Our Provider Edition offers a CRO costing module and bid benchmarking. Tickets. Conduct of clinical trials are increasingly becoming expensive. 5 th Clinical Nutrition Conference. Amy has been a drug discovery and development professional for 25+ years, including progressive roles in clinical operations and clinical strategy. The Technology track will seeKimberley Ferguson(Commercial Head of Personalized Healthcare Partnerships, Genentech) discussing all thingsWearables. We atMyonexadd value to our clients by helping them always be prepared for what is next in their clinical trials. Dr. Parapiteva is an experienced regulatory professional with over 24 years in the pharmaceutical industry/clinical research organizations. Optimizing CRO Success: Relationship, contribution and oversight, PANEL DISCUSSION Defining your outsourcing strategy to contain costs and accelerate drug development time-to-market: what should you consider in the new COVID-19 era, Executing clinical trials on a shoestring: Optimizing the CRO Functional Service Provider model. Clinical Outcome Assessments (COAs): Applying scientific rigor and good instrument design. 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. DCT was previously done out of necessity but are we seeing it as a new world order? Our digital solutions enable sites to be more productive, with online study training, study eBinders (eISF), digital study alerts and SUSARs, patient visit guides, and a wide range of study tools, available via web portals and mobile apps. Advantages of working alongside grass root organisations and PAGs what groups are out there? 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. in Psychology and Biology from the University of California at Santa Cruz. Altasciences helping sponsors get better drugs to the people who need them, faster. https://www.rad-md.net/, To learn more , please visit our website - 21 October 2022 Outsourcing In Clinical Trials - Texas 2022. Complimentary. NikZ shows promise against other important fungal diseases. April 28-29, 2016 Dubai, UAE. Project Leader, Health Equity And Population Sciences, Hoffman La Roche. www.advarra.com. Clinical Trials Outsourcing Global Market Report 2022: Clinical Trial Conferences 2023 - mcdougallscientific.com We're here at the Outsourcing in Clinical Trials & Clinical Trial Supply East Asia conference. She has held key national leadership roles including advisor within the Obama/Biden administrations global HIV response team, advisor to United Nations leadership and instructor at the CDC and USAID. 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. FDAs role in maintaining a secure and resilient supply chain. Chris has dedicated his 16-year career to the services side of the Phase I clinical drug development industry, including both operational and business development roles. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. 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. 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. He also served on multiple FDA Headquarter working group and committee related to Food Safety Modernization Act (FSMA), import process improvement, strategic framework, rapid screening technology, and partnership agreements. 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. http://www.labconnectllc.com/. http://www.datacubed.com/. 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. Prior to joining Iovance she served as the VP of Quality at Immune Design which was acquired by Merck. To learn more , please visit our website - To learn more , please visit our website - Outsourcing in Clinical Trials Southeast 2023 - Arena International To learn more , please visit our website - The company serves over 600 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients. 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. Review and assess the selection criteria sponsors face when selecting Phase I jurisdiction. What can we do to take advantage of high prevalence of disease in populous countries but systems are either rudimentary or non-existent? 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. Outsourcing In Clinical Trials East Coast 2022 - HealthManagement.org We offer Bioanalysis for small molecules and biologics for PK, immunogenicity and biomarkers utilising the platforms of LC-MS/MS (7) and Immunoassay (MesoScale, Gyrolab). Driven by a unique combination of deep domain expertise and technical capabilities, our ClinRun application suite rethinks trial administration through active engagement, smart design, and breakthrough technology. 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. 28 - 29. He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. November 28-30, 2016 San Antonio, USA. To learn more , please visit our website - http://www.medable.com/. . He is an advisor to several biotech companies. Booth #4. 30+. As a CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. A healthy discussion on different disciplines in pre . To learn more , please visit our website - Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. His teams mission is to build scalable data science and engineering software services that are integrated into Medidata platform to accelerate the generation of actionable insights across the clinical development lifecycle. Decentralized Clinical Trials 2023 Event - Informa Connect Partnerships in Clinical Trials Europe editions. www.ACMGlobalLab.com. To learn more , please visit our website - Helping you take advantage of the speed of study start-up and R&D tax incentives in Australia and allow for smooth trial transition in the US. https://www.sdcclinical.com/. http://www.arensia-em.com/. 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. http://www.clindatrix.com/. Isabel Brown (she/her) currently works on the Inclusive Research and Health Equity team for Genentech's Research and Early Development, Clinical Operations group. Combining medical expertise and deep industry knowledge, we develop bespoke solutions to accelerate your innovative treatment development for patients with unmet needs, one trial at a time. Decentralized Clinical Trials 2022 was a really good opportunity to . In this presentation we will discuss the following: Clinical development has shifted from a scientifically driven journey to a patient-focused one. View Event. Inspire is a vital health community where more than two million patients and caregivers feel comfortable sharing personal health data, experiences, and answering questions candidly. She has extensive experience in building quality organizations, overseeing Phase 3 global clinical trials, supporting marketing authorization applications in the US and EU, and managing pre-approval inspections leading to multiple product approvals and launches. To learn more , please visit our website - http://www.iconplc.com/. 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. Tranquil Clinical Research is an early phase CRO with a fully accredited Hospital Phase I unit. At Pro-ficiency, Dave has transformed clinical research training into a powerful study resource and analytics tool, and Pro-ficiency has become the leader in the proactive, metric-driven approach to training that contradicts the traditional, check-it-off-the-list approach. Promedica International is a privately held, full-service CRO providing clinical trial services for the medical device, biotechnology and pharmaceutical industries. Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideasinto reality. OMDRHO's Key Initiatives, inspectional and compliance activities, Define RWE and real-world data sources/needs, Making progress during pandemic for a first-in-human device study, Designing a hybrid trial for a novel interventional device, Navigating the complexities of multi-specialty study, Determining the technologies to move studies off site in order to move forward with the new norm, Investigating technology to save costs and improve accuracy of pharmacokinetic and pharmacodynamic data, Learning how to improve study drug adherences so only the study participant has access and, can only take the drug as per study protocol, Case Study looking at Digitization for objective data and cost saving, Defining the reimbursement strategy to prove medical benefit and value, Understanding codes for medical device technologies, Working with the FDA to secure your reimbursement, Programming for efficient data management, Generating metrics for data tracking and study progress, Overview of how we interface with our organization, Discussing the technologies accessible for the smaller biotechs, Assessing how to make access to innovations affordable for companies on a smaller budget and how to best allocate limited resources, How to work with a vendor partner as a smaller biotech to get access to new technologies, Removing the barriers: what still needs to be done to improve access to innovation for all, Key drivers for trial enrolment and in time completion, Population and high prevalence of disease in developing countries, Barriers and hurdles to access vast pool of patients, Strategies/solutions to penetrate through barriers and pass hurdles, Common operational, security and regulatory issues around the collection, management, and reporting of essential clinical trial documents, How eTMF solutions can help to address these issues, and ensure inspection-ready and regulatory compliant storage of trial content, How eTMF solutions reduce business risk, improve team collaboration and productivity, reduce auditing and reporting costs, and ensure enhanced artifact quality, Major capabilities that current eTMF solutions should provide. Catalyst Clinical Research is a new generation Clinical Research Organization, serving the unique needs of small-to-medium sized biopharmaceutical companies. Network with 600+ clinical peers. To learn more , please visit our website - He started his career with FDA in 1998. 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. Meet Inspiring Speakers and Experts at our 3000+ Global Events with over 1000+ Conferences, 1000+ Symposiums and 1000+ Workshops on Medical, Pharma, Engineering, Science, Technology and Business. To learn more , please visit our website - In addition to her deep understanding of the unique dynamics of developing novel treatments for rare and complex diseases, Dr. Raymond also leverages her combination of training and experience leading the Gene Therapy Think Tank at Worldwide Clinical Trials. https://www.trilogywriting.com/. Rhonda Mecl recently became the Deputy Program Director after serving as the Program's Operations Staff Director for the previous five years. Services are available in U.S., Canada and ROW. Of the several programs he worked at Pharma and Biotech companies, three culminated in making to the market [PaclitaxelTM Bristol-Myers Squibb; SensiparTM Amgen and DuexisTM - Horizon Therapeutics). Emmes news, press releases, announcements 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. 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. CROMSOURCEis unparalleled in offering an end-to-end guarantee covering trial timelines, enrollment, and price. Founded in 1985, Promedica International, a woman-owned corporation, is headquartered in Orange County, California. Dr. Apfel is a California licensed physician with 20+ years of clinical experience in anesthesiology, critical care medicine, and emergency medicine. 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. Dr. Cunningham came from academic background. This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. To learn more , please visit our website - http://www.premier-research.com/. She has managed and overseen large global clinical trials in various therapeutic areas and multiple phases of development. Global Clinical Trial Outsourcing Market Report 2022: Increasing Medrio has extensive experience in all study phases and leads the market in early-phase trials. The 2023 program boasts 4 full streams jam packed with content: It was very interesting, both the presentations and the meeting opportunities. Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible. 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. 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. His most recent activity is as CEO and Founder of QuiVivePharma, a company he took from inception to a FDA face-to-face PreIND meeting in just 1 year. This session examines how scientific rigor can be applied to clinical outcome assessments (COAs) even though they are subjective. This, exclusive event brings together attendees from established pharma, large and small, alongside with biopharmaceutical companies and gives opportunity to dive into the operational challenges and innovations in clinical development found within the UK & Ireland region. How best to go about educating the patient community? For more than 40 years, Emmes has been dedicated to research for a healthier world. Global Clinical Trials Connect 2023 2022 London United www.clinone.com, To learn more , please visit our website - Global Clinical Trials Connect 2023 2022 London United Why expert partners and staff matter; what metrics dont tell. 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. www.versiticlinicaltrials.org, Viedoc designs engaging software for the life science industry. To learn more , please visit our website - 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. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone. Lin holds a Master of Science in management from the Stanford University Graduate School of Business and a master's in marine biology from Sun Yat-sen University in Guangdong, China. Michaels background spans contract and proposal development; contract negotiations in multiple languages; set up and management of vendor oversight and governance programs; and related change management. Partnerships in Clinical Trials Europe 2022. Dr. Raymond completed her doctoral training in molecular biology at University of California San Diego and post-doctoral training in molecular biology at Memorial Sloan-Kettering in New York City, New York, USA. Events | 4G Clinical CHI's Clinical Trial Innovation Summit Despite the ongoing disruptions from COVID-19, 2021 saw some major results from clinical trials. To learn more , please visit our website - Harbor Clinical, a WBENC-certified, women-owned company, provides a hybrid of services which ensure all aspects of clinical trials meet quality assurance and regulatory standards from study documentation, vendor oversight, and flexible resourcing throughout operations. eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. 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. The 2022 program boasts two full streams including: Cliniacal Trials 2023 | 13th International Conference on Clinical