Reimbursement for medical devices in trials, and, understanding the process. She is currently managing a Ph3 program in rare liver disease. Understanding Social Determinants of Health: Identifying the variables that burden trial participants how can we collect this data? www.Clario.com, To learn more , please visit our website - To learn more , please visit our website - Oversight with less presence how to make this work, Effectively building strong working relationships remotely, Strategies to deliver training and upskill your team, Handling hard discussions with your CRO/partner when you cant meet in person, Optimizing communication channels/effectiveness with your CRO partner and team, Maintaining a positive working relationship prioritizing and building strategies from the outset, Clinical trial timelines are lengthy and on average a Phase 3 trial can take between 1-4 years. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. NikZ shows promise against other important fungal diseases. Cliniacal Trials 2023 | 13th International Conference on Clinical I am very excited to be attending Clinical Outsourcing Group UK this year in London! clinical trials Conferences 2023/2024/2025 is for the researchers, scientists, scholars, engineers, academic, scientific and university practitioners to present research activities that might want to attend events, meetings, seminars, congresses, workshops, summit, and symposiums. Communities. This event is a great opportunity to get to know the online casino players who will be [] ACM Global Laboratories is one of the largest global independent central labs in the industry. How best to go about educating the patient community? Mr. Larwood is the third of his family to be involved in Valley Fever. https://www.chillipharm.com/. eCOA is our core focus but not our only service. https://www.muralhealth.com/. Can you share some of your workflow procedures? GxPs in Cell Therapy and key considerations for Quality and Project Management. . 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. Our Australian phase I facilities are in Melbourne and Brisbane, and our US phase I facility is located in Minneapolis. 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. 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). Currently, Audrey Funwie works in the Patient Inclusion and Health Equity team of Genentechs Chief Diversity Office. Advarra integrated solutions connects life sciences companies, CROs, research sites, investigators, and academia at the intersection of safety, technology, and collaboration. 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. ICACB 2023: Applied Clinical Biostatistics Conference, Rio de Janeiro (Feb 16-17, 2023) ICAHIPHIM 2023: Advanced Healthcare Informatics and Public Health Informatics Management Conference, New York (Feb 16-17, 2023) ICCPP 2023: Clinical Psychiatry and Psychology Conference, Barcelona (Feb 16-17, 2023) ICEPNR 2023: Exercises for Pediatric . Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. Dr. Apfel is a California licensed physician with 20+ years of clinical experience in anesthesiology, critical care medicine, and emergency medicine. 2023. Keeping them can be an even bigger challenge. Our commitment to excellence, innovative technologies, and therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. To learn more , please visit our website - https://lifesciences.transperfect.com/. 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. This enables earlier submissions with the potential of coming to market sooner and recovering R&D investments ahead of projections. Stop by to see us at Outsourcing in Clinical Trials New England 2021 conference. We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. www.zigzagassociates.com. Top Pharma Events and Biotech Conferences in 2023 | Scilife To learn more , please visit our website - Weve all had to sit through several pitches from vendor companies telling us what they can do for us, but now its time to reverse the conversation! Improving communication, relationships and work-life balance with your internal team as well as partners. During her career she has supported Class 1-3 devices through the entire product lifecycle. Best practices for managing CRO governance for small/start-up companies with limited resources or large companies with competing priorities, Driving success in either unexplored settings or in saturated market settings, Maintaining Chain of Identity/Chain of Custody, Evolving Technologies & Regulatory Guidance documents, Roel of Project Management in helping to drive and streamline cross functional communication, Key considerations for communicating timelines and milestones, Maintaining focus on Quality centric culture, Using machine learning to increase efficiency, Leveraging interoperability to streamline operations. Anju Software is a customer-first organization providing adaptable life science solutions for clinical research, medical affairs, and data science. Arena International are delighted to announceOutsourcing in Clinical Trials West Coastwill be returning to Burlingame for the annual event onMarch 1st& 2nd2023! Current topics in the Medical Device Regulatory Landscape, Presented by the FDA. ClinOne, a leader in virtual clinical trial management, provides a single platform technology experience to accelerate clinical trial enrollment and remote patient care, compliance and retention. Rhonda has more than 30 years of experience in FDA, starting as an ORA Investigator in Portland, OR before becoming a manager located in FDA's Minneapolis office. His thesis was on the role of the Androgen Receptor in Hormone Refractory Prostate Cancer. Medrio has extensive experience in all study phases and leads the market in early-phase trials. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. She has a unique perspective in leading clinical programs in a dynamic startup environment. Our leading clinical show will focus on providing delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials, this is an [] Anne came to FDA in 1990 with an undergraduate degree in Biochemistry and a masters degree in Food Science and segued into FDAs laboratory science regulatory operations. www.prevailinfoworks.com. To learn more , please visit our website - actalentservices.com, To learn more , please visit our website - The impact DCT has on diversity, equality and inclusion (DEI) have we finally managed to tap into under-represented communities? Outsourcing In Clinical Trials - Texas 2022 - Ergomed PLC By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience. ), pharmacovigilance and safety solutions, translation and language services, and call center support. Explore and learn more about Conference Series : World's leading Event Organizer. This conference will explore the latest regulatory updates, global clinical trials, advanced technologies and more. 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. Consulting Dermatologist, Clinical Development & Medical Affairs RAPT Therapeutics, Inc. 2 nd Clinical Case Reports Conference. Flex Databases platform is a secure, unified and compliant system for clinical trials. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners most high-profile drug and device programs. From 2008 to 2011, he was Senior Clinical Trial Manager at Seattle Genetics where he was responsible for the oversight of multiple oncology clinical trials, as well as support for the development of the Clinical Operations infrastructure and regulatory authority marketing approval inspection hosting. By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Parexel is among the worlds largest clinical research organizations (CROs), providing the full range ofPhase I to IV clinical development services to help life-saving treatments reach patients faster. The conference will bring together pharmaceutical and biotech experts to connect and explore solutions to current challenges associated with clinical trials. To learn more , please visit our website - Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. With 2,000 annual trials and projects, around 200 active clients and global access to source drugs in over 60 countries,Myonex is your complete partner around clinical trials around the globe reliable, trusted and by your side. To learn more , please visit our website - He started his career with FDA in 1998. What can small biotech ClinOps teams learn from large Pharma, and vice versa? Precision medicine is in our blood, our cells, our genes, and our name. 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. After completing her education in England, Ndidi began her career working for Parexel followed by Merck Sharp & Dohme. Conference . 1333 Bayshore Highway, Burlingame, Outsourcing in Clinical Trials Europe 2023 - Arena International CISCRP Conferences - Clinical Research Industry Medidata is leading the digital transformation of life science, with the worlds most used platform for clinical development, commercial, and real-world data. To learn more , please visit our website - 7th Decentralized & Hybrid Clinical Trials - Dynamic Global Events To learn more , please visit our website - https://www.threadresearch.com/. http://www.peachtreebrs.com. https://www.threadresearch.com/, To learn more , please visit our website - He is a key member of the leadership team responsible for defining the company's go to market strategy and value proposition across the many segments of the pharmaceuticals and device research industry. 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). On the Calendar | PharmaVoice To learn more , please visit our website - http://www.iconplc.com/. 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. She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. http://strategikonpharma.com, To learn more , please visit our website - We are focused on helping our clients to address their most significant and complex drug discovery and development challenges. For over 25 years, Altasciences has been integrating into clients projects to help support educated, faster, and more complete early drug development decisions. To learn more , please visit our website - Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. Novotech is an Australia based clinical CRO operating across Asia and South Africa. Data-driven operations and oversight with elluminate. 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. To learn more , please visit our website - www.clincierge.com. After years of watching the opioid crisis develop, John has developed an innovative drug and dispenser to safely treat pain and deter abuse. 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. www.ledgerrun.com/, To learn more , please visit our website - Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone. 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. Erin has over 20 years of clinical trial and pharmaceutical software technology experience . 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 . www.clinone.com, To learn more , please visit our website - 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. 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. Proven track record of coordinating teams in order to meet tight deadlines, set and communicate expectations, and manage deliverables. Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. WHAT TO EXPECT FOR 2023? Ms. Lea is the Director of Global Patient Engagement and Advocacy for Acceleron, a wholly-owned Subsidiary of Merck. Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. We provide personalized patient logistics management, reimbursement, and convenience services to support clinical trial participants. News; . Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. Tactical clinical operations in digital health studies, First-hand learnings, breakthrough device system, a case study. To learn more , please visit our website - August, 2023. To learn more , please visit our website - He also conducted undergraduate research on osteoporosis progression and has authored several papers, abstracts and a book chapter on protein signal transduction. www.signanthealth. Advance Research Associates is a premier provider of biostatistical and data management services to the pharmaceutical, biotech, and medical device industries. What are global biotech executives asking/concerned about when evaluating Phase I study plans? As a Solutions Consultant with eClinical Solutions, Dan serves as a subject matter expert for the elluminate Clinical Data Cloud, the foundation of digital trials. BS in Human and Organizational Behavior, and Communication Studies and authored numerous trade articles and frequently present on behalf of Parexel at trade conferences. 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. Or has the noise around DCT quietened? We are a certified Minority Business and always do the right thing. FDAs role in maintaining a secure and resilient supply chain. Acceleration of clinical development in the worlds fastest growing region, Biotech Market Performance and the impact on Clinical Trials and Operations. To learn more , please visit our website - 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 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. Translational Drug Development (TD2) is a world-class oncology drug development organization specializing in the development of new oncology medicines. Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. To learn more , please visit our website - To learn more , please visit our website - Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. IRT Interactive Response Technologies - Informa Connect 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. Using modern payment, transportation, and communication solutions we help drive retention, compliance, and data quality. Conduct of clinical trials are increasingly becoming expensive. To learn more , please visit our website - http://www.endpointclinical.com/. Meghan joined a CNS-focused start up in RTP and has spent the last 15+ years working in the life science technology industry. AbbVie reports rise in full-year 2022 net revenues; Teva Pharmaceutical reports 5% fall in Q4 2022 revenue; Merck reports 2% increase in worldwide sales in Q4 2022; Companies. Our simulation-based protocol training prevents study errors, guarantees timely SIV, and frees up thousands of hours for your study team and site-staff. About Mobile Technologies in Clinical Trials.