Technology as a methodology: Accelerating Clinical Development timelines. 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. Developing successful communication pathways in a more remote world. Estela Mata is the President and co-founder of Looms for Lupus, a non-profit organization that provides Lupus, Fibromyalgia and Mental Health Awareness, advocacy, and support to those living with these conditions, their loved ones, and caregivers. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact by driving quality, mitigating compliance risk, and enhancing patient engagement. Advarra advances the way clinical trials is conducted to make them safer, smarter, and faster. Booth #4. You might have known us as Myoderm as we have recently changed our name but not our high-quality services as the complete clinical trial supply partner. www.orbisclinical.com. 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. April 18-20, 2016 Dubai, UAE. Additionally, our tech-enabled trial management system, streamlined study startup processes, centralized pre-screening call center, and unparalleled approach to patient recruitment will successfully deliver a superior CRO experience. To learn more , please visit our website - 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. Philips BioTel Research offers global operational support for cardiovascular monitoring in all therapeutic areas, and advances imaging services in oncology, cardiovascular, metabolic, musculoskeletal, neurologic, and medical device studies. Proven ability to organize and manage late-stage development cross-functional teams completing projects on time with meticulous attention to detail. March 14 . Visit our website to learn more about how we deliver a Better Clinical Experience. Since 2003, Conversis has supported our life sciences clients to successfully and effectively communicate with patients and medical professionals worldwide. https://www.anjusoftware.com/, To learn more , please visit our website - AliveCor is a privately-held company headquartered in Mountain View, Calif. Consumer or Personal ECGs are ECG devices available for direct sale to consumers. This holistic self-service platform provides faster data access and intelligent analytics, empowering clinical trial teams to think innovatively. Currently, Audrey Funwie works in the Patient Inclusion and Health Equity team of Genentechs Chief Diversity Office. This session examines how scientific rigor can be applied to clinical outcome assessments (COAs) even though they are subjective. Anju Software is a customer-first organization providing adaptable life science solutions for clinical research, medical affairs, and data science. Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. She is a Nurse Practitioner by training and spent over 10 years caring for patients before coming to industry. CLOSING KEYNOTE: FDAs role in maintaining a secure and resilient supply chain. http://www.yprime.com/, To learn more , please visit our website - 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. He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning. Our Ergomed team is looking forward to exhibiting at Outsourcing Clinical Trials - Texas 2022, December 7th & 8th . I am the CEO at OrPro Therapeutics, a biotechnology company in San Diego, CA developing biologic drug solutions to unmet needs in serious epithelial diseases including cystic fibrosis. Keeping them can be an even bigger challenge. 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. He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. AI-ML, a Hype or Hope. Sandy Mohan is the VP of Quality at Iovance Biotherapeutics. To learn more , please visit our website - Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. 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. Sun, 24 Apr 2022, 09:00 End. To learn more , please visit our website - The 2014 event will focus on how companies from the region can implement effective clinical outsourcing strategies. His thesis was on the role of the Androgen Receptor in Hormone Refractory Prostate Cancer. 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. Read more . He was Senior Director of Clinical Operations at Pharmacyclics from 2012 to 2017 where he was responsible for the development, implementation and maintenance of the Clinical Operations infrastructure, as well as the GCP inspection hosting platform and processes, and regulatory authority marketing approval inspection hosting. She has a wealth of knowledge and experience having served more than 24 years in ORA managing staff and operations focused on medical devices, radiological health, and MQSA. Anju is a portfolio company of Abry Partners serving the worldwide pharmaceutical, biotech and contract research Life Sciences markets. Last year alongside talks from industry leaders Pfizer, Bristol Myers Squibb, [] 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. Our high-caliber project management, clinical monitoring, medical safety, data management, biostatistics, regulatory affairs and quality assurance capabilities make us a valued partner. What things do they need a partner to do and what they dont need! Henry is a Vice President of Data Sciences at Medidata. 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. With locations in the US and EU, Catalyst offers highly flexible and customized, customer-centric solutions from Global Resourcing and FSP, to Full Service Managed Solutions, with a focus on oncology product development. 2023 edition of Outsourcing in Clinical Trials East Coast will be held at King of Prussia starting on 23rd May. 85356 Mnchen-Flughafen , Join NAMSA 5-6 April in Munich, Germany for Outsourcing in Clinical Trials: Medical Devices Europe. . Dr. Apfel is a California licensed physician with 20+ years of clinical experience in anesthesiology, critical care medicine, and emergency medicine. Contact: ESMO Registration Office; Phone: [+41 (0) 91 973 19 13]; Email: registration@esmo.org. Commercial Services. Any Disease. Powered by the IQVIA CORE, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. From 1990 to 2008 he held various Clinical Operations positions at Abgenix, Pharmacyclics, Quintiles, Covance and Syntex. To learn more , please visit our website - Over 20 years in clinical research, including patient innovation, feasibility, strategy, patient recruitment, retention, site engagement. March 1 - March 2,2023 Outsourcing in Clinical Trials West Coast. He investigated mechanisms by which active ingredients in cumin seeds halt Prostate Cancer progression and metastasis at the Vattikutti Urology Institute, Henry Ford Hospital. Joined industry with a goal of developing digital and devices to improve patient care. KEYNOTE: Seeing your site as a partner and identifying best practices for reducing site-burden, Seeing your site as a partner and identifying best practices for reducing site-burden, Clinical Operations leader with extensive bio-pharmaceutical and CRO industry experiences (20+years) *Develop and implement strategic Clin. To learn more , please visit our website - As specialists in clinical regulatory documentation, we provide a service that is more than just writing. http://greenphire.com/. To learn more , please visit our website - www.flexdatabases.com. It is a 2 day event organised by Arena International Events Group and will conclude on 30-Nov-2022. ACM performs more than 20 million laboratory tests each yearspanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more. The DPO Centre has assisted over 600 clients globally, including a broad range of bioscience, genomics, therapeutics, healthcare and pharma companies to comply with EU data protection laws such as the GDPR, the EU Clinical Trials Regulation and specific member state requirements. ClinChoice is a leading full-service clinical CRO offering high-quality solutions to pharmaceutical, biotechnology, medical device and consumer products clients. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. She has managed and overseen large global clinical trials in various therapeutic areas and multiple phases of development. 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. Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc. 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. Phase 1 Trials: How to globalize to accelerate value inflection. She has over 22 years of experience overseeing GxP quality and compliance for all phases of drug development for biologics and small molecules. To learn more , please visit our website - Focusing on life sciences, Datacubed offers software and services driven by behavioral science to improve patient retention and compliance, resulting in better data and positive health outcomes. 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. Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. March 07-09, 2016 Madrid, Spain. Looking forward to another great conference! Clinical Chemistry & Laboratory Medicine Conference. 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. She has an extensive background including several years of experience in field medical as well as over 6 years in medical affairs. Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. CROMSOURCE operates offices across Europe and North America. The DPO Centre isEuropes leading life science experts, providing Data Protection Officer (DPO) and Data Protection Representative (DPR) services. Project Leader, Health Equity And Population Sciences, Hoffman La Roche. To learn more , please visit our website - Dr. Debashish Niyogi is currently Vice President, Product Management at Anju Software, where he is responsible for the vision, strategy, and roadmap for the companys eTMF and CTMS solutions. Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Casimir's research on the development of the Duchenne Video Assessment (DVA) scorecards was published in PLOS ONE. To learn more , please visit our website - To learn more , please visit our website - 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. 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 . Zigzag aims to provide straightforward, reliable and flexible Quality Assurance and auditing services on a local or global basis. 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. http://www.dsg-us.com/. She has extensive experience in managing complex projects, with a strong focus on building and maintaining relationships at both company and industry level from an operational role within the organization. 30+. To learn more , please visit our website - 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. She has led clinical development in dermatology and medical aesthetics for pharma/biotech, CROs, medical device and cosmetic companies including RAPT, Innovaderm, Premier Research, Allergan, Leo Pharma, and Murad. Improving the patient experience through user-focused design. 7 - 9 November 2022, Amsterdam . https://www.intrinsequehealth.com/. Worldwide is changing how the world experiences CROs in the best possible way. Kunal has over 18 years of experience managing and conducting clinical trials. 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. 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. 4G Clinical, a leader in randomization and trial supply management (RTSM) for the global life sciences industry, is sponsoring the 2022 Outsourcing Clinical Trials DACH. 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. 12 years at Parexel. To learn more , please visit our website - To learn more , please visit our website - https://www.anjusoftware.com/. Headquartered in Sydney since 1996, Novotech has come to be recognised as the CRO of choice for many US and European biotechnology firms in the Asia Pacific. Whether you require ad hoc support or a team to partner with on audit programs, we have the people, the expertise and the experience to provide the assistance you need. 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. Drivers of failures, Flawed clinical study design leading to failures, Diagnostic indicators and early Go/No-Go decisions in proceeding further during clinical study phases. TICKETED. 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. Where do the opportunities lie for further acceleration in clinical development? ICON plc is a world-leading healthcare intelligence and clinical research organisation. Since 1996, ARA has supported 700+ clinical trials worldwide across all therapeutic areas. Join us in Philadelphia, May 10th-11th, to shape best practice on: Refining patient recruitment strategy. Emvenio Research is transforming how patients and care-givers engage in and experience clinical research, To learn more , please visit our website - Medocitys platform captures valuable real-time clinical insights & real-world data, while engaging patients, sites, and sponsors. 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! Mr. Larwood is the third of his family to be involved in Valley Fever. Each nurse is trained, tested, and certified as a Certified Mobile on an annual basis in the principles of clinical trial research, GCP, Nurse Guidelines and IATA. 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. 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). We have five years of clinical trial experience and capabilities around the globe in over 90 countries and across any therapeutic area whether for decentralized, hybrid or fully virtual studies. Caroline Cooper is the Director of Clinical Operations at CymaBay Therapeutics, Inc. with over 10 years of experience in clinical research. For more than 20 years, Axiom has delivered data-driven, powerful and cost-effective eClinical Solutions and Services dedicated to small-to-medium life science companies. Brandi Coffin has been in the medical device industry for over 15 years with various roles in post market surveillance, quality, compliance and patient safety. . Proven track record of coordinating teams in order to meet tight deadlines, set and communicate expectations, and manage deliverables. This is the unmissable event that the pharmaceutical, biotechnology, and medical device communities need to come together and discuss strategies for operational success in clinical trials. This is also a critical time to determine the development strategy for later study phases. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine. Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence,Worldwide Clinical Trialsprovides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

Nick O'malley Wedding, Gianni Bini Over The Knee Rhinestone Boots, Robert Morse Bridge Investment Group Net Worth, Articles O