outsourcing in clinical trials conference 2022

Novotech is an Australia based clinical CRO operating across Asia and South Africa. Why drugs fail in clinical trials? 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). Anju Software is a customer-first organization providing adaptable life science solutions for clinical research, medical affairs, and data science. How do we move forward from here? 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. CLOSING KEYNOTE: FDAs role in maintaining a secure and resilient supply chain. 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. Dan Solisfrom TheFDAwill give the closing keynote. Choose from over 15 fully integrated modules on a single platform: EDC, DM, RTSM/IWRS, CTMS, Inventory Management, ePRO, eConsent, Patient Portal, AE/SAE Tracking, Safety Database, Central/Local Lab, Imaging Management, eTMF, and 24/7 Project and Clinical Data Reporting. RadMD, a Medica Group Company, is your full service imaging core lab solution. To learn more , please visit our website - To learn more , please visit our website - Working closely with the CRO and giving your site the freedom to breathe, Communication is key- how can the sponsor/CRO help and support as a partner, Trends in clinical development across the globe over the last 5 years, Pre and post covid impact on the clinical trial global economy, Patterns in investment and clinical trial equity. Register. To learn more , please visit our website - In partnership with customers, we build solution-driven teams working for a healthier future. Our experienced project managers and global network of linguists are supported by proven processes and cutting-edge technology. 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. She is currently the Founder and CEO of Strategikon Pharma, developer ofClinical MaestroTM, the industrys only end-to-end cloud-based platform for clinical trial budgeting, sourcing and budget management including strategic alliance/partnership management. As the IPM, he is the District liaison to FDA Headquarter handling import related issues and concerns. Meghan serves as the VP, Clinical Trial Financial Management at Medidata driving roadmap and strategy across our Grants Manager and Site Payments products. 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. 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. Outsourcing in Clinical Trials Southeast . Imaging endpoints are often used to support go/no-go decision-making in early phase trials. http://greenphire.com/. OCT DACH Conference 2022 - Outsourcing in Clinical Trials. Dr. Richard Abelson, President & CEO of Statistics & Data Corporation (SDC), founded the company in November of 2005. www.eclinicalsol.com. Contact us for more information and for a live demo tailored to your use case and needs. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv. Founded in 1996, ProTrials has been successfully supporting clinical research for over 25 years. Saamas unified, AI-driven clinical data analytics cloud platform seamlessly integrates, curates, and animates unlimited sources of structured, unstructured, and real-world data to deliver actionable insights across all therapeutic areas. Datacubed applies innovative solutions for the capture of active and passive data for engagement with patients in in-person, hybrid, or fully virtual clinical studies. Our specialized experts drive scale, innovation, and speed to market for visionary clients around the world. Session Reserved for Worldwide Clinical Trials, Data Management: Programming and metrics in medical device studies, Vast experience of over 20 years in Quality, Regulatory, Processes Improvements and leading cross organization projects, VP Quality Assurance, Regulatory Affairs and Clinical at IceCure Medical, since September 2020, leading the company compliance and clinical affairs, Prior to joining IceCure Medical, held a position of Director of Quality, Regulatory and Customer Support at Applied Spectral Imaging (ASI) and Several positions at Carestream Health (formerly Orex Computed Radiography). . As the worlds largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture. 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. Founded in 2005, the companys cloud-based EDC, Direct Data Capture, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. Our customized and scalable solutions improve the quality and execution of clinical trials while mitigating costs and allowing clients to retain strategic control. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. http://www.augustresearch.com/. To learn more , please visit our website - She also has worked within the clinical department at several reputable companies like Axogen, Medtronic, Coloplast and CR Bard. Home / Events /. 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. His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today. Taking a Data Science approach to gain financial oversight of clinical trials. Precision for Medicine (PFM), the full-service global CRO, is purpose-built to accelerate clinical research and development processes to bring life-changing therapeutics to those who need them most. WORKSHOP: Identifying and overcoming the hurdles associated with global studies including longer timelines, drawn-out budgets and remote teams. https://www.discoverinternational.com/. https://www.muralhealth.com/. Tactical clinical operations in digital health studies, First-hand learnings, breakthrough device system, a case study. Last year alongside talks from industry leaders Pfizer, Bristol Myers Squibb, [] Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. Pharmaceutical Development. Meghan joined a CNS-focused start up in RTP and has spent the last 15+ years working in the life science technology industry. Advantages of working alongside grass root organisations and PAGs what groups are out there? 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. Bringing together nearly 700 professionals, TFS delivers tailored clinical research services in more than 40 countries. We're here at the Outsourcing in Clinical Trials & Clinical Trial Supply East Asia conference. Conduct of clinical trials are increasingly becoming expensive. Our Precision Matching software mines millions of patient records, including unstructured physician notes, to pin-point eligible study patients in real-time. www.rad-md.net. 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. deep6.ai, To learn more , please visit our website - Spaulding Clinical Research is a global CRO providing Phase I IV drug development services to pharmaceutical and biotechnology companies. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionalscollaborateswith biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Company Website:https://eurofinscentrallaboratory.com/biopharma-services/, To learn more , please visit our website - March 1 - March 2,2023 Outsourcing in Clinical Trials West Coast. https://www.anjusoftware.com/, To learn more , please visit our website - http://www.altasciences.com/, To support the acceleration of drug development, over the last 12 years, ARENSIA Exploratory Medicine GmbH (www.arensia-em.com) has built up its own research clinics, with full Phase I infrastructure, entirely dedicated to the performance of sophisticated FIRST-in-PATIENT Phase IB, IIA and PROOF OF CONCEPT clinical trials with novel compounds. To learn more , please visit our website - November 13-14, 2023 Dubai, UAE. 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. Dr Jankicevic holds Doctor of Medicine degree, Master of Medical Sciences degree, and Board-certification in Dermatology and Venereology from the University of Belgrade, Serbia. 1333 Bayshore Highway, Burlingame, dpocentre.com. To learn more , please visit our website - Acceleration of clinical development in the worlds fastest growing region, Biotech Market Performance and the impact on Clinical Trials and Operations. She is a Registered Respiratory Therapist, holds the CPPS (Certified Professional in Patient Safety) credential from IHI and has a Masters degree from Johns Hopkins in Patient Safety and Healthcare Quality. Theyll ensure your translations will be of the highest quality, on time, and within budget. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve live. Partnerships in Clinical Trials Europe 2020. 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. Dr. Apfel is also the Chair of Life Sciences at the Keiretsu Angel Investment Forum, where he invests in life-science companies that have the potential to positively impact patients with serious conditions. Dr. Karl McEvoy has over a decade of industry experience in both the vendor and sponsor sides. Chief Executive Officer, Agility Pharmaceuticals, Dr Mishra (Ex Genentech, Ex NCI, Ex NIH) is the founding president and CEO of the American Association for Precision Medicine ( and chair of ACT AAPMs Coronavirus Taskforce He is leading research efforts focused on preventing curing chronic diseases not only treating the sick but also providing knowledge/tools to individuals to live longer, healthier lives He is also the founder and CEO of Agility Pharmaceuticals, a pharmaceutical company committed to revolutionizing drug discovery development through technology, big data, robotics, and artificial intelligence He is a serial entrepreneur who founded his first company after graduating high school, and his second company during his Ph D Since then, he has accumulated a wealth of experience by building, investing, and advising numerous other companies He is an investor, co founder/ board member of a few corporations, focused on accelerating drug discovery/ development, data analytics, robotics, mental health, and digital health He is also the founder of AAPM Angels and Investors AAi an investment group focused on investing in drug discovery, diagnostics, precision medicine, technology healthcare companies He is also the founding investor and advisor to Barcelona Ventures and serves as an advisor to a 100 M private equity fund Widely recognized as a thought leader in the field of technology and healthcare, Dr Mishra has keynoted, chaired, curated, and organized numerous successful international conferences He served as a Scientist and Principal Investigator at the pharma giant Genentech, Roche Where he participated in several drug discovery project teams Moreover, his passion for drug development and precision medicine has led to the identification of new drug targets, biomarkers, companion diagnostics, and several drugs/ combinations in the clinic His research work has been recognized globally by over 40 prestigious awards and honors Due to his unique perspective selfless service, he is a highly respected sought after mentor to many The companies that he has advised have raised multimillion dollars Notably, he serves as a mentor and advisor to several VC funds and startup accelerators, including IndieBio HIMSS/Health 2 0 s Project Zygote, MedLabs ZGC Capital, J&J JLabs UCSF Innovation Venture, UCSF Invent Fund, and California Life Sciencess FAST program, to help grow Californias life sciences innovation ecosystem, Chief Executive Officer, Strategikon Pharma. This conference is always a great opportunity to share and learn with our colleagues across the industry. Her clinical development experience spans all therapeutic areas and all stages of the clinical development lifecycle, from natural history studies through registrational global trials, and Long-Term Follow Up and Post Marketing surveillances. The 2014 event will focus on how companies from the region can implement effective clinical outsourcing strategies. Our experts are ready to discuss how our solutions can best support your live studies. He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. Dr. Cunningham came from academic background. Prior to joining Iovance she served as the VP of Quality at Immune Design which was acquired by Merck. 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. Our mission is to eliminate the barriers to clinical trials by bringing access to people where they live, work and are willing to engage. 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. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. 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. Their services include clinical monitoring, clinical monitoring oversight, clinical trial management, data management, biometrics, and medical writing. Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. David Hadden is the pioneer of AI-driven Virtual Patient Simulation technology. To learn more , please visit our website - Alexis Garelli has over 15 years of diverse healthcare information and pharmaceutical software technology experience. 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. Improving communication, relationships and work-life balance with your internal team as well as partners. Catalyst Clinical Research is a new generation Clinical Research Organization, serving the unique needs of small-to-medium sized biopharmaceutical companies. Ms. OBrien has been conducting clinical research for more than 35 years and has covered multiple functions during that time. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals. To learn more , please visit our website - Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. Estela has worked in healthcare for over 30 years, currently supporting private practices with electronic medical records, office workflows to help the practice and patients for a top leading healthcare organization. She serves as an advisor for early phase study teams in developing inclusive clinical trials. He has been actively involved on both sides of the business in managing CDMOs and CROs. 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. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. Clinical Trials conferences 2023 are large-scale multidisciplinary events well attended by clinical researchers, media partners, renowned speakers, sponsors, scientists, exhibitors, and other attendees. Currently, Audrey Funwie works in the Patient Inclusion and Health Equity team of Genentechs Chief Diversity Office. To learn more , please visit our website - Understanding Social Determinants of Health: Identifying the variables that burden trial participants how can we collect this data? The elluminate Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources. 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. To learn more , please visit our website - Outsourcing Clinical Trials New England 2022. To learn more , please visit our website - http://www.pcmtrials.com/. At Strategikon Pharma, we bring a high level of precision and speed to outsourced clinical trial operations through our flagship SaaS platform, Clinical Maestro. For over 35 years Parexel has been a trusted global clinical research organization (CRO) and biopharmaceutical services company. In her role at Nevro, Frances is responsible for leading the data management team, driving the adoption of new technologies and innovative data management processes to bring new treatments to patients. With presentations and panel discussions on the top industry trends and outsourcing challenges, and . www.iqvia.com. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018. With over 40 years experience, 600 beds and locations in NA, EU and Asia, Celerion conducts First-in-Human, clinical Proof-of-Concept and patient dose response studies, cardiovascular safety and NDA-enabling clinical pharmacology research. UPCOMING EVENT. To learn more , please visit our website - We atMyonexadd value to our clients by helping them always be prepared for what is next in their clinical trials. www.kardia.com. www.curebase.com, To learn more , please visit our website - Intrinseque Health is an EN ISO 13485 certified Global Clinical Supply Chain organisation, building & executing complex Clinical Supply Plans for Ancillary, Medicinal products, Clinical Supplies, Equipment and Services required by Pharmaceutical & Biotech companies and CROs for their Clinical Trials. www.ACMGlobalLab.com. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials. How do you arrange with and clean the large amounts of data generated? Compare and contrast the FDA, MHRA and TGA regulatory requirements for Phase I clinical entry. To learn more , please visit our website - We are committed to delivering high-quality, cost-effective services according to sponsor timelines and specifications. The conference is tailor-made to address the concerns of trial sponsors based in Texas who are conducting . TransPerfect Life Sciences specializes in supporting the global development and commercialization of drugs, treatments, and devices designed to improve and save lives. 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. 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. 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. Study sponsors and contract research organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. To learn more , please visit our website - 200+. Precision medicine is in our blood, our cells, our genes, and our name. Dr. Apfel is an internationally known authority on designing, conducting, and publishing highest quality clinical trials with thousands of patients that have changed medical practice with over 100 peer-reviewed publications. In his role as BD lead, he is responsible for many aspects of the companys planning and operations. Global Player in eClinical Solutions . Emmes acquired Casimir in March 2022, and the . ARENSIA is based with its headquarters in Dsseldorf, Germany, and operates with 400+ talented employees in 7 countries, To learn more , please visit our website - Altasciences full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, data management and more, all of which can be tailored to specific sponsor requirements. They have fewer surprises, faster outcomes, and stronger data integrity. Ellen Weiss is the Vice President, In-Home Solutions, Decentralized Clinical Trials at PCM Trials. At Trilogy, medical writing is our passion. She has authored or co-authored 10 publications and has been an advocate for STEM education throughout her career. Arena International are delighted to announceOutsourcing in Clinical Trials West Coastwill be returning to Burlingame for the annual event onMarch 1st& 2nd2023! www.frontagelab.com. CA; X-Mine, CA; Delphian Pharma, CA and Certum LLC, CA). 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. Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget . Orbis Clinical is a leading global life science recruitment partner. Actalent is a leading provider of Clinical and Laboratory services. View Event. Having worked within all major biopharma markets including USA, Japan, China, EU and Australia has enabled him to become a trusted advisor to many customers and help them achieve their clinical drug development objectives. To learn more , please visit our website - This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. . A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers. Executive Director, Clinical Outsourcing and Alliance Management, BridgeBio Pharma, Inc. VP Digital Transformation Strategy, Medable, Sr. Director, Clinical Operations NGM Bio, Vice President, Drug Development, Alto Neuroscience, VP Clinical Trial Financial Management, Medidata, Product Director, Decentralised Trial Technology at YPrime, Health Technology - Clinical Research, Meta, Director, eCOA Science & Consulting, Clario, Associate Director, Quality Culture Excellence, Ultragenyx Pharmaceutical, Solutions Consultant, eClinical Solutions, Associate Director of Clinical Operations, CymaBay Therapeutics, Associate Director, Global Regulatory Clinical Services, Global Outsourcing Director, Development Operations, Ascendis Pharma, Sr. Clinical Operations Professional, Imago BioSciences, Senior Director Of Clinical Affairs , Materna Medical, RN, MSN, CCRC, CCRA, Senior Manager of Clinical Affairs and Field Operations Ancora Heart, Deputy Program Director, Office of Medical Devices and Radiological Health Operations (OMDRHO), ORA, FDA, Director, Global Clinical Shared Services at Stryker Neurovascular, Vice President Of Clinical Affairs, Endogenex, Director, Clinical Programs, Clinical Affairs, ReCor Medical, Director, Database Management, Nevro Corporation, Director Global Patient Safety- Device And Digital Health, AstraZeneca, Medical Director, Patient Safety Physician Digital & Devices, AstraZeneca, VP Quality Assurance, Regulatory Affairs And Clinical, IceCure Medical, Vice President, Product Management, Anju Software.

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