Making progress of a complex Interventional device study during covid. Join thought leaders from regulatory agencies, biotech, pharma, patients, and academia to discuss the latest advances, challenges, and forward-thinking . Explore Modern RTSM Solutions. From 2 to 4 November 2021. To learn more , please visit our website - AWT Healthcare manufacturers clinical trial labels. CISCRP staff is committed to participating and presentingspeaker, chairperson, moderator, advisor rolesin relevant and engaging educational events within the clinical research industry. ESMO TAT, known as "The Home of Phase I in Oncology", is the leading congress focusing on promising new anticancer targets and agents, with a particular emphasis on those in early phase clinical development. 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. Pro-ficiency ensures that everyone in your study is compliant with all training requirements. For over 25 years, Altasciences has been integrating into clients projects to help support educated, faster, and more complete early drug development decisions. He received his medical degree (MD) and his doctoral degree (PhD equivalent) from Justus-Liebig-Universitt Giessen, Germany, and his Master of Business Administration (MBA) from the Wharton School of Business, University of Pennsylvania, PA. Kunal Sampat is the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. Conference . Supported by top pharmaceutical and biotech partners across 20 different therapeutic areas, Care Access is scaling and globalizing its new model for clinical trial delivery, where more physicians and patients can engage in life-saving research to develop new therapies faster. How do you arrange with and clean the large amounts of data generated? Over 20 years in clinical research, including patient innovation, feasibility, strategy, patient recruitment, retention, site engagement. To learn more , please visit our website - Stream B: Clinical Innovation & Technology, A Fireside Chat on. 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. The "Global Clinical Trial Outsourcing Market by Clinical Trial Phase, Therapeutic Area, End-user and Region: Competition Forecast and Opportunities to 2027" report has been added to . To learn more , please visit our website - Amsterdam RAI. deep6.ai, To learn more , please visit our website - http://www.rhoworld.com/. To learn more , please visit our website - www.maxisit.com/ctos/. Clinical Trial Supply New England . Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs. https://www.almacgroup.com. http://citlabels.com/. She is a career FDA federal service veteran with vast experience in technical and managerial positions across multiple commodities. View Event. Going the last millimeter: What you may not know about home visits. 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. Agilex Biolabs is the leading Australian Bioanalytical CRO providing regulated Bioanalysis to support clinical trials. WORKSHOP: Identifying and overcoming the hurdles associated with global studies including longer timelines, drawn-out budgets and remote teams. It is a 2 day event organised by Arena International Events Group and will conclude on 24-May-2023. Why expert partners and staff matter; what metrics dont tell. 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. Were doing more than streamlining your processes. To learn more , please visit our website - http://www.pcmtrials.com/. 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. Hear from the trial industry as they discuss the services they would like to see from their solution providers, including: Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. This conference is always a great opportunity to share and learn with our colleagues across the industry. http://catalystcr.com/. https://www.anjusoftware.com/, To learn more , please visit our website - The elluminate Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. 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. Our Australian phase I facilities are in Melbourne and Brisbane, and our US phase I facility is located in Minneapolis. March 1 - March 2,2023 Outsourcing in Clinical Trials West Coast. Additionally, Funwie collaborates with colleagues to co-create educational resources as a part of the core team of the Advancing Inclusive Research Site Alliance, which focuses on addressing disparities in clinical research. actalentservices.com, To learn more , please visit our website - ProTrials works with sponsors in the pharmaceutical, biotechnology and medical device industries to deliver high-quality clinical development services in a wide range of therapeutic areas. Clincierge reduces barriers to trial participation by employing patient-centric strategies to enhance the patient experience, increase patient retention, and improve clinical trial performance. www.ACMGlobalLab.com. Kumar earned his Ph.D. from the University of Vermont and was a post-doctoral fellow at the University of Virginia. Operating in 49 countries across the globe, KPS Life is committed to working together with its clients through a hands-on operating model rooted in a partnership approach. Dublin, March 01, 2023 (GLOBE NEWSWIRE) -- The "Clinical Trials Outsourcing Market Share, Size, Trends, Industry Analysis Report, By End-Use, By Therapeutics Area, By Workflow, By Region, Segment . 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. From 1990 to 2008 he held various Clinical Operations positions at Abgenix, Pharmacyclics, Quintiles, Covance and Syntex. To learn more , please visit our website - Our intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable hundreds of sponsors and CROs (including all Top 20 pharma) to extend the reach of drug development, expand patient opportunities and improve data quality helping them bring life-changing therapies to our families and communities around the world. In this presentation we will discuss the following: Clinical development has shifted from a scientifically driven journey to a patient-focused one. https://www.slope.io/. For more information, visit http://www.saama.com. She is acknowledged for her expertise and passion in Data Integrity and Vendor Oversight, and has been recognized as a thought leader in process optimization and standardization as they relate to Inspection Readiness. Our mission is to eliminate the barriers to clinical trials by bringing access to people where they live, work and are willing to engage. FDAs role in maintaining a secure and resilient supply chain. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. vial.com. 2022 edition of Outsourcing in Clinical Trials & Clinical Trial Supply East Asia Conference will be held at InterContinental Seoul Coex, Seoul starting on 29th November. TrialMaster, IRMS MAX, and TA Scan, the companys flagship products, lead the way in reducing complexities in the drug and device discovery and commercialization process. Our Sponsor Edition includes dedicated applications for clinical study planning and budgeting, outsourcing and forecasting. PANEL DISCUSSION: Optimizing oversight & governance: What does oversight mean to you? 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. http://www.endpointclinical.com/. 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. Esther Marfo, is a Project Leader within the Health Equity and Population Sciences department at Genentech. 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. The groundbreaking WATCH-PD study exemplifies how high-dimensional data sources allowing more precise, objective, and higher frequency patient monitoring enable digital biomarker development. Electronic clinical outcome assessments (eCOA)and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. What should we be doing now to anticipate, prepare, prevent and respond? 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. ClinChoice is a leading full-service clinical CRO offering high-quality solutions to pharmaceutical, biotechnology, medical device and consumer products clients. 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. His goal is to help you accelerate your clinical research career and be a more effective leader. 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. www.emmes.com, Emvenio Research is a leading decentralized research organization (DRO) providing scalable and hybrid decentralized trial solutions improving clinical trial access to underserved and high-risk populations. Isabel Brown (she/her) currently works on the Inclusive Research and Health Equity team for Genentech's Research and Early Development, Clinical Operations group. March. 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. In his role as BD lead, he is responsible for many aspects of the companys planning and operations. Passionate about novel tech-enabled medical devices that advance the understanding and treatment of diseases. ), pharmacovigilance and safety solutions, translation and language services, and call center support. Meraf Eyassu is a Executive Director of Clinical Operations at Terns Pharmaceuticals. Frances has an undergraduate degree in Physiology and a PhD in medical science from the University of Sydney. Datacubed Health is a pioneering technology company making better science and healthier communities a reality. 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. Care Access is a global research site that accelerates the availability of new treatments and therapies through our unique site infrastructure and ability to cultivate research-empowered communities. He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning. 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. A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers. www.td2inc.com. 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. Examining the behaviors of clinical trial stakeholders to better understand challenges in patient participation. http://www.medpace.com/. Taking a Data Science approach to gain financial oversight of clinical trials. His father was a physician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. Services are available in U.S., Canada and ROW. In that role, she built and led the commercial organization that developed go-to-market strategies for Potrero's Accuryn Monitoring System. We are focused on helping our clients to address their most significant and complex drug discovery and development challenges. 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 became the Deputy Program Director for OMDRHO in 2017 and ultimately became OMDRHO Program Director in February 2022. www.signanthealth. These conferences closely focus on the advancements in clinical research and trials. http://www.celerion.com. 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. 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. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services. Mr. Luciano earned a B.A. Learn more at www.iqvia.com. 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 . We have expanded our product line to include Medical Device Labeling through AWT Labels & Packaging. Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORAs Office of Import Operations. Mobile in Clinical Trials is the first conference, founded in 2013 to convene R&D operations and digital leaders to get the best access, deploy and scale strategies for applying mobile/digital tools to connect and empower patients, and obtain better outcomes in drug development/clinical research. He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. Local vendor oversight vs global provider oversight how would you manage this differently? For more information, please contact us at 262-334-6020, or via email at Daniel.Selness@spauldingclinical.com. They have fewer surprises, faster outcomes, and stronger data integrity. Deep 6 eliminates months of manual data validation, to de-risk and accelerate clinical trials, because clinical trials should be a gatekeeper (accelerator), not a bottleneck to innovation. The global clinical trials outsourcing market size is expected to reach USD 67.62 billion by 2030, according to a new study. This experience includes in vivo viral- vectored gene therapies, ex-vivo viral vectored and gene edited treatments for oncology and non-oncology patient communities, and RNA medicine modalities. After 3 years as a patent lawyer at Apple Computer, he took a VP role at startup FormFactor, staying in an IP role, then became the first General Counsel for startup Verisity Design, taking them public in 2001, then ultimately through successful acquisition in 2005. Many biopharmaceutical trial sponsors rely on or scientific leaders to help design and optimize their protocols and statistical analysis plans. A significant portion of the cost in a clinical trial can be attributed to operational conduct of the trial such as site monitoring related activities, data management and site oversight. Add the event to your calendar. Outsourcing In Clinical Trials East Coast 2022 User Dashboard. Fusion eClinical Suite is the most adaptable, unified platform that serves as the Connected Hub for all your Clinical Trial and operational data and reporting. He has been actively involved on both sides of the business in managing CDMOs and CROs. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve live. 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. To learn more , please visit our website - Online event and networking. The conference will bring together pharmaceutical and biotech experts to connect and explore solutions to current challenges associated with clinical trials. The 2022 program boasts two full streams including: At UCSF he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. To learn more , please visit our website - http://www.premier-research.com/. Philips BioTel Research is an industry leader in medical imaging and cardiovascular safety testing for clinical trials. Effective management of essential clinical trial documents using eTMF solutions. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. Login; Register now; Toggle navigation. Our Ergomed team is looking forward to exhibiting at Outsourcing Clinical Trials - Texas 2022, December 7th & 8th . To learn more , please visit our website - Arena International are delighted to announceOutsourcing in Clinical Trials West Coastwill be returning to Burlingame for the annual event onMarch 1st& 2nd2023! Be sure to stop by to visit my colleagues at booth #60. February 28, 2023. . 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. 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. After years of watching the opioid crisis develop, John has developed an innovative drug and dispenser to safely treat pain and deter abuse. 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. What can we do to take advantage of high prevalence of disease in populous countries but systems are either rudimentary or non-existent? eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. Parexel Recognized by Frost & Sullivan with 2022 Global Customer Value Leadership Award . Frontageis a CRO providing integrated, scientifically-driven research, analytical and product development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals. 200+. We provide one of the broadest testing portfolios in the industry and this includes Safety & Efficacy testing, Biomarkers & Flow Cytometry, Cell based assays, Oncology/Pathology, Genomics, Virology, Immunology, Microbiology, Bioanalytical Services, early clinical development service and clinical trials supply. www.assistek.com, To learn more , please visit our website - . Join us in April 2023 to learn from the best in the drug development industry and have an opportunity to learn from their experiences. April 28-29, 2016 Dubai, UAE. https://www.nucleusnetwork.com/au/, To learn more , please visit our website - TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. 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. 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). https://www.calyx.ai, 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. To learn more , please visit our website - in Electrical Engineering & Computer Science from UC Berkeley and Ph.D. in Biological & Medical Informatics from UCSF. Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Featuring solutions for automated referrals, eConsent, patient engagement, connected devices, eCOA, and eSource, ClinOne makes participating in a clinical trial a little easier, every day. 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. What is critical to get right to make a digital QM System work? September 28-29, 2022. Dr. Apfel is a California licensed physician with 20+ years of clinical experience in anesthesiology, critical care medicine, and emergency medicine. Medocitys platform is the only solution that provides a fully interactive clinical trial ecosystem enabling early decision making and safety monitoring in real time. To learn more , please visit our website - She has 20+ years of diverse global experience in the biotechnology industry including roles within Clinical Development, Medical Affairs, and Risk Management. 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. May 3 - May 4 @ Barcelona, Spain. Clinical Trials Innovation Programme 2023 is the only platform to . Over the course of his career, he has worked on clinical development of 23 compounds currently marketed in 1 or more therapeutic indications. 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. https://www.worldwide.com, To learn more , please visit our website - Dan Solisfrom TheFDAwill give the closing keynote. Our Leukopaks are available for Research Use Only and Clinical Grade (FDA 21 CFR 1271-compliant) applications. Meghan serves as the VP, Clinical Trial Financial Management at Medidata driving roadmap and strategy across our Grants Manager and Site Payments products. To learn more , please visit our website - She develops strategies to drive greater inclusion of racial and ethnically representative patient populations in clinical research and to advance health equity Gaining patient, clinician and community insights early in program development is integral to developing what is important to patients and improving access to medicines and treatments for all patients, regardless of race, ethnicity, sexual orientation, gender identity, age, socioeconomic status and ability/disability. Why drugs fail in clinical trials? The main program of the conference is discussion and debate on the outsourcing of clinical research. She is currently Director of Patient Safety Medical Device for AstraZeneca and supports products across the enterprise. Visit our website to learn more about how we deliver a Better Clinical Experience. Meraf has over 20 years experience working in biotech, health and the pharmaceutical industry. Prior to this position he was the Division Director for the Division of West Coast Imports since February 9, 2018. Before joining Curebase, Wayne served as Vice President at mid-sized Florida based CRO Biorasi, where he helped to lead that company to a successful acquisition by a private equity partner in 2018.