With this expertise, global scale and the broadest endpoint technology platform, Clario will continue to lead the way in clinical trial technology that will transform patients lives. She has over 22 years of experience overseeing GxP quality and compliance for all phases of drug development for biologics and small molecules. 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. Previously, he has led and worked on data science teams across different functions at Janssen Pharmaceuticals, Johnson & Johnson Medical Device Companies and Roche Pharmaceuticals. eClinical & Clinical Data Management Innovation Conference 2022 . Prior to TransPerfect, Jay directed teams on moving several enterprise product platforms to the cloud at Medidata and Sparta Systems. He started his career with FDA in 1998. To learn more , please visit our website - As a service company, our mission is the pursuit of health equity, a focus on diversity and excellence in clinical trial conduct. 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. Founded in 1976, ACRP is a Washington, DC-based non-profit organization with more than 13,000 members who work in clinical research in more than 70 countries. She has been with Calyx for 17 years as a key strategic leader, with a specific focus on IRT solutions. We develop new innovations, drive emerging therapies forward and improve patient lives. This experience has allowed her to understand the nuances that set rare and pediatric studies apart from routine clinical studies and develop proper strategies for clients to execute their studies in real world settings. Chris deep knowledge of the global early phase drug development industry strengthens the tradition of success of Nucleus Network, our customers and partners in Advancing Medicines, Improving Lives. Theyll ensure your translations will be of the highest quality, on time, and within budget. Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. ACM Global Laboratories is one of the largest global independent central labs in the industry. 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. Meraf has over 20 years experience working in biotech, health and the pharmaceutical industry. The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Topics: Partnerships in Clinical Trials Europe 2022 - ntradeshows.com At UCSF he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. Founded in 1985, Promedica International, a woman-owned corporation, is headquartered in Orange County, California. https://www.worldwide.com, To learn more , please visit our website - ClinDatrix, Inc., a CRO, helps pharmaceutical, biotechnology and medical device innovators with clinical projects ranging from Phase I studies to multinational pivotal Phase III trials and post-marketing studies. eCOA is our core focus but not our only service. https://www.discoverinternational.com/. Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. United States, 94010, To learn more , please visit our website - She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. Triomics is a technology company offering an enterprise-grade platform for clinical trial sites to automate data collection practices. 8 th Pharmaceutics and Novel Drug Delivery Systems Conference. http://www.heartcorsolutions.com. The two day, in person conference, Outsourcing in Clinical Trials will deliver top-quality content from industry experts covering all aspects of operational . To learn more , please visit our website - 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. Meghan started her career as a Masters level psychologist working within a medical care team treating patients with ALS and traumatic brain injury. Signant unites eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industrys most comprehensive patient-centric suite an evolution built on more than 20 years of proven clinical research technology. Wednesday, 28th Sep 2022 - Thursday, 29th Sep 2022 . 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. Complimentary. Clinical Trials Innovation Programme 2023 is the only platform to . She is mastering the logistics of dosing and testing clinical trial participants where they live, work, and study. 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. Over the years, Lin has achieved success at both large corporations and startups. Funwie strives to do meaningful work that combines and applies her bioethics background while prioritizing and addressing health equity in the context of clinical studies, patient experience, and policy. Global Clinical Trials Connect 2023 2022 London United Kingdom Industrial Pharmacy Conference. 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. Partnerships in Clinical Trials Europe editions. Finding patients is a challenge. MedPoint Digital develops intuitive, ICH-GCP compliant eClinical platforms for virtual investigator meetings, trial portals, interactive modules, and virtual clinical trials. Henry earned his B.S. Project Leader, Health Equity And Population Sciences, Hoffman La Roche. Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORAs Office of Import Operations. www.frontagelab.com. 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. Previously, Bruce held leadership roles at Alkahest, Celerion and Allon Therapeutics, and works closely with the Michael J Fox Foundation, chairing one of their scientific review panels. 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. To learn more , please visit our website - With presentations and panel discussions on all the hottest industry trends and outsourcing challenges. Our mission is to optimize the Clinical Trial Ecosystem, applying industry experience and the latest technology to streamline, secure, and enhance the interactions between sponsors, sites, CROs, and others involved in administering and operating clinical trials. Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. Currently, Audrey Funwie works in the Patient Inclusion and Health Equity team of Genentechs Chief Diversity Office. www.Clario.com, To learn more , please visit our website - 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. Medical Writing and Healthcare Communications Conference. Pharmapack is the European event focal point for the pharma packaging and drug delivery device industry. 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. At Trilogy, medical writing is our passion. Should our biggest concern post-covid be remote working? Clinical Research Conferences in 2023/2024/2025 - World Academy of There, he employed a broad range of methodologies, including: visual psychophysics, neuropsychological and computer-based cognitive assessments, eye tracking, electrophysiology, and structural imaging. Why the current state of trials makes it difficult for patients to participate in research, How and when to incorporate patient insights into your programs, How to create a business case to garner support for investing in solutions, The benefit for the study sponsor, and other stakeholders, for investing in solutions to make it easier to be a participant, Barriers to patient participation with a focus on the barrier that became the impetus of the model, Delving into benefits of Patient Navigators and challenges with consistent comprehensive support for patients, Exploring the Enhanced Patient Support Services, Cover proactive strategies to address performance risk and protocol deviations, How to apply performance data from simulation-based training to manage risk areas, Discuss how to interpret and apply learning results to optimize and de-risk your DCT, Rethinking your site management strategy to minimize overburdening sites, dependant on the phase of your study, Pinpointing how site turnover impacts the sponsor and how to help reduce it whilst keeping patient care front of mind. PANEL DISCUSSION THE PATIENT IMPACT: Patient recruitment, patient centricity & virtual trials Navigating the New Normal, QUICK FIRE ROUNDS: The Patient Perspective, Keynote Not just ticking a box: Outreach to minority groups is improving but the focus now is on establishing trust and relationships. Peachtree BioResearch Solutions is an Atlanta-based Clinical Research Organization that provides clinical development support services and innovative resourcing solutions to medical device, pharmaceutical, and biotech companies. 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. Currently he is the CEO of Certum Bio in San Francisco Bay area and honors the co-appointment as the Member of the Board of Advisors, UC Berkeley Postdoc Entrepreneurs Program (BPEP). 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. www.rad-md.net. With more than30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients. For more than 30 years, Rho has been a trusted partner to leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. 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. To learn more , please visit our website - Worldwide is changing how the world experiences CROs in the best possible way. I look forward to being in the Bay Area in early Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences #outsourcing Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. April 28-29, 2016 Dubai, UAE. Practiced Neuro-Oncology and General Neurology at the VA and Boston Medical Center. Tactical clinical operations in digital health studies, First-hand learnings, breakthrough device system, a case study. Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. La Jolla, CA. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. To learn more , please visit our website - http://www.clinicalink.com/. To learn more , please visit our website - To learn more , please visit our website - The report gives a detailed insight into current market dynamics and . Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. Cliniacal Trials 2023 | 13th International Conference on Clinical atreo.io, To learn more , please visit our website - ProTrials Research, Inc., is a full-service clinical research organization (CRO) and woman-owned business headquartered in San Jose, CA, with clinical operations personnel located throughout North America and across the world. Panellists will address the advantages of DCT; from taking the trial to the patient to boosting recruitment. The two day programme will take a holistic approach to the latest challenges and innovations in clinical operations, such as, the [] Combining medical expertise and deep industry knowledge, we develop bespoke solutions to accelerate your innovative treatment development for patients with unmet needs, one trial at a time. Prior to her work at Potrero, she was the VP of Business Development at Theranova and led marketing initiatives for C. R. Bard (now owned by Becton Dickinson), in both Shanghai and the U.S. She has also worked as a Board Fellow at the American Red Cross Bay Area, currently serves as a guest lecturer at the University of California, San Francisco and Berkeley, and spent several years in sales and training at Johnson & Johnson. Understanding Social Determinants of Health: Identifying the variables that burden trial participants how can we collect this data? ARENSIAs speed and data quality provide our Partners/Sponsors with a strategic advantage across the entire lifecycle of a project, as they can progress their novel compounds much faster to later phases of research. Any Where. It offers its clients a global reach through a network of 38 processing laboratories. Communities. To learn more , please visit our website - www.gobio.com/clinical-research/. OUTSOURCING IN CLINICAL TRIALS EUROPE 2022 - HealthManagement.org assisTek has been paving the way for integrating technology and data collection in clinical trials for over 25 years. 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. PANEL DISCUSSION: Decentralized/Hybrid Trials: Discussing the current challenges and debating best practises for a successful virtual study, Considerations and best practices in direct-to-patient (DTP) / decentralized clinical trials (DCT) lessons learned from past trials, PANEL DISCUSSION: Reversing the Conversation What the clinical trial industry really wants from its service providers, KEYNOTE A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around, A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around. San Diego Marriott La Jolla. OCT Europe 2022 | SGS - SGSCorp This conference will focus on topics such as bioethics, regulations, patient recruitment, site selection, data integration & strategy, and many more. He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning. Were doing more than streamlining your processes. Partnerships in Clinical Trials Europe 2022. Scalable clinical analytics platforms built within core engineering frameworks are the only way to ensure the integrity, repeatability, and value of data standards and insights. Caroline is experienced in the planning and execution of global clinical drug trials in the European, North American, Latin American, and Asia Pacific regions. Stop by to see us at Outsourcing in Clinical Trials New England 2021 conference. He played a pivotal role in the development and commercialization of Veltassa (USA and EU), a treatment for hyperkalemia, Intermezzo for MOTN insomnia, Kerydin for onychomycosis, and Eucrisa for atopic dermatitis. Heather Kellerman on LinkedIn: Are you attending Outsourcing in AliveCor, Inc. is transforming cardiological care using deep learning. 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. PANEL DISCUSSION: Optimizing oversight & governance: What does oversight mean to you? Visit our website to learn more about how we deliver a Better Clinical Experience. To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com. Prior to joining Iovance she served as the VP of Quality at Immune Design which was acquired by Merck. Vice President, CMC and Supply Chain, Union Therapeutics, Umar Hayat, Ph.D. is VP of CMC and Supply Chain at Union Therapeutics and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. UPCOMING EVENT. Enhance site negotiations and pay with ease, with the industrys first Procure-to-Pay solution designed specifically for clinical trials. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine. Genentechwill give a case study session onpiloting health inequities and gender identity data why collecting this data now will aide you with your clinical trial. Taking a Data Science approach to gain financial oversight of clinical trials. OMDRHO is one of five programs in the Office of Medical Products Operations within FDAs Office of Regulatory Affairs. She currently serves as Vice President of Clinical Affairs at Endogenex, a medical device company developing innovative solutions for the treatment of Type 2 diabetes. Altasciences helping sponsors get better drugs to the people who need them, faster. IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. 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. Medrio is the leading provider of eClinical technology for pharma, biotech, device, diagnostics, and animal health clinical trials. Pro-ficiency ensures that everyone in your study is compliant with all training requirements. To learn more , please visit our website - http://www.premier-research.com/. Advantages of working alongside grass root organisations and PAGs what groups are out there? 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. Saama Technologies is the advanced clinical data and analytics company, unleashing wisdom from data to deliver better actionable business outcomes for the life sciences industry. Outsourcing in Clinical Trials Southern California 2022. To learn more , please visit our website - With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022. 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. Outsourcing in Clinical Trials (OCT) Southern California 2022 http://www.datacubed.com/. Anju is a portfolio company of Abry Partners serving the worldwide pharmaceutical, biotech and contract research Life Sciences markets. 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! Ms. Lea is the Director of Global Patient Engagement and Advocacy for Acceleron, a wholly-owned Subsidiary of Merck. May 3 - May 4 @ Barcelona, Spain. Includes management of the RFP process for outsourced services as well as contract/proposal and budget negotiations, vendor selection, and vendor oversight/relationship management. 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. Taking place in Boston, 17 - 19 October 2022. They have fewer surprises, faster outcomes, and stronger data integrity. Are you planning to attend the upcoming Outsourcing in Clinical Trials New England, November 9-10th, 2021? Online event and networking. The Decentralized Clinical Trials hybrid event, April 18th - 20th in Boston, will provide leading insights and practical guidance on how to decentralize your clinical trials for greater diversity, accessibility and efficiency, with guidance a world-class speaker line up. Our experts are ready to discuss how our solutions can best support your live studies.