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. 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. Project Leader, Health Equity And Population Sciences, Hoffman La Roche. Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 3rd-4th May 2023! Topics include feasibility & site selection, clinical data & technology, patient engagement & enrollment, risk-based monitoring, and budeting & clinical outsourcing. The award-winning platform gives unprecedented real-time visibility into clinical data, enabling sponsors to file New Drug Applications (NDAs) more efficiently to bring drugs to market faster and at lower costs. Local vendor oversight vs global provider oversight how would you manage this differently? Extensive Outsourcing and Contracts experience in the area of Clinical Development primarily at small to mid-size biotech organizations. Our specialized experts drive scale, innovation, and speed to market for visionary clients around the world. www.maxisit.com/ctos/. What things do they need a partner to do and what they dont need! Pro-ficiency ensures that everyone in your study is compliant with all training requirements. CROMSOURCE is an international contract research organization providing a comprehensive services to the pharmaceutical and biotechnology companies. He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. EVENT - DIA Global Pharmacovigilance and Risk Management Strategies Conference. 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. 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. What can small biotech ClinOps teams learn from large Pharma, and vice versa? To learn more , please visit our website - SDC delivers top-tier clinical trial services to pharmaceutical, biologic and device/diagnostic companies. 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. Elon Musk's Neuralink sought FDA permission in early 2022 for human clinical trials of its brain-computer interface and received an application rejection, Reuters reports. 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. Outsourcing In Clinical Trials - Texas 2022 - Ergomed PLC 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. 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. Worldwide is changing how the world experiences CROs in the best possible way. To learn more , please visit our website - Explore online site training as a less time/labour intensive way to educate site. His clinical trial experience spans from set-up to delivery across all phases in a wide variety of disease and therapeutic areas. IRT Interactive Response Technologies - Informa Connect 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. 8th Edition of Global Conference on Pharmaceutics and Novel Drug Delivery Systems (PHARMA 2023) Mon, 13 . ACM Global Laboratories is one of the largest global independent central labs in the industry. www.td2inc.com. Novotech is an Australia based clinical CRO operating across Asia and South Africa. Explore and learn more about Conference Series : World's leading Event Organizer. Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible. For over 35 years Parexel has been a trusted global clinical research organization (CRO) and biopharmaceutical services company. THREAD provides key platform features such as eConsent, eCOA/ePRO, sensors, reminders, and telehealth Virtual Visits to support remote data capture, hybrid virtual studies, and fully decentralized studies in key therapeutic areas. Global Player in eClinical Solutions . Dr Frances Rubenstein has worked in clinical data management for more than 20 years in both medical device and pharmaceutical companies. Meraf has over 20 years experience working in biotech, health and the pharmaceutical industry. THREADs platform and supporting services are helping customers to shorten study launch timelines, reduce study budgets with Virtual Visits, and bring studies from the clinic to patients homes. Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. Francis has lead supplier oversight responsibilities for sponsors, CROs and clinical system vendors. News and Events - Ergomed PLC To learn more , please visit our website - http://www.heartcorsolutions.com. TD2 offers fully integrated precision oncology clinical development solutions that combine the highest standards in clinical trials management, disruptive imaging, biomarker strategies, and unparalleled access to real-time patient data. She is a Nurse Practitioner by training and spent over 10 years caring for patients before coming to industry. Swiss Biotech Day 24th April 2023 to 25th April 2023 Basel, Switzerland. We go beyond traditional events and offer, The main program of the conference is discussion and debate on the outsourcing of clinical research. Applied Clinical Trials Online Following its virtual success over the COVID lockdowns, we are pleased to forecast the 2022 live edition will attract even more, with a great speaker line up and up to date content. API Services & Chemical Development. 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. Through Inspire you will access a unique blend of data longitudinally across patients health journey to draw insights that accelerate medical progress and improve healthcare. Outsourcing Clinical Trials New England 2022. 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. She has managed and overseen large global clinical trials in various therapeutic areas and multiple phases of development. To learn more , please visit our website - What can we do to take advantage of high prevalence of disease in populous countries but systems are either rudimentary or non-existent? https://www.nucleusnetwork.com/au/, To learn more , please visit our website - To learn more , please visit our website - TICKETED. WORKSHOP: Identifying and overcoming the hurdles associated with global studies including longer timelines, drawn-out budgets and remote teams. He investigated mechanisms by which active ingredients in cumin seeds halt Prostate Cancer progression and metastasis at the Vattikutti Urology Institute, Henry Ford Hospital. 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). Kris OBrien is an Executive Director in Program Strategy, specializing in Rare Disease and Pediatrics, at Premier Research. www.advarra.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. Making the patient stories the centre of your study with a focus on feedback, Important topics to address with patients, Best timing and approach to successfully engage patients. The conference will bring together pharmaceutical and biotech experts to connect and explore solutions to current challenges associated with clinical trials. Our latest enhancements include patient genetic and biomarker matching to promote swift site identification and patient enrollment. Clinical Research Conferences | Meetings | Events | Symposiums March. Tickets. 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 - 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. https://www.threadresearch.com/, To learn more , please visit our website - It was through this privileged relationship with patients facing devastating diagnoses that Meghan witnessed first hand the life-saving and life-enhancing effects of medical and therapeutic intervention thus piquing her interest in the drug development process. Explore Modern RTSM Solutions. GlobalPlus Diagnostics on LinkedIn: Outsourcing in Clinical Trials Currently, Arvinder is VP of Clinical Development at Rani Therapeutics, where she is responsible for Clinical and Regulatory functions for all programs. 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. Where do the opportunities lie for further acceleration in clinical development? Ndidi Rickert is an experienced Quality Assurance leader with over 20 years of experience in the Pharmaceutical/Biotechnology industry. The elluminate Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources. 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. Flex Databases platform is a secure, unified and compliant system for clinical trials. Our innovative model brings a global network of sites, decentralized trials, Sites On Demand, Virtual PIs, and Mobile Sites to previously-unreachable patient populations to expand the impact of clinical research. 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. Why having IRT experts involved in your study is important. https://www.propharmagroup.com/. ARENSIA is trusted by Leading Pharmaceutical and Biotechnology organizations worldwide. In that role, she built and led the commercial organization that developed go-to-market strategies for Potrero's Accuryn Monitoring System. http://www.arensia-em.com/. Were streamlining your research, helping you get to your next milestone faster. Advarra advances the way clinical trials is conducted to make them safer, smarter, and faster. News; . Importance of teams meeting face-to-face so that human touch and team cohesion isnt lost, Setting up rules and expectations creating space for communication, Strategies for prioritising work and tracking milestones with remote teams, Assessing the impact on the trial of remote vs in-person working; how to find a happy medium, How to best leverage remote trial management platforms, How to best utilize critical and non-critical data validation plans, What trial management services are best provided by the sponsor vs. CRO, How to best manage SOW/budget throughout the course of the trial. To learn more , please visit our website - Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. Esther Marfo, is a Project Leader within the Health Equity and Population Sciences department at Genentech. http://www.medpace.com/. Greenphire is the industry leader of clinical payment technology, designed to improve the way research professionals work. Advice for the ClinOps team to avoid unnecessary patient visits, how does your protocol affect the site? Subsequently, Arun lead the Gastric-Immuno-Oncology Rare Disease Bispecific-T cell-Engager portfolio at Amgen on various aspects of clinical research operations. 2 nd Clinical Case Reports Conference. Genentech Chief Diversity Office, Patient Inclusion And Health Equity. To learn more , please visit our website - Our biotech recruiters, pharmaceutical recruiters and scientific recruiters provide multiple solutions spanning temporary and permanent placement to clients ranging from venture-backed start-ups to Fortune 500 firms. Outsourcing in Clinical Trials Southeast . Outsourcing in Clinical Trials West Coast 2023 - Arena International 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. 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.