OCT Europe 2022 | SGS - SGSCorp He is also President of SBS Medical Management, a healthcare economic consulting firm for investment banks and Expert Medical Reviews, including the California Medical Board. To learn more , please visit our website - Industrial Pharmacy Conference. Subsequently, Arun lead the Gastric-Immuno-Oncology Rare Disease Bispecific-T cell-Engager portfolio at Amgen on various aspects of clinical research operations. We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. ARENSIAs outstanding recruitment performance across numerous disease areas substantially reduces the overall number of sites and countries for any early-phase patient trial. With presentations and panel discussions on all the hottest industry trends and outsourcing challenges. Complimentary. She holds medical license issued by Serbian Medical Chamber. Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. www.tranquilclinicalresearch.com. 4G Clinical, a leader in randomization and trial supply management (RTSM) for the global life sciences industry, is sponsoring the 2022 Outsourcing Clinical Trials DACH. 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. What can we do to take advantage of high prevalence of disease in populous countries but systems are either rudimentary or non-existent? 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. 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. INTERACTIVE SESSION Data matters in health outcomes and equity: Collecting and understanding Social Determinants of Health (SDOH) data in clinical trials and beyond. Clinical Research Conferences | Meetings | Events | Symposiums She is currently Director of Patient Safety Medical Device for AstraZeneca and supports products across the enterprise. From 2 to 4 November 2021. To learn more , please visit our website - She serves as an advisor for early phase study teams in developing inclusive clinical trials. Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. Dr. Parapiteva is an experienced regulatory professional with over 24 years in the pharmaceutical industry/clinical research organizations. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services. She is a career FDA federal service veteran with vast experience in technical and managerial positions across multiple commodities. http://www.endpointclinical.com/. Dan is responsible for presenting the robust data management solutions made possible with elluminate, and can customize product demonstrations to address specific customer needs. Mr. Larwood is the third of his family to be involved in Valley Fever. 21 - 22. Partnerships in Clinical Trials Europe 2022. . Versiti Clinical Trials Services support biopharma and cell therapy companies through central laboratory, logistics, biomaterials provision, and IRB services. To learn more , please visit our website - DSG, Inc. celebrates over 25 years as a leading global eClinical provider with a fully integrated suite of innovative technology solutions and data management services: Award-winning eCaseLink EDC & DSG Designer for Enterprise licensing with CDISC standards; Risk-Based Monitoring, eSource, IWRS Randomization and Clinical Supply, Drug Safety, Patient Profiles, ePRO, CTMS, Site Payment, Protocol Violations, ad-hoc reporting, CDM services, and digital on-demand Clinical Printing services. She has managed and overseen large global clinical trials in various therapeutic areas and multiple phases of development. RT1 Conducting a study when there is minimal education, Hang Nguyen, Sr. Director, Clinical Affairs, Materna Medical, RT2 Navigating the complex spiderweb of multiple vendor relationships, Sarah Mullen, Vice President of Clinical, HeartFlow, RT3 Training Strategies for a Novel Therapeutic Medical Device, Ann Louise Armstrong, Senior Manager of Clinical Affairs and Field Operations, Ancora Heart, - How the process started and steps taken, - Assessment of eligibility and submission, - Lessons learnt - how it helped and what we did, what we companies can learn and do better, Discussion focusing on Real World Data; an overview of opportunities and challenges in working with RWD/RWE, Ted Chun, Director, Global Clinical Shared Services, Stryker Neurovascular, RT2- Navigating the complex spiderweb of multiple vendor relationships, RT3- Training Strategies for a Novel Therapeutic Medical Device, Ann Louise Armstrong, RN, MSN, CCRC, CCRA, Senior Manager of Clinical Affairs and Field Operations, Ancora Heart. Kris OBrien is an Executive Director in Program Strategy, specializing in Rare Disease and Pediatrics, at Premier Research. She is definitely not afraid of being the least popular girl in the room in order to support patient safety! As an international key opinion leader in dermatology clinical development, Dr. Jankicevic has served as advisor to multiple companies on their path to global regulatory and commercial success. OUTSOURCING IN CLINICAL TRIALS EUROPE 2022 - HealthManagement.org Specializing in clinical development and staffing solutions, we offer a flexible approach to ensure our clients unique needs are supported. Outsourcing in Clinical Trials (OCT) Southern California 2022 Taking place in Boston, 17 - 19 October 2022. Why having IRT experts involved in your study is important. 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. www.versiticlinicaltrials.org, Viedoc designs engaging software for the life science industry. CROMSOURCE operates offices across Europe and North America. 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. 21 October 2022 Outsourcing In Clinical Trials - Texas 2022. Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables. As the Founder and Chairman, he spearheaded the ACS ProSpectives international conferences on, Process Chemistry in the Pharmaceutical Industry, and as the chair, speaker and the moderator at numerous national and international conferences on API Process Chemistry, ADCs and Drug Discovery & Development. A healthy discussion on different disciplines in pre . We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date. 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). This holistic self-service platform provides faster data access and intelligent analytics, empowering clinical trial teams to think innovatively. Learn how elluminate delivers: Empowering excellence in supply through digital quality management systems, In this session our guest speaker will address the challenges with these drugs in development and looking at parallels in a medical device regulatory strategy. Currently, Audrey Funwie works in the Patient Inclusion and Health Equity team of Genentechs Chief Diversity Office. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. We are focused on helping our clients to address their most significant and complex drug discovery and development challenges. Clinical research professional with 25 years of experience in clinical and medical affairs, most recently as Director of Clinical Affairs and Associate Director of Medical Affairs for a global medical device manufacturer focusing on endovascular and surgical repair of aortic disease. KPS Life (www.kpslife.com) is a stand-alone, global functional service provider (FSP) that offers a clinical outsourcing solution across all phases of clinical drug development.