I will be there with my colleague Georgi Govedarov, come visit us at booth Isidora Teodorovi on LinkedIn: I am very excited to be attending Clinical Outsourcing Group UK this year He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. www.gobio.com/clinical-research/. For over 35 years Parexel has been a trusted global clinical research organization (CRO) and biopharmaceutical services company. Where do the opportunities lie for further acceleration in clinical development? To learn more , please visit our website - To learn more , please visit our website - . Tickets. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. He also served on multiple FDA Headquarter working group and committee related to Food Safety Modernization Act (FSMA), import process improvement, strategic framework, rapid screening technology, and partnership agreements. Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. I am passionate about the life sciences and the clinical and commercial potential of novel therapeutics and applications of synthetic biology. TORONTO, March 23, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions . 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. 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. 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. Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. She has authored or co-authored 10 publications and has been an advocate for STEM education throughout her career. 21 - 22. Key changes for the implementation of the EU CTR, Preparation for the EU CTR implementation, Submission efficiencies when using a CRO in the EU, Exploring how to introduce a new digital quality compliance management system. eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. Wayne holds an MBA and B.S. What are global biotech executives asking/concerned about when evaluating Phase I study plans? 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. 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. Clinical Trial Supply New England . She has driven program strategy and planning, including implementation of 300+ clinical study protocols in 25+ indications, by leading global cross-functional teams towards successful regulatory submissions, product launches, and innovative lifecycle management. Boring clinical trials are better clinical trials. www.td2inc.com. Parexel Introduces Expert SeriesNew Medicines, Novel Insights. To learn more , please visit our website - 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. https://www.rad-md.net/, To learn more , please visit our website - Partnerships in Clinical Trials Europe 2020. Additionally, our tech-enabled trial management system, streamlined study startup processes, centralized pre-screening call center, and unparalleled approach to patient recruitment will successfully deliver a superior CRO experience. 28 - 29. Were a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. He is a member of DIA, ARVO and CDISC. Electronic clinical outcome assessments (eCOA)and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Kunal has over 18 years of experience managing and conducting clinical trials. The 15th Annual Outsourcing in Clinical Trials New England event will bring together clinical trial professionals from big and small biopharma to uncover new technologies and processes, to optimize their clinical and outsourcing operations. 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. Panellists will address the advantages of DCT; from taking the trial to the patient to boosting recruitment. To learn more , please visit our website - An opportunity at Gilead Sciences sparked her move to the West Coast, and she is now settled in the San Francisco Bay Area. Topics: Richard holds a Ph.D. in Industrial Engineering with a focus on applied statistics, quality, and reliability engineering from Arizona State University (ASU), a Master of Science in Industrial Engineering focused in Operations Research and Production Systems (ASU) and a Bachelor of Science in Engineering in Industrial Engineering (ASU), and is certified as a Six Sigma Black Belt. Learn more about and Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp. The therapeutic areas include: Cancer, CV, CNS and infectious diseases. 200+. www.eclinicalsol.com. 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. Practiced Neuro-Oncology and General Neurology at the VA and Boston Medical Center. Previously, Arvinder has worked at CV Therapeutics and Gilead Sciences where she led various projects from early discovery to clinical development. www.flexdatabases.com. http://www.medable.com/, To learn more , please visit our website - February 28, 2023. . Explore online site training as a less time/labour intensive way to educate site. She has a wealth of knowledge and experience having served more than 24 years in ORA managing staff and operations focused on medical devices, radiological health, and MQSA. Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. 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. Alton Sartor completed a combined MD/MBA from Tulane University. . Kardia is the first AI-enabled platform to aid patients and clinicians in the efficient detection of atrial fibrillation, the most common arrhythmia and one associated with a highly-elevated risk of stroke. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. With an agenda covering the future of Clinical trials, patient centricity, digitalization and drug development post COVID, Clinical Trials Innovation Programme 2023 will feature tailored sessions presented by the leading experts and service providers from across the globe. Examining how, even as a small company with limited resources you can successfully introduce time and cost saving QMS measures. 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. 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 - http://www.celerion.com. Brandi has participated in numerous regulatory inspections as the Management representative, authored HHEs for all levels of products and issues and prides herself on being a patient advocate. He has been a visiting professor at Catholic U., Louvain, Belgium and U. Pittsburgh, Pittsburgh, PA and visiting speaker at Humboldt U. in Berlin, Germany. AliveCor, Inc. is transforming cardiological care using deep learning. The 2023 program boasts 4 full streams jam packed with content: It was very interesting, both the presentations and the meeting opportunities. To learn more , please visit our website - 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. Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 3rd-4th May 2023! Specialized in clinical strategy and projects within digital health, with experience spanning from product ideation to commercialization. ClinChoice is a leading full-service clinical CRO offering high-quality solutions to pharmaceutical, biotechnology, medical device and consumer products clients. Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. Greenphire is the industry leader of clinical payment technology, designed to improve the way research professionals work. OMDRHO is one of five programs in the Office of Medical Products Operations within FDAs Office of Regulatory Affairs. Their experienced research team comprises key opinion leaders, board-certified cardiologists and radiologists, sub-specialty scientists, and highly trained technicians who acquire, evaluate, and report high-quality data through an efficient, cloud-based infrastructure. . Cognizing & mitigating Does AI-ML offer a solution? 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. We contribute to a safer and better world by helping our sponsor clients accelerate drug and device approvals to market. Chemistry degree from Punjab University, Institute of Chemistry, Executive Director, Global Digital Quality Management Systems and Business Intelligence BeiGene, Executive Director, Global Medical Affairs Study Management, BioMarin Pharmaceuticals, Inc. Wendi Carroll received her Pharm D from the University of the Pacific. 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. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. 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. Experienced in research methodologies and conducting qualitative and quantitative research in a variety of therapy areas including respiratory, cardiology, oncology, immunology rare diseases and emerging therapy areas. We are now in the position now to share our practical experiences with Decentralized & Hybrid Clinical Trials; The bedrock of a successful trial is a well-designed protocol with reliable measurements of biomedical and health-related outcomes to satisfy regulatory standards. UPCOMING EVENT. . She became the Deputy Program Director for OMDRHO in 2017 and ultimately became OMDRHO Program Director in February 2022. Quickly upscaling digital technologies. 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. Other companies he has founded or co-founded include: 1) IMTH, a real estate investment trust with properties through the state of California; 2) iPill Dispenser, a medical device that uses a mobile app to control a secure, stand-alone pill dispenser to prevent opioid sharing, diversion, and drug overdoses; and 3) NAOMI systems, a practice management software company that integrates digital X-rays devices in PACS, EMR and RCM billing modules. OCT DACH Conference 2022 - Outsourcing in Clinical Trials. How best to go about educating the patient community? 2022 looks to be a bumper year too, so Nature Medicine asks leaders in their field what they think . To collaborate with CISCRP for your upcoming event, please contact Joan Chambers at jchambers@ciscrp.org or Lindsey Elliott at lelliott . What can we do to take advantage of high prevalence of disease in populous countries but systems are either rudimentary or non-existent? Henry earned his B.S. In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners. To learn more , please visit our website - Panellists will discuss the challenges and tech barriers with DCT. Lead on the diversity and inclusion team, and member of DTRA, CISCRP and other industry consortiums aimed at improving access to clinical research and providing clinical research as a care option. www.saama.com. Specializing in clinical development and staffing solutions, we offer a flexible approach to ensure our clients unique needs are supported. Network with 600+ clinical peers. His current work focuses on deep collaboration with an interdisciplinary team of engineers and scientists to successfully integrate data from multiple assessments and sensors, implement high-dimensional feature engineering, and both evaluate as well as apply scalable machine learning algorithms. Read more. Their services include clinical monitoring, clinical monitoring oversight, clinical trial management, data management, biometrics, and medical writing. 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. For more than 20 years, Axiom has delivered data-driven, powerful and cost-effective eClinical Solutions and Services dedicated to small-to-medium life science companies. 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. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018. 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. He has worked for CROs as well as small and large biotechnology companies. With locations in the US and EU, Catalyst offers highly flexible and customized, customer-centric solutions from Global Resourcing and FSP, to Full Service Managed Solutions, with a focus on oncology product development. CROMSOURCE operates offices across Europe and North America. The groundbreaking WATCH-PD study exemplifies how high-dimensional data sources allowing more precise, objective, and higher frequency patient monitoring enable digital biomarker development. Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience. www.tprausa.com. Arun Sivanandam has more than 12 years of experience in clinical research at site and sponsor side. 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. Dr. Raymond completed her doctoral training in molecular biology at University of California San Diego and post-doctoral training in molecular biology at Memorial Sloan-Kettering in New York City, New York, USA. Exploring the need for a dedicated regulatory pathway for antibacterial/antimicrobial drugs. PANEL DISCUSSION: The concept of DCT, is it the future? https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, To learn more , please visit our website - https://www.medidata.com/. medtech.labcorp.com. vial.com. To learn more , please visit our website - The must attend clinical outsourcing event in the Southeast region where industry professional can encounter a platform to explore new solutions to common issues within their clinical trial. http://www.conversis.com/, To learn more , please visit our website - Actalent is a leading provider of Clinical and Laboratory services. eurofinscentrallaboratory.com/biopharma-services. To learn more , please visit our website - http://www.clinicalink.com/. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022. She is currently Director of Patient Safety Medical Device for AstraZeneca and supports products across the enterprise. Since 2000, Anne has held supervisory and branch director positions. 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). 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.

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