Our standard products and services include patient recruitment, eConsent, ePRO/eCOA, interactive digital support and symptom monitoring with the capability to provide an end to end clinical to commercial solution. 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. Anne came to FDA in 1990 with an undergraduate degree in Biochemistry and a masters degree in Food Science and segued into FDAs laboratory science regulatory operations. What are global biotech executives asking/concerned about when evaluating Phase I study plans? Practiced Neuro-Oncology and General Neurology at the VA and Boston Medical Center. Moving to law, in leading law firms he advised major companies on patent matters. Clinical Trial Supply New England . 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 - https://www.anjusoftware.com/. She is mastering the logistics of dosing and testing clinical trial participants where they live, work, and study. To learn more , please visit our website - 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. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. 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. They have fewer surprises, faster outcomes, and stronger data integrity. He also conducted undergraduate research on osteoporosis progression and has authored several papers, abstracts and a book chapter on protein signal transduction. www.curebase.com, To learn more , please visit our website - 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. Having worked within all major biopharma markets including USA, Japan, China, EU and Australia has enabled him to become a trusted advisor to many customers and help them achieve their clinical drug development objectives. Meghan serves as the VP, Clinical Trial Financial Management at Medidata driving roadmap and strategy across our Grants Manager and Site Payments products. https://www.threadresearch.com/, To learn more , please visit our website - With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/WRS) expertise at our core, our services are scalable via our strategic partnerships to provide full-service clinical trial solutions that are The Right Fit For You. https://www.almacgroup.com. I am very excited to be attending Clinical Outsourcing Group UK this year in London! Panellists will discuss the challenges and tech barriers with DCT. Since 2003, Conversis has supported our life sciences clients to successfully and effectively communicate with patients and medical professionals worldwide. With a dual clinical appointment in Robotic-Surgery at the Institute, Arun focused on post-surgical outcomes of Da-Vinci Robotic Prostatectomy for Hormone Refractory Patients. Advarra advances the way clinical trials is conducted to make them safer, smarter, and faster. Currently, Audrey Funwie works in the Patient Inclusion and Health Equity team of Genentechs Chief Diversity Office. Nucleus Network is Australias largest Phase 1 clinical research organisation and the only Phase 1 specialist globally with phase I facilities in the US and Australia. Join us in April 2023 to learn from the best in the drug development industry and have an opportunity to learn from their experiences. To learn more , please visit our website - https://www.parexel.com/. She also has worked within the clinical department at several reputable companies like Axogen, Medtronic, Coloplast and CR Bard. Dr. Karl McEvoy has over a decade of industry experience in both the vendor and sponsor sides. www.frontagelab.com. To learn more , please visit our website - Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideasinto reality. eurofinscentrallaboratory.com/biopharma-services. We develop new innovations, drive emerging therapies forward and improve patient lives. She has been with Calyx for 17 years as a key strategic leader, with a specific focus on IRT solutions. We will synthesize the scientific practices underpinning good instrument design and COA data collection methods and recommend next steps for addressing data collection challenges. Arun received a Bachelors degree in Biological Sciences from University of California-Riverside, a Masters degree in Biomedical Sciences from Wayne State University and completed Doctoral degree coursework from Michigan State University College of Human Medicine. WCG measurably improves the quality and efficiency of clinical trials, helping biopharmaceutical companies, CROs, and institutions facilitate the development of new treatments and therapies for patients. To learn more , please visit our website - www.Clario.com. Wayne holds an MBA and B.S. 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. Rhonda Mecl recently became the Deputy Program Director after serving as the Program's Operations Staff Director for the previous five years. Outsourcing in Clinical Trials Southeast . RadMD, a Medica Group Company, is your full service imaging core lab solution. Parexel Introduces Expert SeriesNew Medicines, Novel Insights. https://www.trilogywriting.com/. How understanding the person behind the patient can improve engagement, Dr. Chris Apfel is the founder and CEO of SageMedic Corp., an early-stage clinical diagnostics company to assist oncologists in selecting the most effective treatment for their patients. To learn more , please visit our website - The conference will bring together pharmaceutical and biotech experts to connect and explore solutions to current challenges associated with clinical trials. Our customized and scalable solutions improve the quality and execution of clinical trials while mitigating costs and allowing clients to retain strategic control. Prevail InfoWorks improves the probability of clinical trial success by providing stakeholders real-time actionable intelligence to effectively manage endpoints and key deliverables with the Single Interface, its patented cloud-based tool that aggregates, reconciles, analyzes and single-view reports/visualizes all clinical, operational and project accounting data, regardless of the source or format. Artificial intelligence in medicine & clinical trials. Why drugs fail in clinical trials? 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. Project Leader, Health Equity And Population Sciences, Hoffman La Roche. 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. 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. As a service company, our mission is the pursuit of health equity, a focus on diversity and excellence in clinical trial conduct. http://www.conversis.com/, To learn more , please visit our website - Our experienced project managers and global network of linguists are supported by proven processes and cutting-edge technology. Since our establishment in 2004, we have conducted over 700 phase I clinical trials, with 80% of our clients consisting of US based biotech and pharmaceutical companies. 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. My training is in genetics (Ph.D.) and mechanical/biochemical engineering (M.S. www.tranquilclinicalresearch.com. This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. She has over 22 years of experience overseeing GxP quality and compliance for all phases of drug development for biologics and small molecules. Mr. Larwood is the third of his family to be involved in Valley Fever. Precision medicine is in our blood, our cells, our genes, and our name. Are Hybrid trials the more realistic and practical approach compared to full DCT agree or disagree? In that role, she built and led the commercial organization that developed go-to-market strategies for Potrero's Accuryn Monitoring System. clinical trials Conferences 2023/2024/2025 is for the researchers, scientists, scholars, engineers, academic, scientific and university practitioners to present research activities that might want to attend events, meetings, seminars, congresses, workshops, summit, and symposiums. The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. Clincierge reduces barriers to trial participation by employing patient-centric strategies to enhance the patient experience, increase patient retention, and improve clinical trial performance. Executive Director, Program Strategy, Rare Disease and Pediatrics, Premier Research, https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, https://www.linkedin.com/in/ndidi-rickert-she-her-47197371/, https://eurofinscentrallaboratory.com/biopharma-services/, eurofinscentrallaboratory.com/biopharma-services, Hyatt San Francisco Airport, Burlingame, San Francisco, Best practices for engaging the patient community and growing that relationship using real life case studies. To learn more , please visit our website - 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. 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. To learn more , please visit our website - Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials. 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. 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. Her experience in a multitude of therapeutic indications has led to an acute knowledge of study conduct and execution with a keen focus on protocol dynamics. https://www.advancedclinical.com/. Ellen Weiss is the Vice President, In-Home Solutions, Decentralized Clinical Trials at PCM Trials. We have successfully been providing exceptional value to our clients for over 30 years. Dr. Hsu is anesthesiologist and pain management physician, but also a serial entrepreneur. At Trilogy, medical writing is our passion. 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. EVENT - DIA Global Pharmacovigilance and Risk Management Strategies Conference. From 7 to 9 November 2022. WORKSHOP: Identifying and overcoming the hurdles associated with global studies including longer timelines, drawn-out budgets and remote teams. To learn more , please visit our website - http://www.yprime.com/, Curebase leads decentralized clinical research using a sophisticated eClinical software platform that manages all site/patient data capture, along with a fully virtual site that acts much like a traditional site, but with greater flexibility and reach. November 28-30, 2016 San Antonio, USA. Ms. OBrien has been conducting clinical research for more than 35 years and has covered multiple functions during that time. Meraf Eyassu is a Executive Director of Clinical Operations at Terns Pharmaceuticals. Best practices and tools for managing supplier governance and ascertaining who is accountable, Identifying the criteria to determine level of oversight needed for a vendor. Topics include feasibility & site selection, clinical data & technology, patient engagement & enrollment, risk-based monitoring, and budeting & clinical outsourcing. Medables completely modular approach allows pharmaceutical companies and clinical research organizations (CROs) to use only what they want, while scaling capabilities to better suit their unique studies. To learn more , please visit our website - http://www.iconplc.com/. Conduct of clinical trials are increasingly becoming expensive. To learn more , please visit our website - To learn more , please visit our website - www.eclinicalsol.com. Parexel Recognized by Frost & Sullivan with 2022 Global Customer Value Leadership Award . She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. http://strategikonpharma.com, To learn more , please visit our website - Focusing on life sciences, Datacubed offers software and services driven by behavioral science to improve patient retention and compliance, resulting in better data and positive health outcomes. Dr. Lindsay Hughes, Director of eCOA Clinical Science and Consulting at Clario, is a scientist and leader with over 15 years of experience in behavioral and life sciences. https://www.worldwide.com, To learn more , please visit our website - Embedding fit-for-purpose technology solutions enhances access, accelerates enrollment, improves representation, and increases compliance and retention, Strategies for successfully hiring and growing a ClinOps team in this day and age, Discussing how training improvements can increase retention, WFH vs in office: Pros and cons of managing a more remote ClinOps team in the US. 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. In addition, 30% of trial participants drop out of the study, Innovation should strive to maximize the synergy of all three variables: safety, efficacy, and speed. I am the CEO at OrPro Therapeutics, a biotechnology company in San Diego, CA developing biologic drug solutions to unmet needs in serious epithelial diseases including cystic fibrosis. Increasing inclusion in future trials for vulnerable populations with health disparities some success stories, Home visits have evolved since their inception in 2003, Services possible in 2023 an overview of what is possible today, Sourcing the right professionals for visits is essential to success, Addressing the reduced site pool challenge and focussing on sites you know can deliver, Overcoming hurdles with imaging centres with reduced staff when trying to qualify patients in a timely manner. Keeping them can be an even bigger challenge. Weve all had to sit through several pitches from vendor companies telling us what they can do for us, but now its time to reverse the conversation! He brings over 25 years of product management, consulting, and engineering experience across verticals such as life sciences, enterprise software, healthcare, government, entertainment and manufacturing. This Clinical Trials Conference includes a wide range of Keynote presentations, Plenary talks, Symposia, Workshops, Exhibitions, Poster presentations and Career development programs. mediantechnologies.com, Medocity is a leading digital health technology company that has been serving the pharmaceutical and life sciences industry for almost a decade.