Login; Register now; Toggle navigation. Kunal has over 18 years of experience managing and conducting clinical trials. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience. To learn more , please visit our website - Debashish has previously managed successful eTMF products at Veeva and Medidata, as well as clinical trial imaging tools at Synarc (now part of Clario). Our specialized experts drive scale, innovation, and speed to market for visionary clients around the world. Decentralized Clinical Trials 2022 was a really good opportunity to . 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. 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. In 2010 she became the Deputy Director of ORAs Southeast Region, and in 2012 she assumed the responsibilities of Acting Director for the Southeast Region. ), both from Duke University where I was also an undergraduate. To learn more , please visit our website - The 2014 event will focus on how companies from the region can implement effective clinical outsourcing strategies. Our customized and scalable solutions improve the quality and execution of clinical trials while mitigating costs and allowing clients to retain strategic control. He has been actively involved on both sides of the business in managing CDMOs and CROs. CISCRP staff is committed to participating and presentingspeaker, chairperson, moderator, advisor rolesin relevant and engaging educational events within the clinical research industry. Dr. Apfel is a California licensed physician with 20+ years of clinical experience in anesthesiology, critical care medicine, and emergency medicine. To learn more , please visit our website - 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. Intrinseque Health is an EN ISO 13485 certified Global Clinical Supply Chain organisation, building & executing complex Clinical Supply Plans for Ancillary, Medicinal products, Clinical Supplies, Equipment and Services required by Pharmaceutical & Biotech companies and CROs for their Clinical Trials. We have been driving the success of our clients, consultants, and employees in staffing and consulting services since 2004. Meghan started her career as a Masters level psychologist working within a medical care team treating patients with ALS and traumatic brain injury. To learn more , please visit our website - Meet Inspiring Speakers and Experts at our 3000+ Global Events with over 1000+ Conferences, 1000+ Symposiums and 1000+ Workshops on Medical, Pharma, Engineering, Science, Technology and Business. How do you arrange with and clean the large amounts of data generated? Dr. David Anderson is a Senior Scientist at Clinical Ink, where he focuses on the development of digital biomarkers in decentralized and remotely-monitored clinical research. How do we move forward from here? Held annually in Paris and online, this event unites 5,000 attendees and 360 exhibitors centered around innovation, networking, and education. Anju is a portfolio company of Abry Partners serving the worldwide pharmaceutical, biotech and contract research Life Sciences markets. LabConnects unique combination of state-of-the-art technology, world-class laboratories, easy access to emerging markets and extensive specialized testing expertise means the drug development industry can rely on a single provider for all of their central lab needs. In addition to her deep understanding of the unique dynamics of developing novel treatments for rare and complex diseases, Dr. Raymond also leverages her combination of training and experience leading the Gene Therapy Think Tank at Worldwide Clinical Trials. With over 15 years experience in the industry, Esther has predominantly worked in clinical trial management and data management roles across Europe, North America and South Africa. 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. Read more. The therapeutic areas include: Cancer, CV, CNS and infectious diseases. www.saama.com. Strategy/Planning: How do you make the decision to run a DCT; what are the considerations? Our experts are ready to discuss how our solutions can best support your live studies. KPS is a global, innovative, Clinical Outsourcing Provider delivering clinical trial monitoring, management and quality oversight services to pharmaceutical, biotechnology, medical device, and related industries. Our goal each day, every day is to make sure our partners have whatever they need when and where they need it to execute a successful clinical trial, while also minimizing delays, unnecessary costs, and surprises. She holds medical license issued by Serbian Medical Chamber. She is currently Director of Patient Safety Medical Device for AstraZeneca and supports products across the enterprise. Ops components of various FIH studies and global P1-P3 drug development programs and post-marketing studies in Oncology, Hematology-Oncology, Immuno-Oncology, Infectious Diseases, Immunology, Metabolic Diseases, Ophthalmology, and Critical Care conducted in North America, Europe, Africa, Central and South Americas, Asia-Pacific regions including Japan, China, So Korea, and Australia *Lead cross-functional teams and successfully contributed to several INDs, NDAs, FDA, EMEA, TGA, and NMPA regulatory filings and approvals of marketed products within HIV/Virology Therapeutic Area *Mentor, motivate, and develop clinical operations teams and direct reports *Strong, flexible, strategic team leader with extensive change management successes *Track record to develop, problem-solve, and execute creative and innovative process improvements and quality efficiencies within development operations *Motivated and driven to continue contributing to drug development in transformative medicines with a focus on unmet medical needs, CLOSING KEYNOTE: ClinOps team focus: Managing relationships, retention and hiring in the new world. The elluminate Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. Contact us for more information and for a live demo tailored to your use case and needs. December 07-09, 2015 Atlanta, USA. He received M.Sc. Outsourcing Clinical Trials New England 2022. 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. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. 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. 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. The news service . Any Device. An international speaker, Dr. Hughes is responsible for a team of scientific experts who provide guidance and analysis services related to the creation of electronic data collection systems for clinical trials. http://www.protrials.com/. 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. In his role as BD lead, he is responsible for many aspects of the companys planning and operations. Any Disease. 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. Dr. Apfel is an internationally known authority on designing, conducting, and publishing highest quality clinical trials with thousands of patients that have changed medical practice with over 100 peer-reviewed publications. A significant portion of the cost in a clinical trial can be attributed to operational conduct of the trial such as site monitoring related activities, data management and site oversight. IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. To learn more , please visit our website - http://www.rhoworld.com/. Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. She received her MS and PhD in Microbiology from New York University and did a postdoctoral research at Merck Research Laboratories. ARENSIA is trusted by Leading Pharmaceutical and Biotechnology organizations worldwide. Over the past 30 years his focus has been in the areas of drug substance as well as drug product R&D, manufacturing and outsourcing the small molecules as well as biologics. Clinical Technologies. 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. Curebase is also pioneering the Bring Your Own Physician (BYOP) model, allowing patients the comfort to make decisions with support from their trusted physician, To learn more , please visit our website - www.curebase.com. Alton Sartor completed a combined MD/MBA from Tulane University. For more information, please contact us at 262-334-6020, or via email at Daniel.Selness@spauldingclinical.com. Best practices for managing CRO governance for small/start-up companies with limited resources or large companies with competing priorities, Driving success in either unexplored settings or in saturated market settings, Maintaining Chain of Identity/Chain of Custody, Evolving Technologies & Regulatory Guidance documents, Roel of Project Management in helping to drive and streamline cross functional communication, Key considerations for communicating timelines and milestones, Maintaining focus on Quality centric culture, Using machine learning to increase efficiency, Leveraging interoperability to streamline operations. Employee turnover continues to impact global market for talent. To learn more , please visit our website - Clinical Trials 2023. AI-ML, a Hype or Hope. Wed, 25 May 2022, 18:00 WebSite. Global Clinical Trials Connect 2023 2022 London United Kingdom. Over 20 years in clinical research, including patient innovation, feasibility, strategy, patient recruitment, retention, site engagement. 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. 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. Emmes acquired Casimir in March 2022, and the . Minimize site activity- could decentralization and Direct-to-Patient trials be the answer to staff shortages? Altasciences full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, data management and more, all of which can be tailored to specific sponsor requirements. In that role, she built and led the commercial organization that developed go-to-market strategies for Potrero's Accuryn Monitoring System. . 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. 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). She is definitely not afraid of being the least popular girl in the room in order to support patient safety! We are an embedded partner dedicated to the success of your study, offering managed services such as: Data Management, On-Demand Data Analytics, Biostatistics, Clinical Management, eTMF Management and Pharmacovigilance. Compare and contrast the FDA, MHRA and TGA regulatory requirements for Phase I clinical entry. Combining OCT, CTS and Medical Devices events, this is the perfect platform for professionals from . Whether you require ad hoc support or a team to partner with on audit programs, we have the people, the expertise and the experience to provide the assistance you need. Study sponsors and contract research organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. CROMSOURCE operates offices across Europe and North America. Chris has dedicated his 16-year career to the services side of the Phase I clinical drug development industry, including both operational and business development roles. 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. 85356 Mnchen-Flughafen , Join NAMSA 5-6 April in Munich, Germany for Outsourcing in Clinical Trials: Medical Devices Europe. 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. 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. Aug 16 International Conference on Clinical Trials in Cardiovascular Medicine (ICCTCM) - Barcelona, Spain. http://www.medable.com/, To learn more , please visit our website - Meghan joined a CNS-focused start up in RTP and has spent the last 15+ years working in the life science technology industry. The 15th annual conference will provide experts in the life science industry to connect and explore solutions to current operational and outsourcing challenges associated with clinical trials . Enhance site negotiations and pay with ease, with the industrys first Procure-to-Pay solution designed specifically for clinical trials. In this position, she focuses on initiatives for employee development or training and topics to advance health literacy for underserved communities as it relates to clinical trial access. Jay holds an MBA from Villanova University and a degree in Computer Science and Physics from Gettysburg College. 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. They have fewer surprises, faster outcomes, and stronger data integrity. Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables. It offers its clients a global reach through a network of 38 processing laboratories. 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. To learn more , please visit our website - http://www.premier-research.com/. 2 nd Clinical Case Reports Conference. How best to go about educating the patient community? http://www.arensia-em.com/. During her career she has supported Class 1-3 devices through the entire product lifecycle.

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