https://lnkd.in/gEJj4yXX Please come and visit us at stand Moving to law, in leading law firms he advised major companies on patent matters. Driven by a unique combination of deep domain expertise and technical capabilities, our ClinRun application suite rethinks trial administration through active engagement, smart design, and breakthrough technology. In addition to several peer reviewed publications and patents he published two volumes on, Process Chemistry in the Pharmaceutical Industry and currently is working on the third volume entitled, Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry jointly with the bio-process leaders at Pfizer. www.saama.com. As Vice President, Business Development at Curebase, Wayne leverages more than a decade of experience in clinical research across both clinical operations and strategic sales to identify new areas for growth within the company. We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. RadMD, a Medica Group Company, is your full service imaging core lab solution. www.assistek.com, To learn more , please visit our website - He also conducted undergraduate research on osteoporosis progression and has authored several papers, abstracts and a book chapter on protein signal transduction. 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. https://www.medidata.com/, To learn more , please visit our website - Explore Modern RTSM Solutions. Stream B: Clinical Innovation & Technology, A Fireside Chat on. CROMSOURCE is an international contract research organization providing a comprehensive services to the pharmaceutical and biotechnology companies. She has actively participated in departmental preparation for the EU CTR implementation and is one of ICONs SMEs on this topic. The report gives a detailed insight into current market dynamics and . Login; Register now; Toggle navigation. 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. UPCOMING EVENT. Evolve our technology to improve the study experience for patients, site, and sponsors with the move towards more decentralized trial models, Software will be more heavily relied upon to keep patients connected, informed, and engaged, Explore the importance of utilizing user-focused research on software design and implementation of eCOA and eConsent in clinical trials, Define the role of leadership in cultivating a Quality and Compliance culture, Establish key considerations for implementation, Explore best practices for ensuring sustainability, Operational analytics including enrollment, protocol compliance and safety, Risk-based analyses and insights with elluminate RBQM, Operational knowledge for data-driven development with elluminate CTMS, Centralized issue management across roles in operations, data and medical review, Sample tracking, data forecasting and financial performance indicators, See how Curebase can design a flexible site model to address specific study concerns, Learn about the features Curebase can incorporate based on Sponsor needs, Witness how virtual sites can be deployed to collect high-quality patient data in real-world settings, Strategies for global patient recruitment, Supplies management and shipping challenges. Boring clinical trials are better clinical trials. https://www.nucleusnetwork.com/au/, To learn more , please visit our website - Overview. www.prevailinfoworks.com. 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. 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. TORONTO, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions and services focused on small-to-medium life science organizations, will be exhibiting at Outsourcing in Clinical Trials New England 2022, October 12-13 in Boston, MA. Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc. This conference intends to focus on the global health and clinical trials around the world. 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. The Budget Conundrum. She is also a Certified Clinical Research Professional, and a trained journalist. 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. He held senior level positions with Relypsa (acquired by Galenica for 1.52B US$), Anacor (acquired by Pfizer for 5.2B US$) and Transcept Pharmaceuticals (revers merger with Paratek). We offer customizable specimen collection kits, specialty testing capabilities, dedicated project management and trial site support, biostorage, and real-time data management and reporting. Esther Marfo, is a Project Leader within the Health Equity and Population Sciences department at Genentech. The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. Pharma/Medical Device/Biotech Delegate - Complimentary Pass Register Now. Were a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. Karl has collaborated with the world's top 20 pharmaceutical companies and has extensive experience in patient-centered outcomes research, eCOA strategy, and drug development. 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. Agilex Biolabs is the leading Australian Bioanalytical CRO providing regulated Bioanalysis to support clinical trials. 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. To learn more , please visit our website - Altasciencesis a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to preclinical and early phase clinical studies, from lead candidate selection to proof of concept. Alton Sartor completed a combined MD/MBA from Tulane University. Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. http://www.protrials.com/. To learn more , please visit our website - https://www.anjusoftware.com/. 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. A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers. Dont miss out; join us in Burlingame on March 1st& 2nd2023! Parexel Recognized by Frost & Sullivan with 2022 Global Customer Value Leadership Award . David Hadden is the pioneer of AI-driven Virtual Patient Simulation technology. https://www.parexel.com/, To learn more , please visit our website - Optimizing cell-based Gene Therapy Programs through the continued evolution. Advice for the ClinOps team to avoid unnecessary patient visits, how does your protocol affect the site? 2022 looks to be a bumper year too, so Nature Medicine asks leaders in their field what they think . DCT was previously done out of necessity but are we seeing it as a new world order? To learn more , please visit our website - 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. 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. Lin, who has been with the company since October 2016, previously served as the Senior Vice President of Sales and Marketing. www.advanceresearch.com. Home / Events /. 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. We are known for our superior statistical leadership and data management expertise and proud to have supported thousands of studies across a diverse range of diseases. Industrial Pharmacy Conference. The two day programme will take a holistic approach to the latest challenges and innovations in clinical operations, such as, the [] actalentservices.com, To learn more , please visit our website - 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. We provide one of the broadest testing portfolios in the industry and this includes Safety & Efficacy testing, Biomarkers & Flow Cytometry, Cell based assays, Oncology/Pathology, Genomics, Virology, Immunology, Microbiology, Bioanalytical Services, early clinical development service and clinical trials supply. In that role, she built and led the commercial organization that developed go-to-market strategies for Potrero's Accuryn Monitoring System. A visual cognitive neuroscientist by training, Dr. Anderson has over a decade of experience developing both hardware and software to evaluate behavioral and neural mechanisms of attention, working memory, and visual perception. Drivers of failures, Flawed clinical study design leading to failures, Diagnostic indicators and early Go/No-Go decisions in proceeding further during clinical study phases. I went into industry for post-doctoral studies at the biotechnology research center at Ciba-Geigy Corp. (Novartis) and have over three decades of academic and industrial research and senior management experience in protein and metabolic engineering, bio-based manufacturing, and drug discovery / development. August, 2023. November 13-14, 2023 Dubai, UAE. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. www.iqvia.com. 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. To learn more , please visit our website - Arun Sivanandam has more than 12 years of experience in clinical research at site and sponsor side. Recognising how Social Determinants of Health contribute to outcomes in disease, Assessing which communities you arent successfully recruiting from and exploring data to understand why, Focussing on education in this space and what we can all do moving forward. The Technology track will seeKimberley Ferguson(Commercial Head of Personalized Healthcare Partnerships, Genentech) discussing all thingsWearables. 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 focused on helping our clients to address their most significant and complex drug discovery and development challenges. http://www.medpace.com/. To learn more , please visit our website - 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. 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. Examining the behaviors of clinical trial stakeholders to better understand challenges in patient participation. http://www.clindatrix.com/. He is a member of DIA, ARVO and CDISC. 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. To learn more , please visit our website - After years of watching the opioid crisis develop, John has developed an innovative drug and dispenser to safely treat pain and deter abuse. An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps. Emmes acquired Casimir in March 2022, and the . The Decentralized Clinical Trials hybrid event, April 18th - 20th in Boston, will provide leading insights and practical guidance on how to decentralize your clinical trials for greater diversity, accessibility and efficiency, with guidance a world-class speaker line up. Clinical Technologies. Can you share some of your workflow procedures? https://www.almacgroup.com. Amsterdam RAI. www.viedoc.com. Q2 Solutions is a leading global clinical trials laboratory services organization that helps biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever. Outsourcing In Clinical Trials East Coast 2022. Eurofins BioPharma Services, Laboratory Testing is a group of Eurofins companies with dedicated testing facilities for global Central Laboratory Services, Bioanalytical Services, and Specialty Virology and Oncology Services. About Mobile Technologies in Clinical Trials. Learn more at www.iqvia.com. Were streamlining your research, helping you get to your next milestone faster. By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. . Any Disease. Wednesday, 28th Sep 2022 - Thursday, 29th Sep 2022 . Dr. Cunningham came from academic background. The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients. 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. www.gobio.com/clinical-research/. Her passion for ensuring that clinical trials are reflective of our society drove her to her most recent work in Health Equity, where she works with a group of committed and passionate individuals to successfully develop and implement scalable and sustainable strategic interventions for the recruitment of underrepresented patient populations. KardiaMobile 6L provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Supraventricular Ectopy, Sinus Rhythm with Premature Ventricular Contractions, Sinus Rhythm with Wide QRS, and Normal Sinus Rhythm in an ECG. Arena International are delighted to announceOutsourcing in Clinical Trials West Coastwill be returning to Burlingame for the annual event onMarch 1st& 2nd2023! Enhance site negotiations and pay with ease, with the industrys first Procure-to-Pay solution designed specifically for clinical trials. Communities. This is a great opportunity to network and share knowledge with regions leading pharmaceutical firms, biotechs and med device companies, discuss operationally efficient, specifically targeted clinical trials. Translational Drug Development (TD2) is a world-class oncology drug development organization specializing in the development of new oncology medicines. To learn more , please visit our website - Add the event to your calendar. http://www.heartcorsolutions.com. Signant Health provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. Scout Clinical, part of the Meeting Protocol Family, provides stress-free, confidential and personalized travel, expense and compensation management services to clinical trial participants on a global scale. www.emmes.com, Emvenio Research is a leading decentralized research organization (DRO) providing scalable and hybrid decentralized trial solutions improving clinical trial access to underserved and high-risk populations. For more information, visitwww.eclinicalsol.com, or contact us atinfo@clinicalsol.com. 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. Francis is an expert in clinical system regulatory compliance with over 20 years pharma experience spanning R&D, manufacturing and clinical research. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018. Diagnostic Services. AWT Healthcare manufacturers clinical trial labels. Her background in Biotechnology and proficiency in Data Management solidified her proven ability to identify data integrity risks, and problem solve the most complaint path to drug submissions and approvals. Who we are; Executive Director, Clinical Outsourcing and Alliance Management, BridgeBio Pharma, Inc. VP Digital Transformation Strategy, Medable, Sr. Director, Clinical Operations NGM Bio, Vice President, Drug Development, Alto Neuroscience, VP Clinical Trial Financial Management, Medidata, Product Director, Decentralised Trial Technology at YPrime, Health Technology - Clinical Research, Meta, Director, eCOA Science & Consulting, Clario, Associate Director, Quality Culture Excellence, Ultragenyx Pharmaceutical, Solutions Consultant, eClinical Solutions, Associate Director of Clinical Operations, CymaBay Therapeutics, Associate Director, Global Regulatory Clinical Services, Global Outsourcing Director, Development Operations, Ascendis Pharma, Sr. Clinical Operations Professional, Imago BioSciences, Senior Director Of Clinical Affairs , Materna Medical, RN, MSN, CCRC, CCRA, Senior Manager of Clinical Affairs and Field Operations Ancora Heart, Deputy Program Director, Office of Medical Devices and Radiological Health Operations (OMDRHO), ORA, FDA, Director, Global Clinical Shared Services at Stryker Neurovascular, Vice President Of Clinical Affairs, Endogenex, Director, Clinical Programs, Clinical Affairs, ReCor Medical, Director, Database Management, Nevro Corporation, Director Global Patient Safety- Device And Digital Health, AstraZeneca, Medical Director, Patient Safety Physician Digital & Devices, AstraZeneca, VP Quality Assurance, Regulatory Affairs And Clinical, IceCure Medical, Vice President, Product Management, Anju Software. With her unique blend of business acumen and technical expertise, Rebecca Lin is a dynamic leader with many years of success in the healthcare industry. Last year alongside talks from industry leaders Pfizer, Bristol Myers Squibb, [] Strategy/Planning: How do you make the decision to run a DCT; what are the considerations? Currently, Arvinder is VP of Clinical Development at Rani Therapeutics, where she is responsible for Clinical and Regulatory functions for all programs. Current topics in the Medical Device Regulatory Landscape, Presented by the FDA. http://www.labconnectllc.com/. We will synthesize the scientific practices underpinning good instrument design and COA data collection methods and recommend next steps for addressing data collection challenges. The main program of the conference is discussion and debate on the outsourcing of clinical research. Contact: Amy Apostoleris, aapostoleris@medocity.com, To learn more , please visit our website - GENENTECH CASE STUDY LGTBQ+ Health Inequities & SOGI collection Why collecting this data is important in your study, Uncovering how Deconstructed Patient Navigation can enhance patient support. Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. Harness the power of video evidence in clinical trials with ChilliPharms compliant platform and suite of video services for filming, de-identifying and reviewing clinical outcome assessments. Pro-ficiency ensures that everyone in your study is compliant with all training requirements. 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. FIRESIDE CHAT: Addressing the growing challenge of staff shortages and site delays to develop a seamless contracting and start-up phase. 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. Europe's leading clinical trials conference focusing on partnerships, outsourcing, operations and technology is now In-person event. Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. 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. Fun fact: Ndidi was born and raised in Sierra Leone, and is a descendant of the Krio people who were freed slaves that returned to Freetown from Africa, America and The West Indies. She is driven by listening and incorporating the patient voice and by finding innovative ways to improve the patient experience. 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. Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence. Combining patient-reported health data, personal medical records, and conversations in the Inspire community uncovers critical insights unattainable with traditional research methodologies. www.frontagelab.com. 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. The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. Clinical Trials conferences 2023 are large-scale multidisciplinary events well attended by clinical researchers, media partners, renowned speakers, sponsors, scientists, exhibitors, and other attendees. http://www.cluepoints.com. 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. 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. vial.com. To learn more , please visit our website - ICACB 2023: Applied Clinical Biostatistics Conference, Rio de Janeiro (Feb 16-17, 2023) ICAHIPHIM 2023: Advanced Healthcare Informatics and Public Health Informatics Management Conference, New York (Feb 16-17, 2023) ICCPP 2023: Clinical Psychiatry and Psychology Conference, Barcelona (Feb 16-17, 2023) ICEPNR 2023: Exercises for Pediatric . Kunal has over 18 years of experience managing and conducting clinical trials. AI-ML, a Hype or Hope. To learn more , please visit our website - He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv. Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. To learn more , please visit our website - Henry is a Vice President of Data Sciences at Medidata. Held annually in Paris and online, this event unites 5,000 attendees and 360 exhibitors centered around innovation, networking, and education. Keeping them can be an even bigger challenge. Previously, Arvinder has worked at CV Therapeutics and Gilead Sciences where she led various projects from early discovery to clinical development. In her spare time, Ndidi enjoys creative writing and interior decorating. At Strategikon Pharma, we bring a high level of precision and speed to outsourced clinical trial operations through our flagship SaaS platform, Clinical Maestro. As a service company, our mission is the pursuit of health equity, a focus on diversity and excellence in clinical trial conduct. Amsterdam RAI. To learn more , please visit our website - She facilitates policy and procedure development within OMDRHO and collaborates with medical product partners in the Office of Medical Product and Tobacco Operations, and with peers throughout CDRH during daily operations and on special projects. Any Where. http://www.medable.com/, To learn more , please visit our website - Our Precision Matching software mines millions of patient records, including unstructured physician notes, to pin-point eligible study patients in real-time.
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