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). Our platform consists of 13 modules that cover every aspect of clinical trials, from project startup to pharmacovigilance. 28 - 29. I am very excited to be attending Clinical Outsourcing Group UK this year in London! To learn more , please visit our website - Panellists will address the advantages of DCT; from taking the trial to the patient to boosting recruitment. Clinical ink is the global life science company that brings data, technology, and patient science together. During her career she has supported Class 1-3 devices through the entire product lifecycle. Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. Alton Sartor completed a combined MD/MBA from Tulane University. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. Digital health technologies and biomarkers in clinical trials requires the highest standards of data collection, transmission, security, quality, and analysis. 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. About Mobile Technologies in Clinical Trials. 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. Exploring new science and a futuristic perspective on AB/AM drug development, Exciting growth of artificial intelligence in medicine, A framework on development of artificial intelligence in medicine, The power of public attention and funding, Business opportunity of artificial intelligence in medicine, What they like to see in an outsourced partner organization, What they would like a partner to know about them / how they work. 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. Jay holds an MBA from Villanova University and a degree in Computer Science and Physics from Gettysburg College. Today she serves as the Chief Strategic Officer for Potrero Medical, a Hayward, California-based predictive health company developing the next generation of medical devices with smart sensors and artificial intelligence. From 1990 to 2008 he held various Clinical Operations positions at Abgenix, Pharmacyclics, Quintiles, Covance and Syntex. Previously she served as Head of Clinical Outsourcing and Analytics for BioMarin Pharmaceuticals, where she was responsible for vendor contractual, relationship and financial management. Debashish has previously managed successful eTMF products at Veeva and Medidata, as well as clinical trial imaging tools at Synarc (now part of Clario). 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. Conference series LLC Ltd Organizes 3000+ Global Events Every Year across . Spaulding Clinical operates a 200-bed Clinical Pharmacology Unit, a Full Service Biometrics Group and Cardiac Core Laboratory. https://www.discoverinternational.com/. AliveCors enterprise platform allows third-party providers to manage their patients and customers heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies. Despite the ongoing disruptions from COVID-19, 2021 saw some major results from clinical trials. vial.com. To learn more , please visit our website - This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. 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. We offer both single modules and a unified solution to maintain all processes you can cover all existing software needs with only one vendor. To learn more , please visit our website - For more than 30 years, Rho has been a trusted partner to leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. dpocentre.com. To learn more , please visit our website - For more information, visitwww.eclinicalsol.com, or contact us atinfo@clinicalsol.com. www.rad-md.net. 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. Attendees. Oversight with less presence how to make this work, Effectively building strong working relationships remotely, Strategies to deliver training and upskill your team, Handling hard discussions with your CRO/partner when you cant meet in person, Optimizing communication channels/effectiveness with your CRO partner and team, Maintaining a positive working relationship prioritizing and building strategies from the outset, Clinical trial timelines are lengthy and on average a Phase 3 trial can take between 1-4 years. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences. To learn more , please visit our website - Aug 05 International Conference on Clinical Trials in Endocrinology (ICCTE) - Montreal, Canada. European Union Clinical Trial Regulation: Strategic Considerations, Hyatt Regency San Francisco Airport Hotel
What is critical to get right to make a digital QM System work? We develop new innovations, drive emerging therapies forward and improve patient lives. www.viroclinics.com. Currently a Medical Director/Patient Safety Physician Digital & Devices at Astrazeneca. Diagnostic Services. Vice President, CMC and Supply Chain, Union Therapeutics, Umar Hayat, Ph.D. is VP of CMC and Supply Chain at Union Therapeutics and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. Join Premier Research at Outsourcing in Clinical Trials Southern California 2022 as it returns for its 9 th annual event. To learn more , please visit our website - Rhonda Mecl recently became the Deputy Program Director after serving as the Program's Operations Staff Director for the previous five years. He is a key member of the leadership team responsible for defining the company's go to market strategy and value proposition across the many segments of the pharmaceuticals and device research industry. www.iqvia.com. Triomics is a technology company offering an enterprise-grade platform for clinical trial sites to automate data collection practices. 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. What should we be doing now to anticipate, prepare, prevent and respond? To learn more , please visit our website - 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. Spaulding Clinical Research is a global CRO providing Phase I IV drug development services to pharmaceutical and biotechnology companies. 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. Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). To learn more , please visit our website - www.pro-ficiency.com. Proven track record of coordinating teams in order to meet tight deadlines, set and communicate expectations, and manage deliverables. http://www.novotech-cro.com/, To learn more , please visit our website - 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. With deep expertise in clinical development and more than 25 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day. Explore and learn more about Conference Series : World's leading Event Organizer. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine. Practiced Neuro-Oncology and General Neurology at the VA and Boston Medical Center. assisTek has been paving the way for integrating technology and data collection in clinical trials for over 25 years. 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. His drive to improve healthcare is based on passion, compassion and hope. The Association of Clinical Research Professionals (ACRP) supports clinical research professionals through membership, training and development, and certification. November 28-30, 2016 San Antonio, USA. www.advarra.com. She became the Deputy Program Director for OMDRHO in 2017 and ultimately became OMDRHO Program Director in February 2022. Learn more atwww.clinone.com. To learn more , please visit our website - Topics: http://www.medpace.com/. 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. It is the go-to solution in over 1,000 sites and 40 countries enabling investigators and sponsors to simply record, review, anonymise and submit assessments to regulatory bodies. Theyre more likely to finish on time and on budget. 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. Going the last millimeter: What you may not know about home visits. www.pro-ficiency.com, To learn more , please visit our website - The company serves over 600 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. This conference is always a great opportunity to share and learn with our colleagues across the industry. It was through this privileged relationship with patients facing devastating diagnoses that Meghan witnessed first hand the life-saving and life-enhancing effects of medical and therapeutic intervention thus piquing her interest in the drug development process. http://strategikonpharma.com, To learn more , please visit our website - Improving communication, relationships and work-life balance with your internal team as well as partners. Datacubed applies innovative solutions for the capture of active and passive data for engagement with patients in in-person, hybrid, or fully virtual clinical studies. Bringing together nearly 700 professionals, TFS delivers tailored clinical research services in more than 40 countries. www.viedoc.com, To learn more , please visit our website - Parexel Recognized by Frost & Sullivan with 2022 Global Customer Value Leadership Award . Viroclinics-DDL, a Cerba Research Company is a leading specialty contract research organization, serving the biopharmaceutical community with a broad range of non-clinical research, clinical diagnostics, assay development, laboratory, and clinical trial logistic services. 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. Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc. La Jolla, CA. She leads the scientific development of digital clinical measures and the modernization of clinical development models under the banner Technology As Methodology. Dr. Hayat is managing partner of Revive Pharm USA. She has an extensive background including several years of experience in field medical as well as over 6 years in medical affairs. https://www.threadresearch.com/, To learn more , please visit our website - Employee turnover continues to impact global market for talent. Interactive Response Technologies (IRT) 2022 brings the clinical community together to discuss cutting-edge updates in technology and dives into strategies to help the clinical industry excel in their trials and data management. To learn more , please visit our website - May 3 - May 4 @ Barcelona, Spain. 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. With the most trusted review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra optimizes research performance, empowers clinical sites, and ensures compliance. Ms. Lea is the Director of Global Patient Engagement and Advocacy for Acceleron, a wholly-owned Subsidiary of Merck. To learn more , please visit our website - November 13-14, 2023 Dubai, UAE. theactigraph.com. She also has worked within the clinical department at several reputable companies like Axogen, Medtronic, Coloplast and CR Bard. To learn more , please visit our website - To learn more , please visit our website - Wed, 25 May 2022, 18:00 WebSite. Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables. Dr. Cunningham came from academic background. atreo.io, To learn more , please visit our website - To learn more , please visit our website - He enjoys connecting like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning. To learn more , please visit our website - We look forward to welcoming you In-Person to Amsterdam for Clinical Trials Europe 2022 to celebrate our 21st birthday. Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. In 2010, he became a Supervisor Consumer Safety Officer (SCSO). 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 CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. ClinOne, a leader in virtual clinical trial management, provides a single platform technology experience to accelerate clinical trial enrollment and remote patient care, compliance and retention. A NEW paradigm of engineering-forward analytics solutions powering digital biomarkers. To learn more , please visit our website - http://www.clinicalink.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. Worldwide is changing how the world experiences CROs in the best possible way. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. Altasciences helping sponsors get better drugs to the people who need them, faster. Stop by to see us at Outsourcing in Clinical Trials New England 2021 conference. Optimizing cell-based Gene Therapy Programs through the continued evolution. Kumar earned his Ph.D. from the University of Vermont and was a post-doctoral fellow at the University of Virginia. https://lifesciences.transperfect.com/, To learn more , please visit our website - Rho, a contract research organization (CRO) located in Chapel Hill, NC, provides a full range of services across the entire drug development process. His expertise is in regulated content management, and he is a member of the TMF Reference Model Project Team. From 7 to 9 November 2022. His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today. Advance Research Associates is a premier provider of biostatistical and data management services to the pharmaceutical, biotech, and medical device industries. The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps. An opportunity at Gilead Sciences sparked her move to the West Coast, and she is now settled in the San Francisco Bay Area. The DIA's Digital Technology in Clinical Trials Conference discovers how digital technology is transforming the drug, device, and diagnostics development process in clinical trials. Francis is an expert in clinical system regulatory compliance with over 20 years pharma experience spanning R&D, manufacturing and clinical research. North Carolina, Raleigh-Durham 4 - 5 Apr 2023 . He started his career with FDA in 1998. February 27, 2023. 2023 edition of Outsourcing in Clinical Trials East Coast will be held at King of Prussia starting on 23rd May. Examining the behaviors of clinical trial stakeholders to better understand challenges in patient participation. TICKETED. Precision medicine is in our blood, our cells, our genes, and our name. http://www.peachtreebrs.com. http://www.kpslife.com. eClinical & Clinical Data Management Innovation Conference 2022 . Dont miss out; join us in Burlingame on March 1st& 2nd2023! 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. Are you attending Outsourcing in Clinical Trials West 2023 conference? For more information please contact Graig Daley Business Development Manager and Jackson Young Business Development Associate atsales@citlabels.com. She intentionally injects laughter and authenticity into everything she does, and is an advocate for kindness, diversity and inclusion, as well as issues impacting women and children. Looking forward to another great conference! 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. ARENSIAs outstanding recruitment performance across numerous disease areas substantially reduces the overall number of sites and countries for any early-phase patient trial. . www.tprausa.com. She serves as an advisor for early phase study teams in developing inclusive clinical trials. Reem holds a PhD in genetics from the Hebrew University of Jerusalem. 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. eCOA is our core focus but not our only service. www.ledgerrun.com/, To learn more , please visit our website - Elon Musk's Neuralink sought FDA permission in early 2022 for human clinical trials of its brain-computer interface and received an application rejection, Reuters reports. Our Leukopaks are available for Research Use Only and Clinical Grade (FDA 21 CFR 1271-compliant) applications. She has worked with Calyx for over 7 years as a key strategic leader and director in IRT solutions and services. 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. To learn more , please visit our website - YPrimescloud-based technology streamlines clinical trial data collection and management. To learn more , please visit our website - GreenLight Clinical is a physician-led, boutique full-service clinical CRO with its own central clinical, bioanalytical, histopathology laboratories in Sydney, Australia. We are focused on helping our clients to address their most significant and complex drug discovery and development challenges. Debashish earned a PhD in Computer Science from the State University of New York at Buffalo, specializing in the application of AI techniques in document analysis. 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. www.prevailinfoworks.com. Axiom Exhibiting at Outsourcing in Clinical Trials Southeast 2022. Home / Events /. All three clinics are strategically co-located within leading medical, research and biotech precincts offering unique access to ancillary services including bioanalytical laboratories, MRI, lumbar punctures, chest X-rays, ophthalmology assessments and others. http://www.premier-research.com/, To learn more , please visit our website - https://www.rad-md.net/, To learn more , please visit our website - 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. Together with our client partners, we are fulfilling our purpose of Advancing medicine, improving lives., To learn more , please visit our website - https://www.nucleusnetwork.com/au/. Prior to working at Genentech, she graduated from the Johns Hopkins Bloomberg School of Public Health with a Master of Bioethics. Were streamlining your research, helping you get to your next milestone faster. To learn more , please visit our website - Precision for Medicine (PFM), the full-service global CRO, is purpose-built to accelerate clinical research and development processes to bring life-changing therapeutics to those who need them most. Why expert partners and staff matter; what metrics dont tell. Dr. Apfel is also the Chair of Life Sciences at the Keiretsu Angel Investment Forum, where he invests in life-science companies that have the potential to positively impact patients with serious conditions. www.td2inc.com. At UCSF he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. Mobile in Clinical Trials is the first conference, founded in 2013 to convene R&D operations and digital leaders to get the best access, deploy and scale strategies for applying mobile/digital tools to connect and empower patients, and obtain better outcomes in drug development/clinical research. Outsourcing In Clinical Trials East Coast 2022 User Dashboard. Tactical clinical operations in digital health studies, First-hand learnings, breakthrough device system, a case study. His goal is to help you accelerate your clinical research career and be a more effective leader. 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. 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. ARENSIA is based with its headquarters in Dsseldorf, Germany, and operates with 400+ talented employees in 7 countries, To learn more , please visit our website - www.signanthealth. EVENT - DIA Global Pharmacovigilance and Risk Management Strategies Conference. The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. www.advanceresearch.com. Conferences. Last year alongside talks from industry leaders Pfizer, Bristol Myers Squibb, [] Conference . http://www.endpointclinical.com/. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience. 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. The Global Clinical Trials Connect 2022 will focus on futuristic advancements in the clinical research industry and clinical trials. To learn more , please visit our website - Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 3rd-4th May 2023! Previously, he has led and worked on data science teams across different functions at Janssen Pharmaceuticals, Johnson & Johnson Medical Device Companies and Roche Pharmaceuticals. View Event. She was an assistant professor at Loyola University Chicago and a practicing vascular surgeon in Shanghai, China. In his role as BD lead, he is responsible for many aspects of the companys planning and operations. 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. Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget . We leverage our proprietary payments platform and workflow automation to help clients improve operational efficiency, reduce costs, mitigate regulatory risks, improve the patient and site experience and produce quantifiable results that improve clinical operations and strategic planning. Prior to her work at Potrero, she was the VP of Business Development at Theranova and led marketing initiatives for C. R. Bard (now owned by Becton Dickinson), in both Shanghai and the U.S. She has also worked as a Board Fellow at the American Red Cross Bay Area, currently serves as a guest lecturer at the University of California, San Francisco and Berkeley, and spent several years in sales and training at Johnson & Johnson. To learn more , please visit our website - She has a unique perspective in leading clinical programs in a dynamic startup environment. https://www.muralhealth.com/.
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