deep6.ai, To learn more , please visit our website - His clinical trial experience spans from set-up to delivery across all phases in a wide variety of disease and therapeutic areas. Combining medical expertise and deep industry knowledge, we develop bespoke solutions to accelerate your innovative treatment development for patients with unmet needs, one trial at a time. 2022 looks to be a bumper year too, so Nature Medicine asks leaders in their field what they think . www.orbisclinical.com. To learn more , please visit our website - To learn more , please visit our website - Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone. August, 2023. Agilex Biolabs is the leading Australian Bioanalytical CRO providing regulated Bioanalysis to support clinical trials. At Strategikon Pharma, we bring a high level of precision and speed to outsourced clinical trial operations through our flagship SaaS platform, Clinical Maestro. 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. To learn more , please visit our website - https://www.threadresearch.com/. For more information please contact Graig Daley Business Development Manager and Jackson Young Business Development Associate atsales@citlabels.com. Dr. Jankicevic is a sought-after speaker, and author of numerous articles in peer-reviewed and trade journals. An Introduction to Simulation-Based Training in Clinical Research: De-Risking your Studies in 3 Steps. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. Communities. AliveCor is a privately-held company headquartered in Mountain View, Calif. Consumer or Personal ECGs are ECG devices available for direct sale to consumers. 3 rd Clinical Pharmacy Conference. www.harborclinical.com/. Outsourcing In Clinical Trials East Coast 2022 User Dashboard. Our mission is to eliminate the barriers to clinical trials by bringing access to people where they live, work and are willing to engage. Solution-oriented professional, with strong problem solving capabilities. Mr. Luciano earned a B.A. http://www.axiommetrics.com/. In 2021, ERT and Bioclinica merged to become Clario creating the broadest endpoint technology platform in the industry and enhancing our scientific expertise. Prior to SDCs inception, Richard served on the Board of Directors of Ora, Inc. (www.oraclinical.com) for over 10 years. Commercial Services. Emvenio Research is transforming how patients and care-givers engage in and experience clinical research, To learn more , please visit our website - Who we are; 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. To learn more , please visit our website - To learn more , please visit our website - 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. The two day programme will take a holistic approach to the latest challenges and innovations in clinical operations, such as, the [] Arvinder received her undergrad in Biophysics and doctorate in Cardiovascular Physiology from University of Manitoba, Canada. 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. 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. atreo.io, To learn more , please visit our website - Jay has also created and managed products for eCTD submission publishing and review, enterprise quality management, document management, computer validation, as well as mobile apps for physicians, sales reps, and music and sports fans. She has authored or co-authored 10 publications and has been an advocate for STEM education throughout her career. For more than 40 years, Emmes has been dedicated to research for a healthier world. 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. https://lnkd.in/gEJj4yXX Please come and visit us at stand 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. This, exclusive event brings together attendees from established pharma, large and small, alongside with biopharmaceutical companies and gives opportunity to dive into the operational challenges and innovations in clinical development found within the UK & Ireland region. Deep 6 eliminates months of manual data validation, to de-risk and accelerate clinical trials, because clinical trials should be a gatekeeper (accelerator), not a bottleneck to innovation. Frontageis a CRO providing integrated, scientifically-driven research, analytical and product development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals. 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. I am very excited to be attending Clinical Outsourcing Group UK this year in London! Esther Marfo, is a Project Leader within the Health Equity and Population Sciences department at Genentech. To learn more , please visit our website - 5 th Clinical Nutrition Conference. 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. Boring clinical trials are better clinical trials. 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. Going the last millimeter: What you may not know about home visits. Data-driven operations and oversight with elluminate. I will be there with my colleague Georgi Govedarov, come visit us at booth Isidora Teodorovi on LinkedIn: I am very excited to be attending Clinical Outsourcing Group UK this year She develops strategies to drive greater inclusion of racial and ethnically representative patient populations in clinical research and to advance health equity Gaining patient, clinician and community insights early in program development is integral to developing what is important to patients and improving access to medicines and treatments for all patients, regardless of race, ethnicity, sexual orientation, gender identity, age, socioeconomic status and ability/disability. 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. http://www.mlm-labs.com. CROMSOURCE is an international contract research organization providing a comprehensive services to the pharmaceutical and biotechnology companies. . Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. 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. dpocentre.com. North Carolina, Raleigh-Durham 4 - 5 Apr 2023 . 28 - 29. SDC delivers top-tier clinical trial services to pharmaceutical, biologic and device/diagnostic companies. They have fewer surprises, faster outcomes, and stronger data integrity. Specifically for Clinical Trials and RWE studies, Medocitys modular and flexible architecture ensures swift configuration and deployment in less than 4 weeks, through a fully interoperable and connected SaaS cloud database. Bruce earned his doctorate in biochemistry from UCLA and completed a postdoctoral fellowship at the University of California Berkeley. 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. https://lifesciences.transperfect.com/, To learn more , please visit our website - Kumar earned his Ph.D. from the University of Vermont and was a post-doctoral fellow at the University of Virginia. We atMyonexadd value to our clients by helping them always be prepared for what is next in their clinical trials. Amsterdam RAI. We have access to a population of over 10.5 million people across all 3 sites, and the ability to offer a multi-site solution in recruiting participants and patients to our clients. He was Senior Director of Clinical Operations at Pharmacyclics from 2012 to 2017 where he was responsible for the development, implementation and maintenance of the Clinical Operations infrastructure, as well as the GCP inspection hosting platform and processes, and regulatory authority marketing approval inspection hosting. 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. Henry earned his B.S. Prior to Medable, Reem worked in the clinical space in both the industry and academia settings after making a transition from basic science research. http://www.medpace.com/. 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. Check out who is attending exhibiting speaking schedule & agenda reviews timing entry ticket fees. 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. His expertise is in regulated content management, and he is a member of the TMF Reference Model Project Team. To learn more , please visit our website - Explore Modern RTSM Solutions. WORKSHOP: Identifying and overcoming the hurdles associated with global studies including longer timelines, drawn-out budgets and remote teams. She is definitely not afraid of being the least popular girl in the room in order to support patient safety! Join Premier Research at Outsourcing in Clinical Trials Southern California 2022 as it returns for its 9 th annual event. Saama Technologies is the advanced clinical data and analytics company, unleashing wisdom from data to deliver better actionable business outcomes for the life sciences industry. Making progress of a complex Interventional device study during covid. TORONTO, March 23, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions . Our high-caliber project management, clinical monitoring, medical safety, data management, biostatistics, regulatory affairs and quality assurance capabilities make us a valued partner. Our intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable hundreds of sponsors and CROs (including all Top 20 pharma) to extend the reach of drug development, expand patient opportunities and improve data quality helping them bring life-changing therapies to our families and communities around the world. Prioritizing patient diversity. Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. We work With HeartTMevery day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. We provide personalized patient logistics management, reimbursement, and convenience services to support clinical trial participants. She has extensive experience in leading data management activities for multiregional clinical trials in all phases and several therapeutic areas. Contact: Amy Apostoleris, aapostoleris@medocity.com, To learn more , please visit our website - Wayne resides in Miami, Florida. Over the course of his career, he has worked on clinical development of 23 compounds currently marketed in 1 or more therapeutic indications. Anju is a portfolio company of Abry Partners serving the worldwide pharmaceutical, biotech and contract research Life Sciences markets. 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. Estela Mata is the President and co-founder of Looms for Lupus, a non-profit organization that provides Lupus, Fibromyalgia and Mental Health Awareness, advocacy, and support to those living with these conditions, their loved ones, and caregivers. To learn more , please visit our website - http://kpslife.com/. How do we move forward from here? http://www.kpslife.com. 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. The DPO Centre isEuropes leading life science experts, providing Data Protection Officer (DPO) and Data Protection Representative (DPR) services. 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. 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. 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. To learn more , please visit our website - Were your solution. Agilex Biolabs operate a fully quality-assured, FDA-inspected laboratory (ISO/IEC17025 and OECD GLP). Panellists will discuss the challenges and tech barriers with DCT. FIRESIDE CHAT: Addressing the growing challenge of staff shortages and site delays to develop a seamless contracting and start-up phase. 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. 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. Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget . At UCSF he co-invented suitable PEGylated lipids to make the very first PEGylated liposomes. Medical Writing and Healthcare Communications Conference. 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. 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. Other companies he has founded or co-founded include: 1) IMTH, a real estate investment trust with properties through the state of California; 2) iPill Dispenser, a medical device that uses a mobile app to control a secure, stand-alone pill dispenser to prevent opioid sharing, diversion, and drug overdoses; and 3) NAOMI systems, a practice management software company that integrates digital X-rays devices in PACS, EMR and RCM billing modules. Prior to TransPerfect, Jay directed teams on moving several enterprise product platforms to the cloud at Medidata and Sparta Systems. 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). Sections. Rated 4.5 by 2 people. Conduct of clinical trials are increasingly becoming expensive. 11 th International Conference on Clinical Trials is scheduled to be held during November 09-10, 2023 at London, UK. Novotech is an Australia based clinical CRO operating across Asia and South Africa. INTERACTIVE SESSION Data matters in health outcomes and equity: Collecting and understanding Social Determinants of Health (SDOH) data in clinical trials and beyond. For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. Project Leader, Health Equity And Population Sciences, Hoffman La Roche. 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. Swiss Biotech Day 24th April 2023 to 25th April 2023 Basel, Switzerland. Ms. Lea is the Director of Global Patient Engagement and Advocacy for Acceleron, a wholly-owned Subsidiary of Merck. We help teams bring order, trust, and predictability to protocol execution and automation. Services are available in U.S., Canada and ROW. www.kardia.com. Partnerships in Clinical Trials Europe editions. Mural Health is a participant management platform that helps manage & streamline the trial experience for patients and caregivers. 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. The Outsourcing in Clinical Trials Texas event aims to be a solution-driven conference that allows Clinical Operations professionals to network with innovative vendors, hear cutting-edge content, and participate in interactive discussions. www.promedica-intl.com. We offer customized solutions to fit the needs of each study, patient and site, making it easier for your patients to stick with it. eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. Why having IRT experts involved in your study is important. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/, To learn more , please visit our website - https://www.medidata.com/. www.td2inc.com. To learn more , please visit our website - Imaging endpoints are often used to support go/no-go decision-making in early phase trials. http://www.dsg-us.com/. 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. 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. Francis has lead supplier oversight responsibilities for sponsors, CROs and clinical system vendors. . MaxisITs clinical data analytics platform is a purpose-fit solution developed to improve clinical trial performance, mitigate risk, and optimize clinical outcomes. An opportunity at Gilead Sciences sparked her move to the West Coast, and she is now settled in the San Francisco Bay Area. Greenphire is the industry leader of clinical payment technology, designed to improve the way research professionals work. PANEL DISCUSSION: Decentralized/Hybrid Trials: Discussing the current challenges and debating best practises for a successful virtual study, Considerations and best practices in direct-to-patient (DTP) / decentralized clinical trials (DCT) lessons learned from past trials, PANEL DISCUSSION: Reversing the Conversation What the clinical trial industry really wants from its service providers, KEYNOTE A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around, A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around. The Global Clinical Trials Connect 2022 will focus on futuristic advancements in the clinical research industry and clinical trials. 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. Our Precision Matching software mines millions of patient records, including unstructured physician notes, to pin-point eligible study patients in real-time. 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. Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence. 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. We have successfully been providing exceptional value to our clients for over 30 years. https://www.parexel.com/, To learn more , please visit our website - Tranquil Clinical Research is an early phase CRO with a fully accredited Hospital Phase I unit. 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. www.eclinicalsol.com. Last year alongside talks from industry leaders Pfizer, Bristol Myers Squibb, [] 85356 Mnchen-Flughafen , Join NAMSA 5-6 April in Munich, Germany for Outsourcing in Clinical Trials: Medical Devices Europe. Pharma/Medical Device/Biotech Delegate - Complimentary Pass Register Now. The Budget Conundrum. Register. 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. Tactical clinical operations in digital health studies, First-hand learnings, breakthrough device system, a case study. Slope makes clinical trials boring by using real-time data to orchestrate operational complexity. As an international key opinion leader in dermatology clinical development, Dr. Jankicevic has served as advisor to multiple companies on their path to global regulatory and commercial success. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine. 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. We integrate clinical operations excellence, laboratory expertise, and advanced data sciences to deliver on the promise of personalized therapy; translating research into real-world results and forever reimaging how to get there. Currently, Arvinder is VP of Clinical Development at Rani Therapeutics, where she is responsible for Clinical and Regulatory functions for all programs. In the life sciences vertical, we help pharmaceutical and medical device companies with clinical trial management, data management, biometrics, medical affairs, regulatory affairs, and quality and compliance initiatives. The two day, in person conference, Outsourcing in Clinical Trials will deliver top-quality content from industry experts covering all aspects of operational . Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). She has executed a variety of clinical trials involving therapeutic areas including autologous breast reconstruction, heart failure, hypertension, arrhythmia management and erectile dysfunction. 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. Arena International are delighted to announceOutsourcing in Clinical Trials West Coastwill be returning to Burlingame for the annual event onMarch 1st& 2nd2023! To learn more , please visit our website - Pro-ficiency ensures that everyone in your study is compliant with all training requirements. Dr. Kumar Gadamasetti is an experienced pharmaceutical and biopharmaceutical executive. Zigzag aims to provide straightforward, reliable and flexible Quality Assurance and auditing services on a local or global basis. 25 people interested. Specializing in clinical development and staffing solutions, we offer a flexible approach to ensure our clients unique needs are supported. 12 years at Parexel. Partnerships in Clinical Trials Europe 2022. Join thought leaders from regulatory agencies, biotech, pharma, patients, and academia to discuss the latest advances, challenges, and forward-thinking . www.precisionformedicine.com. Partnerships in Clinical Trials Europe 2021. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence,Worldwide Clinical Trialsprovides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies. https://www.rad-md.net/, To learn more , please visit our website - The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric, and rare disease. As a supervisor, he had the opportunity to manage an Import Field Operation Team, an FDA team in the Centralized Examination Stations (CES), and the Los Angeles International Mail Facility. 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. Fusion eClinical Suite is the most adaptable, unified platform that serves as the Connected Hub for all your Clinical Trial and operational data and reporting. To learn more , please visit our website - . Please email me if you'd like to set up a meeting to discuss your upcoming clinical trials: Parexel Introduces Expert SeriesNew Medicines, Novel Insights. To learn more , please visit our website - Find out about the events you can meet the Caidya team at and stay updated about the latest conferences and clinical research events.
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