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. 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. Conference . By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience. Were a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. Please email me if you'd like to set up a meeting to discuss your upcoming clinical trials: 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. 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. I look forward to being in the Bay Area in early Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences #outsourcing 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. 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. Weve all had to sit through several pitches from vendor companies telling us what they can do for us, but now its time to reverse the conversation! Featuring solutions for automated referrals, eConsent, patient engagement, connected devices, eCOA, and eSource, ClinOne makes participating in a clinical trial a little easier, every day. We proactively plan, coordinate and write clinical documents to meet timelines, with a readability that reduces the time for review and approval. Outsourcing in Clinical Trials Southern California 2022. To learn more , please visit our website - To learn more , please visit our website - Dr. Richard Abelson, President & CEO of Statistics & Data Corporation (SDC), founded the company in November of 2005. Outsourcing In Clinical Trials East Coast 2022. Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. Mr. Luciano earned a B.A. Nucleus Network is Australias largest Phase 1 clinical research organisation and the only Phase 1 specialist globally with phase I facilities in the US and Australia. Rigorous scientific background and 9+ years of experience in driving both academic and industry clinical programs. November 13-14, 2023 Dubai, UAE. CROMSOURCEis unparalleled in offering an end-to-end guarantee covering trial timelines, enrollment, and price. Scalable, Reliable. Meghan received her Masters Degree in Human Biology at San Francisco State University and her Bachelors Degree in Economics at University of North Carolina, Chapel Hill. European Union Clinical Trial Regulation: Strategic Considerations, Hyatt Regency San Francisco Airport Hotel 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. www.Clario.com, To learn more , please visit our website - 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. https://www.anjusoftware.com/, To learn more , please visit our website - Strategy/Planning: How do you make the decision to run a DCT; what are the considerations? She has held key national leadership roles including advisor within the Obama/Biden administrations global HIV response team, advisor to United Nations leadership and instructor at the CDC and USAID. Improving communication, relationships and work-life balance with your internal team as well as partners. THE 2023 AI UPDATE AI & disruptive technology: Harnessing the future of Artificial Intelligence to transform clinical trials, FIRESIDE CHAT: Overcoming the barriers to trial innovation and technology access from a small companys point of view. 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. In partnership with customers, we build solution-driven teams working for a healthier future. Last year alongside talks from industry leaders Pfizer, Bristol Myers Squibb, [] We provide a comprehensive digital solution for Ph 1-4 studies with enterprise-level capability that is configurable to be fit for purpose to support biopharmaceutical companies, CROs and research sites. Who we are; Parexel Recognized by Frost & Sullivan with 2022 Global Customer Value Leadership Award . Phase 1 Trials: How to globalize to accelerate value inflection. Saamas unified, AI-driven clinical data analytics cloud platform seamlessly integrates, curates, and animates unlimited sources of structured, unstructured, and real-world data to deliver actionable insights across all therapeutic areas. https://www.rad-md.net/, To learn more , please visit our website - Flex Databases platform is a secure, unified and compliant system for clinical trials. Actalent is a leading provider of Clinical and Laboratory services. Arena International are delighted to announce that our Outsourcing Clinical Trials Europe event is returning to an in-person format in 2022. Outsourcing Clinical Trials New England 2022. Find out about the events you can meet the Caidya team at and stay updated about the latest conferences and clinical research events. We go beyond traditional events and offer, The main program of the conference is discussion and debate on the outsourcing of clinical research. 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. Anju is a portfolio company of Abry Partners serving the worldwide pharmaceutical, biotech and contract research Life Sciences markets. Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. https://www.slope.io/. 21 October 2022 Outsourcing In Clinical Trials - Texas 2022. Conduct of clinical trials are increasingly becoming expensive. Since 2000, Anne has held supervisory and branch director positions. The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. 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. To learn more , please visit our website - GxPs in Cell Therapy and key considerations for Quality and Project Management. We offer customized solutions to fit the needs of each study, patient and site, making it easier for your patients to stick with it. The 2023 programme will offer a fresh insight into the latest regulatory updates, global clinical trials, advanced technologies such as digital health and connected devices space, and more. Contact: ESMO Registration Office; Phone: [+41 (0) 91 973 19 13]; Email: registration@esmo.org. Arena International are delighted to announce the Outsourcing in Clinical Trials Southern California Event will be returning to California's La Jolla on September 26th & 27th 2023! The DPO Centre isEuropes leading life science experts, providing Data Protection Officer (DPO) and Data Protection Representative (DPR) services. Signant unites eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industrys most comprehensive patient-centric suite an evolution built on more than 20 years of proven clinical research technology. Pharma/Medical Device/Biotech Delegate - Complimentary Pass Register Now. Read more. Advice for the ClinOps team to avoid unnecessary patient visits, how does your protocol affect the site? In a separate article, Manasi Vaidya discovers that, fuelled by the successful use of mRNA vaccines in Covid-19, RNA therapeutics are expected to make larger strides in 2022.. Based on available data, there are emerging trends . 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. The report gives a detailed insight into current market dynamics and . She is currently the Founder and CEO of Strategikon Pharma, developer ofClinical MaestroTM, the industrys only end-to-end cloud-based platform for clinical trial budgeting, sourcing and budget management including strategic alliance/partnership management. With an agenda covering the future of Clinical trials and drug development post COVID, Clinical Trials Innovation Programme 2023 will feature tailored sessions presented by the leading experts from across the . The global clinical trials outsourcing market size is expected to reach USD 67.62 billion by 2030, according to a new study. Join thought leaders from regulatory agencies, biotech, pharma, patients, and academia to discuss the latest advances, challenges, and forward-thinking . His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever. www.gobio.com/clinical-research/. Meghan started her career as a Masters level psychologist working within a medical care team treating patients with ALS and traumatic brain injury. Sun, 24 Apr 2022, 09:00 End. We look forward to welcoming you In-Person to Amsterdam for Clinical Trials Europe 2022 to celebrate our 21st birthday. Enhance site negotiations and pay with ease, with the industrys first Procure-to-Pay solution designed specifically for clinical trials. In 2021, ERT and Bioclinica merged to become Clario creating the broadest endpoint technology platform in the industry and enhancing our scientific expertise. 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. Axiom Exhibiting at Outsourcing in Clinical Trials Southeast 2022. Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. Agilex Biolabs operate a fully quality-assured, FDA-inspected laboratory (ISO/IEC17025 and OECD GLP). She has over 25 years of clinical development experience working at sites and in industry, and spanning multiple diseases, including oncology, ophthalmology, immunology, neurology, infectious and rare diseases. 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. To learn more , please visit our website - Technology as a methodology: Accelerating Clinical Development timelines. To learn more , please visit our website - The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. The therapeutic areas include: Cancer, CV, CNS and infectious diseases. PANEL DISCUSSION: The concept of DCT, is it the future? CLOSING KEYNOTE: FDAs role in maintaining a secure and resilient supply chain. Learn more atwww.clinone.com. Meraf Eyassu is a Executive Director of Clinical Operations at Terns Pharmaceuticals. He received his medical degree (MD) and his doctoral degree (PhD equivalent) from Justus-Liebig-Universitt Giessen, Germany, and his Master of Business Administration (MBA) from the Wharton School of Business, University of Pennsylvania, PA. Kunal Sampat is the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners. March. Add the event to your calendar. Ndidi Rickert is an experienced Quality Assurance leader with over 20 years of experience in the Pharmaceutical/Biotechnology industry. With presentations and panel discussions on all the hottest industry trends and outsourcing challenges. Founded in 2005, the companys cloud-based EDC, Direct Data Capture, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. To learn more , please visit our website - Mr. Larwood co-invented his first two commercial molecules before age 30. Our Precision Matching software mines millions of patient records, including unstructured physician notes, to pin-point eligible study patients in real-time. He worked in fortune 500 companies (Bristol-Myers Squibb Co, NJ-USA and Amgen, CA-USA), mid-size and startups/CROs (Discovery Partners Intl. http://www.kpslife.com. Caroline Cooper is the Director of Clinical Operations at CymaBay Therapeutics, Inc. with over 10 years of experience in clinical research. The company specializes in end-to-end services supporting drug discovery, precision medicine and clinical development for smarter clinical studies. Chemistry degree from Punjab University, Institute of Chemistry, Executive Director, Global Digital Quality Management Systems and Business Intelligence BeiGene, Executive Director, Global Medical Affairs Study Management, BioMarin Pharmaceuticals, Inc. Wendi Carroll received her Pharm D from the University of the Pacific. KEYNOTE: Seeing your site as a partner and identifying best practices for reducing site-burden, Seeing your site as a partner and identifying best practices for reducing site-burden, Clinical Operations leader with extensive bio-pharmaceutical and CRO industry experiences (20+years) *Develop and implement strategic Clin. http://www.yprime.com/, To learn more , please visit our website - 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. Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. Cultural consideration - translations, typical distance from site, etc. 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. Stream B: Clinical Innovation & Technology, A Fireside Chat on. YPrimescloud-based technology streamlines clinical trial data collection and management. 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 Digital Transformation of Clinical Trials the Importance of Data Accuracy. Our simulation-based protocol training prevents study errors, guarantees timely SIV, and frees up thousands of hours for your study team and site-staff. 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. Subsequently, Arun lead the Gastric-Immuno-Oncology Rare Disease Bispecific-T cell-Engager portfolio at Amgen on various aspects of clinical research operations. KPS Life (www.kpslife.com) is a stand-alone, global functional service provider (FSP) that offers a clinical outsourcing solution across all phases of clinical drug development. Examining how, even as a small company with limited resources you can successfully introduce time and cost saving QMS measures. Debashish has over 18 years of experience in the life sciences / clinical trials industry, including several leadership roles in Product Management. To learn more , please visit our website - She is currently Director of Patient Safety Medical Device for AstraZeneca and supports products across the enterprise. DGE invites you to return to the industry's first, most detailed, and most trusted conference on this topic - our 7th Decentralized & Hybrid Clinical Trials Summit. www.medpt.com. Are you choosing best in class or a bundle? https://www.nucleusnetwork.com/au/, To learn more , please visit our website - Medrio is the leading provider of eClinical technology for pharma, biotech, device, diagnostics, and animal health clinical trials. Orbis Clinical is a leading global life science recruitment partner. 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. TD2 offers fully integrated precision oncology clinical development solutions that combine the highest standards in clinical trials management, disruptive imaging, biomarker strategies, and unparalleled access to real-time patient data. 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. Clincierge reduces barriers to trial participation by employing patient-centric strategies to enhance the patient experience, increase patient retention, and improve clinical trial performance. Estela has supported her sister and her passion to help others has evolved to iLOOMinating, Engaging, Empowering and Supporting the community as a whole to take control of their healthcare. For more than 20 years, Axiom has delivered data-driven, powerful and cost-effective eClinical Solutions and Services dedicated to small-to-medium life science companies. 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. 4240 La Jolla Village Drive. Session Reserved for Worldwide Clinical Trials, Data Management: Programming and metrics in medical device studies, Vast experience of over 20 years in Quality, Regulatory, Processes Improvements and leading cross organization projects, VP Quality Assurance, Regulatory Affairs and Clinical at IceCure Medical, since September 2020, leading the company compliance and clinical affairs, Prior to joining IceCure Medical, held a position of Director of Quality, Regulatory and Customer Support at Applied Spectral Imaging (ASI) and Several positions at Carestream Health (formerly Orex Computed Radiography). 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. www.viroclinics.com. 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. Since 2003, Conversis has supported our life sciences clients to successfully and effectively communicate with patients and medical professionals worldwide. Understanding Digital and Device Safety Across a Large Organization, a Perspective of a Center of Excellence. Infectious disease clinical trials; Biometrics functional outsourcing; We also provide: Drug development consultancy and services to assist the development plan of molecules in early clinical phases; Clinical pharmacology units, bioanalytical laboratories and trial management offices across Europe and North America to perform your clinical . We have been driving the success of our clients, consultants, and employees in staffing and consulting services since 2004. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials. To learn more , please visit our website - Complimentary. Our customized and scalable solutions improve the quality and execution of clinical trials while mitigating costs and allowing clients to retain strategic control. http://www.mlm-labs.com. www.careaccess.com. How do we move forward from here? In 2010, he became a Supervisor Consumer Safety Officer (SCSO). www.prevailinfoworks.com. 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. http://www.cromsource.com/. Wayne resides in Miami, Florida. She is definitely not afraid of being the least popular girl in the room in order to support patient safety! To learn more , please visit our website - Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. We provide personalized patient logistics management, reimbursement, and convenience services to support clinical trial participants. elluminate softwareanddata driven serviceshave been used by more than 100 life sciencescompanieson over 500 clinical trials to reduce cycle time and improve data quality. Attendees. Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. Increasing inclusion in future trials for vulnerable populations with health disparities some success stories, Home visits have evolved since their inception in 2003, Services possible in 2023 an overview of what is possible today, Sourcing the right professionals for visits is essential to success, Addressing the reduced site pool challenge and focussing on sites you know can deliver, Overcoming hurdles with imaging centres with reduced staff when trying to qualify patients in a timely manner. Alexis Garelli has over 15 years of diverse healthcare information and pharmaceutical software technology experience. 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. Clinical Chemistry & Laboratory Medicine Conference. To learn more , please visit our website - OCT DACH Conference 2022 - Outsourcing in Clinical Trials. His most recent activity is as CEO and Founder of QuiVivePharma, a company he took from inception to a FDA face-to-face PreIND meeting in just 1 year. WCG measurably improves the quality and efficiency of clinical trials, helping biopharmaceutical companies, CROs, and institutions facilitate the development of new treatments and therapies for patients. eurofinscentrallaboratory.com/biopharma-services. https://www.advancedclinical.com/. She has led clinical development in dermatology and medical aesthetics for pharma/biotech, CROs, medical device and cosmetic companies including RAPT, Innovaderm, Premier Research, Allergan, Leo Pharma, and Murad. 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 . Our Provider Edition offers a CRO costing module and bid benchmarking. To learn more , please visit our website - To enquire about sponsorship opportunities for the conference, please contact: To enquire about speaking opportunities for the conference, please contact: Arena International is a global B2B events company for online casino players. May 02-03, 2016 Chicago, USA. Home / Events /. Francis has lead supplier oversight responsibilities for sponsors, CROs and clinical system vendors. http://www.iconplc.com/, To learn more , please visit our website - Why drugs fail in clinical trials? 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. She leads the scientific development of digital clinical measures and the modernization of clinical development models under the banner Technology As Methodology. Practiced Neuro-Oncology and General Neurology at the VA and Boston Medical Center. For more information, visitwww.eclinicalsol.com, or contact us atinfo@clinicalsol.com. This presentation will discuss: With increasing site staff/physician burnout and sites taking on less projects, we are still feeling the ripple effect of this on trials. Dr. Marszewska has experience with electronic data capture and data management in clinical research. 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. Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. Helping you take advantage of the speed of study start-up and R&D tax incentives in Australia and allow for smooth trial transition in the US. 11 th International Conference on Clinical Trials is scheduled to be held during November 09-10, 2023 at London, UK. Our leading clinical show will focus on providing delegates with practical take-aways and solutions to their most current operational and outsourcing challenges in clinical trials, this is an [] 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. 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. Our mission is to eliminate the barriers to clinical trials by bringing access to people where they live, work and are willing to engage. PCM TRIALSscreens, hires, trains and manages all of our own Certified Mobile Research Nurses who conduct clinical trial visits in the subjects homes. Medable offers the most flexible decentralized clinical trial platform streamlining trials for patients, sites, and clinicians whether in-clinic or at home. To learn more , please visit our website - https://www.threadresearch.com/. Our experts are ready to discuss how our solutions can best support your live studies. Dan Solisfrom TheFDAwill give the closing keynote. Tranquil Clinical Research is an early phase CRO with a fully accredited Hospital Phase I unit. To learn more , please visit our website -
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