His PhD research at UC San Francisco established the foundation for PEGylated drugs widely used today. 11 clinical trials that will shape medicine in 2022 - Nature OCT Europe 2022 | SGS - SGSCorp Extensive Outsourcing and Contracts experience in the area of Clinical Development primarily at small to mid-size biotech organizations. May 02-03, 2016 Chicago, USA. Meghan joined a CNS-focused start up in RTP and has spent the last 15+ years working in the life science technology industry. AliveCor is a privately-held company headquartered in Mountain View, Calif. Consumer or Personal ECGs are ECG devices available for direct sale to consumers. To learn more , please visit our website - To learn more , please visit our website - The "Global Clinical Trial Outsourcing Market by Clinical Trial Phase, Therapeutic Area, End-user and Region: Competition Forecast and Opportunities to 2027" report has been added to . ), both from Duke University where I was also an undergraduate. Our Provider Edition offers a CRO costing module and bid benchmarking. Complimentary. Clinical Trial Conferences 2023 - mcdougallscientific.com 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. Can you share some of your workflow procedures? How do you arrange with and clean the large amounts of data generated? We provide personalized patient logistics management, reimbursement, and convenience services to support clinical trial participants. http://www.spauldingclinical.com/, To learn more , please visit our website - Dr. Yunis is a scientist with multidisciplinary training and experience in the mechanism of diseases. theactigraph.com. Exceptional quantitative and analytical skills with a passion for high quality outcomes and business profit. Precision medicine is in our blood, our cells, our genes, and our name. assisTek has been paving the way for integrating technology and data collection in clinical trials for over 25 years. To learn more , please visit our website - 21 - 22. 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. Earlier as a bench chemist, he was the first to make Iotrolan, a CT X-ray contrast agent, generic for decades, replaced in about 2005 by newer agents. Partnerships in Clinical Trials Europe 2021. Outsourcing In Clinical Trials East Coast 2022 - HealthManagement.org www.viroclinics.com. 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. This experience includes in vivo viral- vectored gene therapies, ex-vivo viral vectored and gene edited treatments for oncology and non-oncology patient communities, and RNA medicine modalities. To learn more , please visit our website - https://www.calyx.ai. San Diego Marriott La Jolla. Outsourcing in Clinical Trials East Coast - 10times www.pro-ficiency.com, To learn more , please visit our website - Spaulding Clinical Research is a global CRO providing Phase I IV drug development services to pharmaceutical and biotechnology companies. Conferences. Outsourcing in Clinical Trials: Medical Devices Europe 2023 About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . We develop new innovations, drive emerging therapies forward and improve patient lives. Altasciences helping sponsors get better drugs to the people who need them, faster. 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. With 2,000 annual trials and projects, around 200 active clients and global access to source drugs in over 60 countries,Myonex is your complete partner around clinical trials around the globe reliable, trusted and by your side. Or has the noise around DCT quietened? 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 [] Cognizing & mitigating Does AI-ML offer a solution? This holistic self-service platform provides faster data access and intelligent analytics, empowering clinical trial teams to think innovatively. THREAD is a leading provider of a proprietary, decentralized research platform and suite of supporting services used by biopharma, CROs and life science organizations to remotely capture data from participants and sites during, in-between and in lieu of in-clinic visits. The main program of the conference is discussion and debate on the outsourcing of clinical research. Ms. Lea is the Director of Global Patient Engagement and Advocacy for Acceleron, a wholly-owned Subsidiary of Merck. 7 - 9 November 2022, Amsterdam . His last company, TheraSim, trained over 1 million physicians worldwide and was sold to WebMD in 2013. Sun, 24 Apr 2022, 09:00 End. On the Calendar | PharmaVoice The global clinical trials outsourcing market size is expected to reach USD 67.62 billion by 2030, according to a new study. Headquartered in Sydney since 1996, Novotech has come to be recognised as the CRO of choice for many US and European biotechnology firms in the Asia Pacific. Dr. Cunningham came from academic background. www.signanthealth. These conferences closely focus on the advancements in clinical research and trials. . http://www.premier-research.com/, To learn more , please visit our website - With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact by driving quality, mitigating compliance risk, and enhancing patient engagement. Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. 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. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. Meghan serves as the VP, Clinical Trial Financial Management at Medidata driving roadmap and strategy across our Grants Manager and Site Payments products. Effective management of essential clinical trial documents using eTMF solutions. Arena International are delighted to announce Outsourcing in Clinical Trials Europe will be returning to Barcelona on the 3rd-4th May 2023! www.ledgerrun.com/, To learn more , please visit our website - Joined industry with a goal of developing digital and devices to improve patient care. The conference will bring together pharmaceutical and biotech experts to connect and explore solutions to current challenges associated with clinical trials. Why expert partners and staff matter; what metrics dont tell. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. www.prevailinfoworks.com. PANEL DISCUSSION THE PATIENT IMPACT: Patient recruitment, patient centricity & virtual trials Navigating the New Normal, QUICK FIRE ROUNDS: The Patient Perspective, Keynote Not just ticking a box: Outreach to minority groups is improving but the focus now is on establishing trust and relationships. To learn more , please visit our website - Learn more about and Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp. Dr Frances Rubenstein has worked in clinical data management for more than 20 years in both medical device and pharmaceutical companies. Outsourcing in Clinical Trials New England 2023 How do we move forward from here? Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. Advarra integrated solutions connects life sciences companies, CROs, research sites, investigators, and academia at the intersection of safety, technology, and collaboration. Choose from over 15 fully integrated modules on a single platform: EDC, DM, RTSM/IWRS, CTMS, Inventory Management, ePRO, eConsent, Patient Portal, AE/SAE Tracking, Safety Database, Central/Local Lab, Imaging Management, eTMF, and 24/7 Project and Clinical Data Reporting. Our innovative network of Mobile Research Sites, At Home Visits and Technology Enabled Virtual Visits are a unique blend of global DCT capabilities that can be deployed to better reach, recruit and retain diverse patient populations, while improving their clinical trial experience. https://www.slope.io/. She has worked with Calyx for over 7 years as a key strategic leader and director in IRT solutions and services. This session examines how scientific rigor can be applied to clinical outcome assessments (COAs) even though they are subjective. He works cooperatively and collaborates with Federal, State, and local agencies to ensure appropriate consumer protection. 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. Outsourcing In Clinical Trials - Texas 2022 - Ergomed PLC Importance of teams meeting face-to-face so that human touch and team cohesion isnt lost, Setting up rules and expectations creating space for communication, Strategies for prioritising work and tracking milestones with remote teams, Assessing the impact on the trial of remote vs in-person working; how to find a happy medium, How to best leverage remote trial management platforms, How to best utilize critical and non-critical data validation plans, What trial management services are best provided by the sponsor vs. CRO, How to best manage SOW/budget throughout the course of the trial. In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners. Proven ability to organize and manage late-stage development cross-functional teams completing projects on time with meticulous attention to detail. 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. How applying behavioral science insights can better inform the way we do patient engagement. Genentechwill give a case study session onpiloting health inequities and gender identity data why collecting this data now will aide you with your clinical trial. www.frontagelab.com. To learn more , please visit our website - 2022 edition of Outsourcing in Clinical Trials & Clinical Trial Supply East Asia Conference will be held at InterContinental Seoul Coex, Seoul starting on 29th November. She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. Collaterally with her Regional Food and Drug Director duties, Anne served as the acting program director for both the Biologics and Tobacco programs during significant planning phases for program alignment. www.harborclinical.com/. To learn more , please visit our website - ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). Clinical Services. https://www.discoverinternational.com/. Agilex Biolabs operate a fully quality-assured, FDA-inspected laboratory (ISO/IEC17025 and OECD GLP). United States, 94010, To learn more , please visit our website - Practiced Neuro-Oncology and General Neurology at the VA and Boston Medical Center. 4G Clinical, a leader in randomization and trial supply management (RTSM) for the global life sciences industry, is sponsoring the 2022 Outsourcing Clinical Trials DACH. To learn more , please visit our website - 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. . To learn more , please visit our website - 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. To learn more , please visit our website - http://kpslife.com/. To collaborate with CISCRP for your upcoming event, please contact Joan Chambers at jchambers@ciscrp.org or Lindsey Elliott at lelliott . 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. Outsourcing in Clinical Trials Southern California 2023 www.ACMGlobalLab.com. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. 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. Promedica International is a privately held, full-service CRO providing clinical trial services for the medical device, biotechnology and pharmaceutical industries. Wednesday, 28th Sep 2022 - Thursday, 29th Sep 2022 . 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. In this role, Mr. Chu develops, manages, and evaluates inspectional matters for DWCI covering all FDA import activities associated with air and sea port operations in the States of Hawaii, California, Nevada, Oregon, and Washington. Explore and learn more about Conference Series : World's leading Event Organizer. Lee King on LinkedIn: #octwestcoast2023 #clinicalresearch #lifesciences 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. She has over 22 years of experience overseeing GxP quality and compliance for all phases of drug development for biologics and small molecules. Register. With locations in the US and EU, Catalyst offers highly flexible and customized, customer-centric solutions from Global Resourcing and FSP, to Full Service Managed Solutions, with a focus on oncology product development. She has executed a variety of clinical trials involving therapeutic areas including autologous breast reconstruction, heart failure, hypertension, arrhythmia management and erectile dysfunction. Electronic clinical outcome assessments (eCOA)and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. This conference will focus on topics such as bioethics, regulations, patient recruitment, site selection, data integration & strategy, and many more. Digital Technology in Clinical Trials - DIA Global Contact: ESMO Registration Office; Phone: [+41 (0) 91 973 19 13]; Email: registration@esmo.org. Slope makes clinical trials boring by using real-time data to orchestrate operational complexity. ACM Global Laboratories is one of the largest global independent central labs in the industry. . 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. We will synthesize the scientific practices underpinning good instrument design and COA data collection methods and recommend next steps for addressing data collection challenges. 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. In that role, she built and led the commercial organization that developed go-to-market strategies for Potrero's Accuryn Monitoring System. This is because many conference attendees are likely to be active online casino, President, Healthcare Advocate, Looms For Lupus, Executive Director, Program Strategy, Rare Disease And Pediatrics, Premier Research, Inclusive Research and Health Equity - gRED ECD Clinical Operations,Genentech, Director Patient Innovation Center, Patient Insights, Parexel. Outsourcing in Clinical Trials & Clinical Trial Supply East Asia Conference Dr. Apfel is a California licensed physician with 20+ years of clinical experience in anesthesiology, critical care medicine, and emergency medicine. April 28-29, 2016 Dubai, UAE. 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 FDA reportedly rejected Neuralink clinical trials a year ago Discuss a pathway to extend biotech cash burn runway while still meeting Phase I objectives and meeting investor expectations! Gordon Chu is the Director of Investigations Branch at the Food and Drug Administration (FDA) Division of West Coast Imports (DWCI) within the Office of Enforcement and Import Operations (OEIO). Understanding Social Determinants of Health: Identifying the variables that burden trial participants how can we collect this data? As a Solutions Consultant with eClinical Solutions, Dan serves as a subject matter expert for the elluminate Clinical Data Cloud, the foundation of digital trials. Liza has extensive experience in managing and overseeing phase I-IV clinical trials globally as well as building and growing clinical operations teams in oncology, cardiovascular, metabolic and liver diseases, HIV and trials in gene therapy. http://www.medable.com/, To learn more , please visit our website - Running clinical trials in 2022: what you need to know To learn more , please visit our website - www.Clario.com. His mother started a foundation in 1998 and raised some $20M for research into vaccines against Valley Fever. Going the last millimeter: What you may not know about home visits. Events | 4G Clinical MaxisITs clinical data analytics platform is a purpose-fit solution developed to improve clinical trial performance, mitigate risk, and optimize clinical outcomes. 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. Conference series LLC Ltd Organizes 3000+ Global Events Every Year across . CROMSOURCE operates offices across Europe and North America. 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. She has an extensive background including several years of experience in field medical as well as over 6 years in medical affairs. Why having IRT experts involved in your study is important. 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. To learn more , please visit our website - http://www.clinicalink.com/. Our platform consists of 13 modules that cover every aspect of clinical trials, from project startup to pharmacovigilance. Network with 600+ clinical peers. With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/WRS) expertise at our core, our services are scalable via our strategic partnerships to provide full-service clinical trial solutions that are The Right Fit For You. Alexis Garelli has over 15 years of diverse healthcare information and pharmaceutical software technology experience. Our mission is to optimize the Clinical Trial Ecosystem, applying industry experience and the latest technology to streamline, secure, and enhance the interactions between sponsors, sites, CROs, and others involved in administering and operating clinical trials. Brandi has participated in numerous regulatory inspections as the Management representative, authored HHEs for all levels of products and issues and prides herself on being a patient advocate. Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables. She has actively participated in departmental preparation for the EU CTR implementation and is one of ICONs SMEs on this topic. Dan Solis is a recognized expert in FDA import operations and is the Assistant Commissioner for ORAs Office of Import Operations. www.deeplink-medical.com. http://www.arensia-em.com/. He is an advisor to several biotech companies. 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. www.rad-md.net. Additionally, Funwie collaborates with colleagues to co-create educational resources as a part of the core team of the Advancing Inclusive Research Site Alliance, which focuses on addressing disparities in clinical research. Compare and contrast the FDA, MHRA and TGA regulatory requirements for Phase I clinical entry. THREADs platform and supporting services are helping customers to shorten study launch timelines, reduce study budgets with Virtual Visits, and bring studies from the clinic to patients homes. Founded in 1985, Promedica International, a woman-owned corporation, is headquartered in Orange County, California. . Rhonda has more than 30 years of experience in FDA, starting as an ORA Investigator in Portland, OR before becoming a manager located in FDA's Minneapolis office. 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. 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. He is a member of DIA, ARVO and CDISC. www.agilexbiolabs.com. She is currently Director of Patient Safety Medical Device for AstraZeneca and supports products across the enterprise. Erin has over 20 years of clinical trial and pharmaceutical software technology experience . 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. Pharma/Medical Device/Biotech Delegate - Complimentary Pass Register Now. Theyll ensure your translations will be of the highest quality, on time, and within budget. http://www.heartcorsolutions.com. We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. Also within Genentech, she is a core member of the Advancing Inclusive Research Site Alliance and leads the company's LGBTQ+ Health equity strategies. Our platform allows site staff to pull data from various sources such as EHR and legacy systems automatically into their eCRFs (Fully agnostic) hence helping significantly reduce the double-data entry efforts (demographics, labs, vitals, adverse events, allergies, medications) and time spent with CRAs during monitoring visits. Read more. Our latest enhancements include patient genetic and biomarker matching to promote swift site identification and patient enrollment. Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Casimir's research on the development of the Duchenne Video Assessment (DVA) scorecards was published in PLOS ONE. Developing successful communication pathways in a more remote world. Our Sponsor Edition includes dedicated applications for clinical study planning and budgeting, outsourcing and forecasting. 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. The elluminate Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources. He has been actively involved on both sides of the business in managing CDMOs and CROs. 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.
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