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Manufacturing and Natural Resources. ReportLinker, New York, Feb. 22, 2023 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Real World Evidence Solutions Market Size, Share & Industry Trends Analysis Report By Component, By Therapeutic Area, By End-user, By Application, By Regional Outlook and Forecast, 2022 - 2028" - https://www.reportlinker.com/p06422625/?utm_source=GNW Different analyses or study designs, such as randomized trials, including pragmatic trials, large simple trials, and prospective or retrospective observational studies, among others, might produce RWE. The largest market share of 48.6% was held by on-premises delivery mode in 2022. Show publisher information (IDC, 2020) $72.8 billion - the projected worldwide AR/VR market size in 2024. Since the inception, we have only thrived to research, analyze, and present the critical market data with great attention to details. As a Premium user you get access to background information and details about the release of this statistic. In December 2021, TriNetX LLC announced the launch of Diversity Lens, an analytic feature that enables healthcare and life sciences organizations to make use of real-world data to comprehend and address racial and ethnic differences in clinical trial patient participation. - 257) According to estimates, cancer, obesity, cardiovascular diseases, and diabetes, all of which are on the rise, are responsible for over half of all fatalities from chronic diseases. The oncology segment dominates owing to the rising prevalence of cancer and the increasing number of clinical trials and studies focused on cancer treatment and prevention. 2.1.1 SECONDARY DATA FIGURE 43 REAL WORLD EVIDENCE SOLUTIONS MARKET RANKING, BY KEY PLAYER, 2021 12.2.5 FLATIRON HEALTH, 13 APPENDIX (Page No. As a Premium user you get access to the detailed source references and background information about this statistic. The total size of the real world evidence solutions market was arrived at after data triangulation from three different approaches- revenue share analysis, segmental extrapolation, and primary interviews. 10.3.4.1 The demand for RWE in Italy is high due to the widespread use of pay-for-outcomes 12.1.3 OPTUM INC. (A SUBSIDIARY OF THE UNITED HEALTH GROUP, INC.) Because of these benefits, the use of real-world evidence solutions is increasing in drug and medical device R&D activities. RWE data is needed for new drugs to successfully pass through clinical phases. FDA uses RWD and RWE to monitor postmarket safety and adverse events and to make regulatory decisions. statistic alerts) please log in with your personal account. The real world evidence solutions market is dominated by a few globally established players such as IQVIA Holdings Inc. (US), IBM Corporation (US), OPTUM Inc. (US), Icon Plc (Ireland), Syneos Health Inc. (US), and Parexel International Corporation (US). TABLE 114 REST OF EUROPE: REAL WORLD EVIDENCE SOLUTIONS MARKET, BY COMPONENT, 20202027 (USD MILLION) - 50) 11.6 COMPANY FOOTPRINT To meet the demands for both drug discovery and development, pharmaceutical and biopharmaceutical companies are opting for fully integrated or functional outsourcing services, from the early development stage to the late-stage development phase. 12.1.20 MEDPACE HOLDINGS INC. TABLE 99 FRANCE: RWE MARKET, BY END USER, 20202027 (USD MILLION) Many pharmaceutical, biotechnology & medical device companies aspire to join the fight against COVID-19 by applying human data science to support research activities related to health system issues in collaboration with the world's leading academic researchers. Data marketplaces and exchanges provide single platforms to consolidate third-party data offerings. : COMPANY SNAPSHOT (2021) United States Real-World Evidence (RWE) Solutions Market Report 2022: Market is Expected to Grow at a CAGR of 13% from 2021 to 2028 to Reach $2.01 Billion by 2028 - ResearchAndMarkets.com March 11 . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 12.1.4 ICON PLC. TABLE 87 UK: RWE SOLUTIONS MARKET, BY COMPONENT, 20202027 (USD MILLION) This growth in R&D expenditure, fueled by the need for numerous preclinical and clinical services during the drug development process, is expected to drive the growth of the real world evidence solutions market. The figures prior to 2020 are based on IDC's forecast from late 2018. 12.1.15 PERKINELMER INC. 12.1.13 TRINETX LLC As real world data frequently needs to combine data from multiple technology architectures including data from healthcare sources, patient reported outcomes, electronic data capture (EDC) or a mobile health technology, a highly specialized infrastructure is needed. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed wherever applicable. ReportLinker A paid subscription is required for full access. TABLE 80 GERMANY: REAL WORLD EVIDENCE SOLUTIONS MARKET, BY COMPONENT, 20202027 (USD MILLION) Using RWE and RWD can inform better protocol design, thereby reducing the number of costly protocol amendments, and can enable the creation of synthetic control arms to accelerate trial execution and decrease overall costs. 12.1.6 PAREXEL INTERNATIONAL CORPORATION R&D is very important in the pharmaceutical business in particular. TABLE 129 JAPAN: RWE SOLUTIONS DATA SETS MARKET, BY TYPE, 20202027 (USD MILLION) 10.3.2 UK The Americas contributed 40.2% of the overall market size estimate. Browse in-depth TOC on" Real World Evidence Solutions Market - Global Opportunity Analysis And Industry Forecast (2021-2028)"173 Tables47 Figures214 Pagesclick here:https://www.meticulousresearch.com/product/real-world-evidence-solutions-market-4954, (Note: Other Disparate Datasets include data generated from mobile devices, wearable devices, and social media), Amidst this crisis, Meticulous Researchis continuously assessing the impact of COVID-19 pandemic on various sub-markets and enables global organizations to strategize for the post-COVID-19 world and sustain their growth. For instance, in April 2020, ICON plc (Ireland) signed a three-year agreement with Pfizer Inc. (U.S.), under which ICON provides expertise in the planning, execution, management, and conduct of clinical trials. 8.2.3.1 Growing prevalence of neurological disorders to drive growth Who will be your Top Customer; what will make them switch? 12.2 OTHER PLAYERS 10.3.6 REST OF EUROPE 12.1.11 SAS INSTITUTE Webinar White paper The market is expected to expand at a CAGR of 8.2% from 2023 to 2030. TABLE 124 ASIA PACIFIC: REAL WORLD EVIDENCE SOLUTIONS MARKET, BY APPLICATION, 20202027 (USD MILLION) TABLE 10 INFLUENCE OF STAKEHOLDERS ON BUYING PROCESS FOR TOP 3 APPLICATIONS 6.8.3 JURISDICTION ANALYSIS: TOP APPLICANTS (COUNTRIES) FOR PATENTS IN THE REAL WORLD EVIDENCE SOLUTIONS MARKET In addition, with the development of sophisticated, new analytical capabilities, we are better able to analyze these data and apply the results of our analyses to medical product development and approval. Defend your Market Share or Win Competitors. 10.4.1 JAPAN Between 2018 and 2025 the size of real-time data in the global datasphere is expected to expand tenfold, from five zettabytes to 51 zettabytes. 6.7.3 ASIA PACIFIC The data for GDP at purchasing power parity has also been rebased using the new International Comparison Program price surveys and extrapolated to 2007. TABLE 186 COGNIZANT TECHNOLOGY SOLUTIONS CORPORATION: BUSINESS OVERVIEW 12.1.1 IQVIA HOLDINGS INC. 4.2 ASIA PACIFIC: RWE SOLUTIONS MARKET, BY END USER AND COUNTRY (2021) Real-World Evidence (RWE) is the clinicalevidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD. The pharmaceutical, biotech, and medical device industries are facing a list of unprecedented challenges led by the global economic crisis, coronavirus pandemic, and concerns about escalating healthcare costs. Payers infrequently used real-world evidence (RWE), or information on how treatments work in the real world, to guide their medication coverage and reimbursement decisions. TABLE 11 KEY BUYING CRITERIA FOR TOP 3 END USERS, 7 REAL WORLD EVIDENCE SOLUTIONS MARKET, BY COMPONENT (Page No. TABLE 51 NORTH AMERICA: REAL WORLD EVIDENCE SOLUTIONS MARKET, BY COUNTRY, 20202027 (USD MILLION) TABLE 21 CLAIMS DATA SETS OFFERED BY KEY MARKET PLAYERS TABLE 143 INDIA: RWE SOLUTIONS DATA SETS MARKET, BY TYPE, 20202027 (USD MILLION) The healthcare companies segment witnessed the maximum revenue share in the real world evidence solutions market in 2021. FIGURE 8 CAGR PROJECTIONS: OVERALL RWE SOLUTIONS MARKET 7.3.1.5 Registry-based data sets TABLE 97 FRANCE: RWE SOLUTIONS MARKET, BY APPLICATION, 20202027 (USD MILLION) TABLE 2 RISK ASSESSMENT: REAL WORLD EVIDENCE SOLUTIONS MARKET This research study involved the extensive use of both primary and secondary sources. TABLE 167 REAL WORLD EVIDENCE SOLUTIONS MARKET: DETAILED LIST OF SMALL & MEDIUM PLAYERS TABLE 45 REAL WORLD EVIDENCE SOLUTIONS MARKET, BY END USER, 20202027 (USD MILLION) TABLE 166 OVERVIEW OF STRATEGIES ADOPTED BY PLAYERS IN THE REAL WORLD EVIDENCE SOLUTIONS MARKET 11.6.1 END-USER FOOTPRINT OF COMPANIES 6.5.2.1 North America TABLE 12 REAL WORLD EVIDENCE SOLUTIONS MARKET, BY COMPONENT, 20202027 (USD MILLION) FIGURE 58 CLINIGEN: COMPANY SNAPSHOT (2021) 7.3.1 DISPARATE DATA SETS ,5002,7503,0003,5004 . Smart Buildings Market Size in 2022 with Top Countries Data, SWOT Analysis, Share, Top Manufactures, Growth Insights and Forecasts to 2027 | Honeywell, Siemens, Schneider Electric, Johnson Controls TABLE 137 CHINA: DISPARATE DATA SETS MARKET, BY TYPE, 20202027 (USD MILLION) The global real world evidence solutions market in terms of revenue was estimated to be worth $1.5 billion in 2022 and is poised to reach $2.9 billion by 2027, growing at a CAGR of 15.2% from 2022 to 2027. TABLE 85 GERMANY: RWE MARKET, BY END USER, 20202027 (USD MILLION) You need at least a Starter Account to use this feature. 10.3 EUROPE FIGURE 54 ELEVANCE HEALTH: COMPANY SNAPSHOT (2021) 8.2.1 ONCOLOGY This paper examines selected macroeconomics variables' impact on foreign direct investment inflows in Malaysia during Pre- and Post- COVID-19. With the given market data, MarketsandMarkets offers customizations as per your companys specific needs. TABLE 54 NORTH AMERICA: DISPARATE DATA SETS MARKET, BY TYPE, 20202027 (USD MILLION) This data holds potential to allow us to better design and conduct clinical trials and studiesin the health care setting to answer questions previously though infeasible. The reimbursement/coverage and regulatory decision making segment recorded a substantial revenue share in the real world evidence solutions market in 2021. TABLE 106 ITALY: RWE MARKET, BY END USER, 20202027 (USD MILLION) Pharma data analyses extract insights, inform new strategies and provide KPI tracking. These variations can affect reimbursement, patient access, and potentially healthcare outcomes across health plans during the pharmaceutical technology assessment (PTA) process. 9.3 HEALTHCARE PAYERS 8.5.1 GROWING USE OF RWE SOLUTIONS TO DEVELOP ECONOMIC AND BUDGET IMPACT MODELS Following a detailed secondary and primary research and an in-depth . TABLE 1 EXCHANGE RATES UTILIZED FOR CONVERSION TO USD TABLE 83 GERMANY: RWE SOLUTIONS MARKET, BY APPLICATION, 20202027 (USD MILLION) 10.3.5 SPAIN 5.2 MARKET DYNAMICS Based on our analysis, the global market exhibited an average growth of 12.5% in 2020 as compared to 2019. 2.5 ASSUMPTIONS FOR THE STUDY FIGURE 20 NORTH AMERICA WILL CONTINUE TO DOMINATE THE REAL WORLD EVIDENCE SOLUTIONS MARKET DURING THE FORECAST PERIOD Information about your device and internet connection, like your IP address, Browsing and search activity while using Yahoo websites and apps. TABLE 147 INDIA: REAL WORLD EVIDENCE SOLUTIONS MARKET, BY END USER, 20202027 (USD MILLION) 11.9.1 FDA APPROVALS/SERVICE ENHANCEMENTS 8.3.1 INCREASING RESEARCH IN MEDICAL DEVICE DEVELOPMENT TO DRIVE DEMAND FIGURE 35 TOTAL E-PRESCRIPTIONS AND CONTROLLED SUBSTANCE PRESCRIPTIONS IN THE US (2018-2021) 6.1.1 EMERGING ROLE OF WEARABLE DEVICES TABLE 70 CANADA: RWE SOLUTIONS IN DRUG DEVELOPMENT AND APPROVALS MARKET, BY TYPE, 20202027 (USD MILLION) FIGURE 24 UTILIZATION OF WEARABLES IN CLINICAL TRIALS, BY THERAPEUTIC AREA, 2019 To know about the assumptions considered for the study, Request for Free Sample Report. * The data was taken from various publications released over several years: Forecast for the years 2018 and 2019 as of 2018; Forecast for 2020 as of May 2021; Forecast for 2021 to 2025 as of March 2021 based on figure for 2020 provided by the source. The RWE Solutions Market is expected to grow at a CAGR of 11.8% from 2022 to 2029 to reach $4.93 billion by 2029. TABLE 23 PHARMACY DATA SETS OFFERED BY KEY MARKET PLAYERS Location: New York, New York Aetion operates as a real-world evidence and analysis platform to assist the healthcare industry. 10.2.2 CANADA After the completion of each approach, the weighted average of these approaches was taken based on the level of assumptions used in each approach. TABLE 73 EUROPE: RWE SOLUTIONS MARKET, BY COMPONENT, 20202027 (USD MILLION) Based on stated demand for carbon credits, demand projections from experts, and the volume of negative emissions needed to reduce emissions in line with the 1.5-degree warming goal, annual global demand for carbon credits could reach up to 1.5 to 2.0 gigatons of carbon dioxide by 2030 and up to 7 to 13 gigatons by 2050.The market size in 2030 . 4.3 RWE SOLUTIONS MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES 10.4.3 INDIA Key companies profiled in the report include IBM Corporation, Oracle Corporation, Medpace Holdings, Inc., IQVIA Holdings, Inc., ICON plc, PerkinElmer, Inc., Parexel International Corporation (Phoenix Parentco, Inc.), PPD, Inc. (Thermo Fisher Scientific, Inc.), UnitedHealth Group, Inc. (Optum, Inc.), and Syneos Health, Inc.Strategies Deployed in Real World Evidence Solutions MarketDec-2022: IBM signed an agreement to acquire Octo, a digital transformation service provider exclusively serving the U.S. federal government. FIGURE 27 ECOSYSTEM COVERAGE: PARENT MARKET (HEALTHCARE IT SOLUTIONS) You can change your choices at any time by visiting your privacy controls. TABLE 67 CANADA: RWE SOLUTIONS DATA SETS MARKET, BY TYPE, 20202027 (USD MILLION) RWD has been used increasingly to map the progression of the disease and to discover vaccines and immediate treatments. The segments growth is linked to the widespread use of real-world evidence services by healthcare organizations and businesses involved in biotechnology and pharmaceuticals. $6.36 billion will be spent in the consumer segment. 1.4 LIMITATIONS Gain clarity and insights into what's happening in your target market. The report presents a detailed assessment of the real world evidence solutions market, along with qualitative inputs and insights from MarketsandMarkets. Download Report. 1.2 MARKET DEFINITION TABLE 57 NORTH AMERICA: RWE SOLUTIONS MARKET, BY END USER, 20202027 (USD MILLION) Then you can access your favorite statistics via the star in the header. In order to prove value, companies need strong evidence of lifecycle management capabilities. The size of the professionally managed real estate market also continued to grow in 2021, rising to USD 11.4 trillion from USD 10.5 trillion in 2020. 10.2.1 US Learn more about how Statista can support your business. They are derived from electronic health records (EHRs), claims and billing activities, product and disease registries, etc. TABLE 144 INDIA: DISPARATE DATA SETS MARKET, BY TYPE, 20202027 (USD MILLION) Domain News - Provides the latest real estate and property market news in Australia. With this acquisition, the company aimed to strengthen its software portfolio through automation, data, and AI in order to address the full spectrum of observability.Nov-2021: PerkinElmer unveiled PKeye, a workflow monitor platform for remotely managing and monitoring workflows. Note 2: Other primaries include sales managers, marketing managers, and product managers. And of course, much more. 2.4 MARKET RANKING ANALYSIS View listing photos, review sales history, and use our detailed real estate filters to find the perfect place. TABLE 160 MIDDLES EAST & AFRICA: RWE SOLUTIONS MARKET, BY COMPONENT, 20202027 (USD MILLION) TABLE 90 UK: REAL WORLD EVIDENCE SOLUTIONS MARKET, BY APPLICATION, 20202027 (USD MILLION) FIGURE 23 NUMBER OF CLINICAL TRIALS STARTED DURING 20152020 This platform is an innovative approach that enables customers in the life sciences industry to discover powerful new insights, drive smarter decision-making, and get treatments to patients faster. Together both companies aimed at providing technology-enabled, insights-powered solutions to biopharma customers by integrating RxDataSciences AI and data-science capabilities with its therapeutic expertise.Sep-2021: Syneos Health took over StudyKIK, technology-enabled clinical trial recruitment, and retention company. Support from regulatory bodies for using Real World Evidence Solutions (RWE) and an increase in R&D spending are anticipated to boost market growth. Accessed March 02, 2023. https://www.statista.com/statistics/871513/worldwide-data-created/, IDC, and Statista. 10.2.2.1 Growing number of clinical trials in Canada to drive market growth TOP 10 COMPANIES IN REAL-WORLD DATA (RWD) MARKET 0 By Meticulous Research on December 12, 2022 Healthcare, Pharmaceutical According to this latest publication from Meticulous Research, the real-world data (RWD) market is expected to register a CAGR of 7.4% from 2022 to 2029 to reach $1.66 billion by 2029. Please create an employee account to be able to mark statistics as favorites. 6.7.3.1 China TABLE 91 UK: RWE SOLUTIONS IN DRUG DEVELOPMENT AND APPROVALS MARKET, BY TYPE, 20202027 (USD MILLION) RWD can come from a number of sources, for. This is because pharmaceuticals and biotech companies are becoming more aware of the potential value of RWE in life-cycle management and drug development, as well as how it can lower the cost of clinical trials and boost innovation efficiency.COVID-19 Impact AnalysisThe infectious coronavirus could economically impact most industries, including the pharmaceutical sector. 10.2.1.1 The US accounted for the largest share of the North American market One of its mandates was for the US FDA to develop a framework to evaluate how data from sources other than clinical trials can be used to support drug approvals. 7.3.1.2.1 Growing need to understand the economic benefits of drug reimbursement by payers to drive growth The market is projected to grow from USD 271.83 billion in 2022 to USD 655.53 billion by 2029, exhibiting a CAGR of 13.4% during the forecast period. 13.3 CUSTOMIZATION OPTIONS The pressures are more significant in the oncological department, where high-cost agents with similar effects compete in the market. The acquisition would combine the companys consulting expertise and technical capabilities with Octos team that enable federal clients to transform faster and better serve citizens.Jul-2022: IBM took over Databand, a leader in data observability software. TABLE 25 PATIENT-POWERED DATA SETS OFFERED BY KEY MARKET PLAYERS Despite all positives, the key players experienced an initial shrinkage in the market due to uncertainties associated with the impact of the COVID-19 pandemic. Market Overview: The global real-world evidence solutions market size reached US$ 1.6 Billion in 2022. 6.5.1 AVERAGE SELLING PRICE 12.2.4 TEMPUS LABS INC. As soon as this statistic is updated, you will immediately be notified via e-mail. 5.2.1.4 Increased R&D spending for the development of new pharmaceutical products and medical devices 2.1.2.1 Key data from primary sources June 7, 2021. Real-world data are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. The increasing emphasis on clinical value evidence for choices to offer coverage and the rising cost of therapy is responsible for expanding the reimbursement/coverage and regulatory decision-making segment. Real-world data (RWD) has become a powerful tool in the life sciences industry by pharmaceutical, biotechnology, & medical device companies; healthcare payers; healthcare providers; and other end users (academic research institutions, patient advocacy groups, regulators, and health technology assessment agencies) to add value at every stage of 10.5.1 INCREASED HEALTHCARE EXPENDITURE TO SUPPORT MARKET GROWTH TABLE 39 DRUG DEVELOPMENT AND APPROVALS MARKET IN IMMUNOLOGY, BY COUNTRY, 20202027 (USD MILLION) 10.6.1 GROWING AVAILABILITY OF HEALTHCARE FUNDING IN THE MIDDLE EAST OFFERS OPPORTUNITIES FOR MARKET GROWTH 6.7.3.2 Japan Available: https://www.statista.com/statistics/871513/worldwide-data-created/, Volume of data/information created, captured, copied, and consumed worldwide from 2010 to 2020, with forecasts from 2021 to 2025, Available to download in PNG, PDF, XLS format, Global IT spending forecast 2012-2023, by segment, IT spending year-over-year growth worldwide 2016-2023, by segment, Worldwide storage revenue growth 2017-2027, Worldwide storage spending per employee 2016-2028, Information archiving solutions market size worldwide 2014-2026, Amount of data created, consumed, and stored 2010-2020, with forecasts to 2025, Worldwide data storage unit revenue 2014-2027, Worldwide data storage unit revenue growth 2015-2027, Sales volume of data storage units worldwide 2014-2027, Data storage units volume growth worldwide 2015-2027, Per unit price of data storage units worldwide 2014-2027, DRAM market revenue worldwide 2010-2022, by quarter, NAND flash market revenue worldwide 2010-2022, by quarter, Market revenue from external enterprise storage systems 2009-2021, by quarter, NAND flash manufacturers revenue worldwide 2010-2022, by quarter, Enterprise external storage systems factory revenue worldwide 2009-2021, by quarter, Enterprise external storage systems vendor market share 2008-2021, by quarter, Spending on cloud and data centers 2009-2021, by segment, Share of IT infrastructure spending worldwide 2014-2024, by deployment type, Worldwide enterprise cloud strategy 2017-2022, Global unstructured data storage repositories used 2021, Global cloud storage security issues 2020-2021, by organization size, Global cloud identity and access management issues 2020-2021, by organization size, Smart building data volume collected globally 2010-2020, Data economy's impact on GDP in EU and UK 2018-2025, Number of data users in the EU and UK 2016-2020 and 2025, Data companies' revenues in the EU and UK 2016-2020 and 2025, Internet data consumption in Asia Pacific 2015-2020 by selected countries, Total Enterprise datasphere size by industry worldwide 2018, Internet data consumption in Indonesia 2013-2020, Internet data consumption in China 2013-2020, Value of data economy in EU and UK 2016-2020 and 2025, Average data consumption per user in one quarter in Indonesia 2019, Data as a share of total mobile service revenue in China 2004-2014, Mobile data as share of total telecom revenue in the United Kingdom (UK) 2004-2014, Monthly mobile data consumption volume by SIM card in France 2008-2017, All-flash array price in Taiwan Q3 2016-Q3 2018, Visual data room market value worldwide 2018-2027, Distribution of smartphone contracts with major providers Japan 2020, by data volume, Number of data professionals in the U.S. 2016-2020, Number of data professionals in the EU and UK 2016-2020 and 2025, Distribution of budget SIM cards for smartphones Japan 2020, by data volume, Volume of data/information created, captured, copied, and consumed worldwide from 2010 to 2020, with forecasts from 2021 to 2025 (in zettabytes), Find your information in our database containing over 20,000 reports. 10.2 NORTH AMERICA Science and Research Special Topics, Recalls, Market Withdrawals and Safety Alerts, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products, Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products, Framework for FDAs Real-World Evidence Program, Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products, Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products, Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, Submitting Documents Utilizing Real-World Data and Real-World Evidence to FDA for Drugs and Biologics, Use of Electronic Health Records in Clinical Investigations, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. 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