{"title":"Industry Trends and Reports","description":"","products":[{"product_id":"parexel-biopharmaceutical-r-d-statistical-sourcebook-2018-2019-electronic-hard-copy","title":"PAREXEL Biopharmaceutical R\u0026D Statistical Sourcebook 2018\/2019 (Electronic + Hard Copy)","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003e\u003cstrong\u003ePAREXEL Biopharmaceutical R\u0026amp;D Statistical Sourcebook 2018\/2019\u003c\/strong\u003e is the leading resource for R\u0026amp;D statistics, trends, and proprietary market intelligence and analyses on the biopharmaceutical industry. Supported by thousands of graphs, illustrations, and analyses, the Sourcebook provides the latest intelligence on every aspect of biopharmaceutical development – from product discovery, to R\u0026amp;D performance and productivity, to time-to-market trends. With real-world analysis and key contributions from leading consultancies and experts, the \u003cstrong\u003e\u003cem\u003eSourcebook\u003c\/em\u003e\u003c\/strong\u003e includes:\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003eNew proprietary analysis on US clinical trial starts, segmented by therapeutic category, as well as overall active clinical trials\u003c\/li\u003e\n    \u003cli\u003eAssessments of personalized medicine\/companion diagnostics, biosimilars, orphan drugs, and other factors reshaping biopharma R\u0026amp;D today\u003c\/li\u003e\n    \u003cli\u003eThe latest analyses on clinical trial success rates, broken down by clinical trial phase and therapy area\u003c\/li\u003e\n    \u003cli\u003eAll-new analyses on who “owns” today’s R\u0026amp;D pipeline, R\u0026amp;D spending, and new drug\/biologics approvals by company size and type (pharma vs. biotech)\u003c\/li\u003e\n    \u003cli\u003eEmerging data on worldwide and company-specific R\u0026amp;D pipelines and product launch trends\u003c\/li\u003e\n    \u003cli\u003eNew analyses on emerging trends in pharma and biotech licensing deals and other partnerships critical to industry’s R\u0026amp;D pipeline\u003c\/li\u003e\n    \u003cli\u003eDrug approval statistics compiled from FDA, EMA, and other regulatory agencies\u003c\/li\u003e\n    \u003cli\u003eNew global R\u0026amp;D spending trends and other international R\u0026amp;D data from key markets\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong\u003eAnd much more!\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003eSpotlight analyses on emerging and re-emerging elements of industry’s R\u0026amp;D pipeline, including immunooncology, microbiome R\u0026amp;D, and cell\/gene therapy\u003c\/li\u003e\n    \u003cli\u003eAssessments of several emerging industry controversies, including drug pricing, the wisdom of ultra-rapid new drug reviews, and R\u0026amp;D “overcrowding” in some parts of the new drug pipeline\u003c\/li\u003e\n    \u003cli\u003eSpotlight analyses on the FDA’s expedited programs (breakthrough therapy, fast track, accelerated approval) and how their increased use is reshaping new drug development today\u003c\/li\u003e\n    \u003cli\u003eAnalyses on the state, nature, and sustainability of industry’s pipeline of R\u0026amp;D projects\u003c\/li\u003e\n    \u003cli\u003eAnalyses focused on the drug and biopharma markets and development pipelines within emerging countries, including brand new analyses on Korea and China\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong\u003ePAREXEL Biopharmaceutical R\u0026amp;D Statistical Sourcebook 2018\/2019\u003c\/strong\u003e is a must-have resource for the drug development industry. It is invaluable to executives and managers working in the pharma and biotech industries. The Sourcebook puts real-world data sets at your fingertips for presentations, reports, business development efforts, strategic meetings, and critical decision-making analyses.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003eThe 2018\/2019 electronic edition is also offered for individual users, small groups, business units, or company-wide access.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003eTo purchase the \u003cstrong\u003ePAREXEL Biopharmaceutical R\u0026amp;D Statistical Sourcebook 2018\/2019\u003c\/strong\u003e:\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003eCall: +1 781.972.5400 or toll-free in the U.S. 800.856.2556\u003c\/p\u003e\n\u003cp\u003eEmail: \u003ca href=\"mailto:customer.service@barnettinternational.com\"\u003ecustomer.service@barnettinternational.com\u003c\/a\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003eVisit the Publications section on barnettinternational.com\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eTestimonials:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cem\u003e“The PAREXEL R\u0026amp;D Sourcebooks are at the top of our list of books in the Louis Lasagna Library at the Tufts Center for the Study of Drug Development. 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It is invaluable to executives and managers working in the pharma and biotech industries. The Sourcebook puts real-world data sets at your fingertips for presentations, reports, business development efforts, strategic meetings, and critical decision-making analyses.\u003c\/p\u003e\n\u003cp\u003eThe 2018\/2019 edition is also offered in electronic format for individual users, small groups, business units, or company-wide access.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003eTo purchase the \u003cstrong\u003ePAREXEL Biopharmaceutical R\u0026amp;D Statistical Sourcebook 2018\/2019\u003c\/strong\u003e:\u003c\/p\u003e\n\u003cp\u003eCall: +1 781.972.5400 or toll-free in the U.S. 800.856.2556\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003eEmail: \u003ca href=\"mailto:customer.service@barnettinternational.com\"\u003ecustomer.service@barnettinternational.com\u003c\/a\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003eVisit the Publications section on barnettinternational.com\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eTestimonials:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cem\u003e“The PAREXEL R\u0026amp;D Sourcebooks are at the top of our list of books in the Louis Lasagna Library at the Tufts Center for the Study of Drug Development. They are the most heavily used items in the library.\" \u003c\/em\u003e  \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e— Sandra Peters, Louis Lasagna Library at the Tufts Center for the Study of Drug Development\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cem\u003e“This is an incredibly useful and reliable resource for anyone connected to the pharmaceutical and biotech industries: marketers, financial planners, investors, or researchers.”\u003c\/em\u003e  \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003e— Peter Barton Hutt, Covington \u0026amp; Burling\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52144022978925,"sku":"PRD18","price":545.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/BookStockImage_5214c091-f2fb-4bcb-b389-3b4d4040a3af.jpg?v=1758091983"},{"product_id":"good-clinical-practice-a-question-answer-reference-guide-electronic","title":"Good Clinical Practice: A Question \u0026 Answer Reference Guide 2020\/2021 (Electronic)","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003eThis industry-leading GCP reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of U.S. and international GCP standards for drugs, biologics, and medical device clinical trials. The completely updated and expanded guide includes:\u003c\/p\u003e\n\u003cul\u003e\n    \u003cli\u003eContinued updates focused on the impact of changes to ICH GCP E6 R2, enforcement of the revisions and its impact on clinical trial processes and systems, including Quality-by-Design and Risk-Based Quality Management (QM) expectations\u003c\/li\u003e\n    \u003cli\u003eChanges resulting from the implementation of the Common Rule including changes in informed consent requirements, the impact of Annex 13 on investigational product management\u003c\/li\u003e\n    \u003cli\u003eImpact of GDPR on eTMF management and common TMF regulatory findings\u003c\/li\u003e\n    \u003cli\u003eDozens of new Q\u0026amp;As including changes resulting from COVID-19\u003c\/li\u003e\n    \u003cli\u003eNew questions focused specifically on how Risk-based Quality Management (Section 5 of the Addendum) impacts monitoring activities\u003c\/li\u003e\n    \u003cli\u003eUpdates on the EU’s General Data Protection Regulation (GDPR) regulation and the MHRA 2018 Data Integrity Guidance\u003c\/li\u003e\n    \u003cli\u003eCoverage on updates to the “Common Rule” and NIH updates for clinical trials research\u003c\/li\u003e\n    \u003cli\u003eQuestions focused specifically on how Risk-Based Quality Management (Section 5 of the Addendum) impacts monitoring activities\u003c\/li\u003e\n    \u003cli\u003eUpdates to state- and country-specific regulations including the U.S., Brazil, Argentina, Peru, India and many others\u003c\/li\u003e\n    \u003cli\u003eOver 25 contributing authors with targeted expertise in QA, Monitoring, Compliance, Site Management, the Trial Master File, Data Management and many other core clinical research areas\u003c\/li\u003e\n    \u003cli\u003eExtensive graphs and charts on the latest inspection trends and findings! \u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/div\u003e","brand":"dynamicProvider2","offers":[{"title":"Commercial","offer_id":52195023356269,"sku":"GCP20E","price":69.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0924\/7961\/9437\/files\/BookStockImage.jpg?v=1758091733"},{"product_id":"good-clinical-practice-a-question-answer-reference-guide","title":"Good Clinical Practice: A Question \u0026 Answer Reference Guide 2020\/2021","description":"\u003cp\u003e\u003c\/p\u003e\u003cdiv class=\"leftColumn\"\u003e \u003c\/div\u003e\n\u003cdiv class=\"publicationContent\"\u003e\n\u003cp\u003eThis industry-leading GCP reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of U.S. and international GCP standards for drugs, biologics, and medical device clinical trials. 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