{"product_id":"the-clinical-audit-in-pharmaceutical-michael-hamrell-9780367399337","title":"The Clinical Audit in Pharmaceutical Development","description":"This blue-chip guide adds quality to the pharmaceutical clinical development process by detailing the need for, and stressing the importance of, an independent audit of clinical data to protect participants and validate study results.\u003cbr\u003eExamines the use of personal computers, the Internet, and third-party organizations to assist in data validation!\u003cbr\u003ePositioning the audit as the only reliable tool to verify that a drug has been shown to be safe and effective in clinical trials, The Clinical Audit in Pharmaceutical Development \u003cbr\u003e\u003cli\u003e recommends establishing auditing and quality assurance at the beginning of a clinical study \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003e describes Good Clinical Practices (GCPs) and the role of regulatory agencies in the review, validation, and auditing processes \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003e outlines the clinical process, from trial design through report writing \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003e compares and contrasts United States and international regulatory statutes \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003e identifies monitoring as the key to guaranteeing high-quality data \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003e focuses on the role of the clinical audit in achieving unity in a multinational study \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003e discusses the worldwide influence of the US Food and Drug Administration audit \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003e analyzes findings from previous FDA clinical audits to reveal trends and future directions \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003e provides guidelines for fraud detection and considers the ramifications of falsified data \u003cbr\u003e\n\u003c\/li\u003e\u003cli\u003e and more!\u003cbr\u003eConfirming that all clinical information has been properly collected and reported, The Clinical Audit in Pharmaceutical Development is a crucial reference for clinical and research pharmacists and pharmacologists; biostatisticians; clinical research associates, coordinators, and investigators; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.\u003c\/li\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Michael Hamrell\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 0367399334\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780367399337\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 09\/05\/2019\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 216\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.00lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.20h x 6.00w x 0.50d","brand":"Michael Hamrell","offers":[{"title":"Paperback","offer_id":48443385905407,"sku":"9780367399337","price":89.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_dadd7fe0-4d21-4c46-8017-1ef585086006.jpg?v=1777205171","url":"https:\/\/www.whiterainbookhouse.com\/products\/the-clinical-audit-in-pharmaceutical-michael-hamrell-9780367399337","provider":"WR Book House","version":"1.0","type":"link"}