Sandra J Hecker, Christopher Preston, MaryAnn Foote
{"title":"生产高质量的市场应用:生物技术公司与合同研究机构合作的策略。","authors":"Sandra J Hecker, Christopher Preston, MaryAnn Foote","doi":"10.1016/s1387-2656(03)09006-9","DOIUrl":null,"url":null,"abstract":"<p><p>Many biotechnology and pharmaceutical companies use clinical research organizations (CROs) to assist in the writing and preparation of clinical documents intended for submission to health authorities. Start-up companies often require the expertise of a CRO to prepare their first regulatory documents. Larger or more experienced companies often require CRO staff to assist at times of multiple simultaneous submissions. The timely production of high-quality new drug marketing applications requires close collaborations between the drug company and the CRO. The views of both CRO and industry in ensuring best practices are discussed.</p>","PeriodicalId":79566,"journal":{"name":"Biotechnology annual review","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/s1387-2656(03)09006-9","citationCount":"4","resultStr":"{\"title\":\"Production of high-quality marketing applications: strategies for biotechnology companies working with contract research organizations.\",\"authors\":\"Sandra J Hecker, Christopher Preston, MaryAnn Foote\",\"doi\":\"10.1016/s1387-2656(03)09006-9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Many biotechnology and pharmaceutical companies use clinical research organizations (CROs) to assist in the writing and preparation of clinical documents intended for submission to health authorities. Start-up companies often require the expertise of a CRO to prepare their first regulatory documents. Larger or more experienced companies often require CRO staff to assist at times of multiple simultaneous submissions. The timely production of high-quality new drug marketing applications requires close collaborations between the drug company and the CRO. The views of both CRO and industry in ensuring best practices are discussed.</p>\",\"PeriodicalId\":79566,\"journal\":{\"name\":\"Biotechnology annual review\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2003-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1016/s1387-2656(03)09006-9\",\"citationCount\":\"4\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Biotechnology annual review\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1016/s1387-2656(03)09006-9\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biotechnology annual review","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/s1387-2656(03)09006-9","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Production of high-quality marketing applications: strategies for biotechnology companies working with contract research organizations.
Many biotechnology and pharmaceutical companies use clinical research organizations (CROs) to assist in the writing and preparation of clinical documents intended for submission to health authorities. Start-up companies often require the expertise of a CRO to prepare their first regulatory documents. Larger or more experienced companies often require CRO staff to assist at times of multiple simultaneous submissions. The timely production of high-quality new drug marketing applications requires close collaborations between the drug company and the CRO. The views of both CRO and industry in ensuring best practices are discussed.