Driving value through Standardization – Industry Challenges and Best Pract.ppt

下载文档 降价啦

5
0
约6.57千字
约 15页
2018-06-21 发布于河南
举报
版权申诉
保障服务

Driving value through Standardization – Industry Challenges and Best Pract.ppt

1、本文档共15页，可阅读全部内容。
2、有哪些信誉好的足球投注网站（book118）网站文档一经付费（服务费），不意味着购买了该文档的版权，仅供个人/单位学习、研究之用，不得用于商业用途，未经授权，严禁复制、发行、汇编、翻译或者网络传播等，侵权必究。
3、本站所有内容均由合作方或网友上传，本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺！文档内容仅供研究参考，付费前请自行鉴别。如您付费，意味着您自己接受本站规则且自行承担风险，本站不退款、不进行额外附加服务；查看《如何避免下载的几个坑》。如果您已付费下载过本站文档，您可以点击这里二次下载。
4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等，请点击“版权申诉”（推荐），也可以打举报电话：400-050-0827(电话支持时间：9:00-18:30)。

Driving value through Standardization – Industry Challenges and Best Pract

Copyright ? 2010 Accenture All Rights Reserved. Accenture, its logo, and High Performance Delivered are trademarks of Accenture. Copyright ? 2010 Accenture All Rights Reserved. Accenture, its logo, and High Performance Delivered are trademarks of Accenture. Driving value through Standardization – Industry Challenges and Best Practices Henry Levy, partner-Life Sciences RD European Lead * Copyright ? 2010 Accenture All Rights Reserved. Accenture, its logo, and High Performance Delivered are trademarks of Accenture. Topics What is Standardization? How much or how little? The value of Standardization Challenges Best Practices Summary * Copyright ? 2010 Accenture All Rights Reserved. Accenture, its logo, and High Performance Delivered are trademarks of Accenture. What is Standardization? Our industry is in the business of defining, creating, managing, and reporting data. Standardization of this data has been at the forefront of our functions agenda for the last 30 years… but… what is standardization? Is it using the same data for all trials? Is it naming our data consistently? Is it structuring our data consistently? Is it having semantic unambiguity? Is it to meet a regulatory guidance/requirement? The industry has defined it as one or all of these (or others) and it continues to change, and to challenge each of us * Copyright ? 2010 Accenture All Rights Reserved. Accenture, its logo, and High Performance Delivered are trademarks of Accenture. How much standardization? Submissions Outputs Derivations/ Imputations Collection Protocol Safety Efficacy When safety is efficacy PK/PD Across a Program Across a Disease Area/Indication Across a TA Across a Company Across the Industry * Copyright ? 2010 Accenture All Rights Reserved. Accenture, its logo, and High Performance Delivered are trademarks of Accenture. The Value of Standardization Efficiency Re-usability Transparency Ability to integrate Ability to share Ability to mine Ability to submit * Copyright ? 2010 Acc