PEG生物医学有限公司案例研究
PEG生物医学有限公司（PEG BIO），是一家苏州，中国生物制药公司，专门用于开发创新药品metabolic diseases包括2型糖尿病，肥胖和非酒精性肝炎。
While business between Peg Bio and Covance first started in 2014, the strength and depth of our relationship was highlighted in Spring 2019. In May that year, more than 400 Covance employees relocated to a new facility – theAland Centerin Zhangjiang Hi-Tech Park of Shanghai’s Pudong District- and Dr. Michael Xu, CEO of Peg Bio, was invited to deliver a speech for the new site opening ceremony. In his address, Dr. Xu expressed his gratitude for Covance’s service delivery, “among all of the collaborators, Covance is probably the best time keeping CRO we have worked with.”
挑战：中国制药需要加急发送数据集以获得FDA提交
It wasn’t long after Dr. Xu’s opening speech that a situation put Covance’s timeliness to the test. Over the summer months, Peg Bio submitted multiple studies carried out by Covance for review under the U.S Food and Drug Administration’s (FDA) Investigational New Drug (IND) program. The agency responded quickly to Peg Bio with a request that the submission be updated to include Standard for Exchange of Nonclinical Data（发送）数据集尽快地。
这不是处理多个监管机构的赞助商的罕见情况 - 特别是鉴于发送要求相对较新，而且专业知识和理解仍在整个行业中发展。
As Dr. Xu explained, “Our pipeline drugs target both China and western market, therefore in order to achieve approval from respective authorities, studies need to be performed to the highest quality that can be desired. To this end, both FDA and NMPA [China’s National Medical Products Administration] were largely satisfied with the reports generated from Covance.”
PegBio had successfully filed the study reports with their IND request, so how would they update their submission to include all of those SEND datasets now required by the FDA?
解决方案：利用全球发送团队在5个工作日内生成8个数据集
8月9日，经过便士王，Covance Sr.业务发展总监和PEG Bio之间的初步对话，Penny联系了Covance发送团队，向他们提供多个加急的发送数据集的迫切需要。
Covance发送团队理解PEG BIO将经历他们的IND提交是否被FDA拒绝并立即上班。跨多个网站和多学科团队的通信确保了存档数据，以发送格式提供贡献者数据，并最终生成完全集成的提交就绪的发送数据集。
PENNY协调努力，以获得跨社会的多个利益攸关方的所需承诺，并沿途告知PEG BIO。最后，8个发送数据集已在5个工作日内向客户发送。据派遣主管，杰森·皮泽，“这真的是一个卓越的团队努力......由一个真正出人的团队！”
团队的每个成员以及众多跨社会的其他成员都重新审查了本周的职责，并根据需要加班，以证明“我们专注于提供礼宾经验期待需求和超出预期的客人！”正如AsiaPAC VP所规定的，安德鲁弗莱明。
在收到所有的发送数据集s, Peg Bio Senior Director, Dr. Gao Sun noted, “Please allow me to use this opportunity to express my sincere gratitude to you [. . .] for the great service, team spirit and the client-centered attitude that have been shown this week to help us meet our FDA IND submission deadline. We understand that preparing 8 SEND datasets within one week is challenging or even impossible for many other CROs. I am really grateful that Covance is our service provider and we are extremely glad that we have chosen Covance for the service.”
Speed is incredibly vital in our industry. In the words of Covance CEO Paul Kirchgraber, “Patients can’t wait. Neither can we.” Thanks toCovance’s SEND expertise,我们可以自豪地说他们不必。
