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Centers of Excellence in Pharma: Driving Efficiency and Innovation

2025 年 3 月 25 日 In today's fast-paced pharmaceutical industry, Centers of Excellence (CoEs) have become vital…

Certara2025 年 3 月 25 日

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Protect Confidential Information in Investigational Drug Submissions

2025 年 3 月 20 日 Health regulatory agencies require pharmaceutical companies to protect study participants’ personal information…

Certara2025 年 3 月 20 日

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FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format

2025 年 3 月 19 日 The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the…

Certara2025 年 3 月 19 日

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药物开发中 PK/PD 建模的机器学习

Pharmacometricians can use machine learning for PK/PD modeling to help them characterize the safety and…

Certara2025 年 3 月 4 日

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美国 FDA MIDD 配对试点计划如何帮助赞助商

2025 年 2 月 28 日 For the past couple of decades, leading American institutions, pharmaceutical and biotechnology…

Certara2025 年 2 月 28 日

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Gain Nonclinical Drug Safety Insights with Real-Time Data Analysis

2025 年 2 月 24 日 Efficient drug development relies on informed decision-making. For toxicologists, having timely access…

Certara2025 年 2 月 24 日

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The History of Pinnacle 21

2025 年 2 月 21 日 It was late 2007. Mad Men was the hottest show on TV.…

Certara2025 年 2 月 21 日

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Investigator’s Brochure Writing: 5 Tips to Streamline Your SOC

Streamline developing a summary of changes for an Investigator’s Brochure, a document that summarizes the…

Certara2025 年 2 月 19 日

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Streamline Clinical Data Publication Under EMA Policy 0070

2025 年 2 月 14 日 The European Medicines Agency (EMA) Policy 0070 requires clinical data publication. Its…

Certara2025 年 2 月 14 日

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EU CTIS: 欧洲新临床试验信息系统

The EU CTIS is now fully implemented, replacing EudraCT as the central hub for clinical…

Certara2025 年 2 月 10 日

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Centers of Excellence in Pharma: Driving Efficiency and Innovation

Protect Confidential Information in Investigational Drug Submissions

FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format

药物开发中 PK/PD 建模的机器学习

美国 FDA MIDD 配对试点计划如何帮助赞助商

Gain Nonclinical Drug Safety Insights with Real-Time Data Analysis

The History of Pinnacle 21

Investigator’s Brochure Writing: 5 Tips to Streamline Your SOC

Streamline Clinical Data Publication Under EMA Policy 0070

EU CTIS: 欧洲新临床试验信息系统

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