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DIA 2024 Cocktail Reception

Location: Roy’s San Diego Waterfront Restaurant, 333 W. Harbor Drive, San Diego, CA 92101 Certara is a proud to be exhibiting at this year’s DIA Annual Meeting. We are pleased to invite you to this exclusive client-only reception. Space is limited, so be sure to register today! Date: 2024년 6월 18일 화요일 Event Type: Cocktail … Continued

https://www.certara.com/dia-2024-cocktail-reception/

Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates

In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies deliver cytotoxic small-molecule drug payloads to cancer cells. The cytotoxic payload attaches to a monoclonal antibody (designed for binding to the target) through a linker.   Having a solid clinical pharmacology strategy is essential to successfully developing these therapies. The US … Continued

https://www.certara.com/blog/reflections-on-the-new-fda-clinical-pharmacology-guidance-for-antibody-drug-conjugates/

CERTARA & CLOUDSCIENTIFIC ACCELERATE AI FOR DRUG DEVELOPMENT IN CHINA

Partnership will provide biopharmaceutical companies with advanced tools and solutions needed to expedite research   RADNOR, PA – 5월 10, 2024 – Certara, Inc., a global leader in model-informed drug development (MIDD), today announced a new distributor agreement with Cloudscientific. The agreement brings Certara’s leading discovery informatics platform, D360, and Certara’s secure and flexible GPT … Continued

https://www.certara.com/announcement/certara-cloud-scientific-accelerate-ai-for-drug-development-in-china/

Certara Reports First Quarter 2024 Financial Result

Reiterates Full Year 2024 Financial Guidance PRINCETON, N.J.— May 7, 2024– Certara, Inc. 글로벌 바이오시뮬레이션 선두기업(Nasdaq: CERT), a global leader in biosimulation, today reported its financial results for the first quarter of fiscal year 2024. First Quarter Highlights: “I am pleased with our first quarter financial results, steered by solid execution across both software and services,” said William … Continued

https://www.certara.com/pressrelease/certara-reports-first-quarter-2024-financial-result/

A Best Practice Guide to CDISC SDTM Mapping

CDISC SDTM mapping made simple Is a drug working? Are there side effects? Is it safe to continue with a trial?   These questions can be answered by clear, comprehensive data analytics. But to get this information, you must first produce quality CDISC SDTM datasets. Mapping your clinical trial data to CDISC’s SDTM format is no … Continued

https://www.certara.com/fact-sheet/a-best-practice-guide-to-cdisc-sdtm-mapping/

Guide Download – A Best Practice Guide to CDISC SDTM Mapping

Make informed decisions with real-time SDTM compliant data How about a free demo of Pinnacle 21 Clinical Data Management & Automation Suite? Complete the form to book your no-obligation demo of Pinnacle 21… and see how you can increase the speed and quality of your clinical trial submission data! Trusted by leading drug developers

https://www.certara.com/thank-you-guide-download-a-best-practice-guide-to-cdisc-sdtm-mapping/

How Chinese CRO, Zhejiang Longcharm Biomedical Technology Uses Pinnacle 21 Enterprise to Optimize Sponsors’ Non-clinical and Clinical Regulatory Affairs

Voice of the Customer Founded in 2016, Zhejiang Longcharm Biomedicine Technology Co., Ltd. provides one-stop R&D outsourcing services for the Chinese pharmaceutical industry. They can support BA/BE/PK clinical testing and data analysis services that comply with Chinese and American regulatory requirements for both novel and generic drug development programs. In 2023 July, Zhejiang Longcharm Bio-medical … Continued

https://www.certara.com/case-study/chinese-cro-uses-pinnacle-21-to-optimize-sponsors-clinical-regulatory-affairs/

EU CTIS: Europe’s New Clinical Trial Information System

EudraCT has been Europe’s clinical trial database for almost twenty years. But, now it’s the time to say goodbye to EudraCT and hello to the new Clinical Trial Information System (CTIS). CTIS will be the single entry point for submitting, assessing, authorizing, supervising, and reporting clinical trials in all EU Member States (Figure 1). It … Continued

https://www.certara.com/blog/ctis-europe-new-clinical-trial-information-system/
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