Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program Blog Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program Learn how the FDA assessment aid streamlines oncology NDA/BLA reviews, what to include, and best…Certara2026年3月17日
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FAQs on Developing EMA Policy 0070 Submissions Blog EMAポリシー0070提出書類作成に関するFAQ This blog answers audience questions posed during our RAPS webinar, How to Plan for a…Certara2025年9月15日
Best Practices for Safety Narrative Writing in Clinical Research Blog Best Practices for Safety Narrative Writing in Clinical Research Explore the patient narrative format in medical writing and why narrative writing in clinical research…Certara2025年9月5日
Regulatory Operations Best Practices for Health Canada Submissions Blog Regulatory Operations Best Practices for Health Canada Submissions Health Canada submissions now require eCTD/CESG; regulatory operations expert support can streamline the process and…Certara2025年8月11日
Everything you need to know about ILAP 2.0 White Paper ILAP 2.0 について知っておくべきことすべて This white paper share’s key insights on the relaunch of MHRA’s Innovative Licensing and Access…Certara2025年5月19日
Protect Confidential Information in Investigational Drug Submissions Blog 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
Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study Publication HIV感染でウイルス学的に抑制されている思春期患者における、長時間作用型注射剤カボテグラビルと長時間作用型注射剤リルピビリンの併用療法の安全性(IMPAACT 2017/MOCHA):第1/2相、多施設共同、オープンラベル、非比較、用量設定試験 The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…Certara2025年3月20日
EU CTIS: Europe’s New Clinical Trial Information System Blog EU CTIS: 欧州の新しい臨床試験情報システム The EU CTIS is now fully implemented, replacing EudraCT as the central hub for clinical…Certara2025年2月10日
Anonymization vs. Redaction of Clinical Trial Data Blog 臨床試験データの匿名化と編集(レダクション) 2025年1月17日 The vernacular for disclosing pharmaceutical clinical trial results to the public may…Certara2025年1月17日