It’s a safe bet that most people’s first introduction to CDISC standards is through the Study Data Tabulation Model (SDTM). This is a content standard that ensures clinical data is submitted in a ...

EDETEK today announced the launch of a sponsor partnership program designed to help life sciences organizations prepare for and participate in the FDA's Real-Time Clinical Trials (RTCT) initiative, ...

FDA’s draft guidance on the validation of non-animal methods (NAMs) is reshaping how nonclinical programs are designed and justified. This webinar explores how sponsors can apply NAMs to streamline ...

尽管经过十年的投入与监管层面的积极推动，由真实世界数据（RWD）产生的真实世界证据（RWE）在药物审批中的应用仍然不足。除却相关且可靠的RWD这一基本需求外，三个相互关联的操作性障碍 ...

As clinical trials grow increasingly complex and multi-modal, the pharmaceutical industry is pivoting toward AI-driven agentic orchestrators and lakehouse architectures to untangle disparate data ...

Artificial intelligence is rapidly becoming embedded across the biopharmaceutical R&D continuum—from early discovery and preclinical decision‑making to clinical development and regulatory review. Last ...

2026 年初，CDISC（Clinical Data Interchange Standards Consortium）发布了 SEND Implementation Guide v4.0（SENDIG 4.0）草案[1]，面向全行业征求意见（截止日期为 2026 年 4 月 6 日）。该草案旨在为非临床数据标准化 ...

The Central Drugs Standard Control Organization (CDSCO) has simplified the processing of applications to export active substances to the European Union. Under EU law, active pharmaceutical ingredients ...

FDA（米国食品医薬品局）へ新薬承認申請（NDA）や生物製剤承認申請（BLA）を行う際、臨床試験や非臨床試験の電子データを提出する必要があります。 現在の基準ではCDISC標準（SDTM、ADaM、SEND ...

The US Food and Drug Administration (FDA) has reissued guidance aimed to enhance the enrollment and retention of females in clinical trials and non-interventional studies, removing references to ...