Asia’s clinical research revolution: Why the world’s innovation centre is shifting east
The global map of clinical research is changing rapidly. Once viewed primarily as an attractive destination for cost-efficient clinical trials,…
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Reaching maturity: A roadmap for Quality Excellence amid regulatory transformation
The regulatory landscape across life sciences has faced unprecedented shifts over the past year. Simultaneous realignments of FDA, EU, and…
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Why your manufacturing floor is your greatest compliance risk – and opportunity
Ask any life sciences quality leader where their biggest compliance headaches originate, and you might expect them to point to…
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Commercialising drugs in Europe: Lean models for first-time launchers
In 2025, 193 innovative drugs received approval in Europe, including 133 new molecular entities (NMEs). Over half – 56% -…
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China-ready by design: Leveraging NMPA’s new 30‑working day IND pathway
Over the last decade, China has become a key destination for oncology clinical trials, with Chinese sites increasingly incorporated within…
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Industry partnership will determine the success of the transition to low-GWP pMDIs
Opinion by Darren Bromley-Davenport, Technical Manager at Orbia Fluor & Energy Materials A tightening regulatory landscape is driving the pharmaceutical…
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From friction to compliance: Cultivating seamless operations in a shifting regulatory landscape
2026 has brought a plethora of converging technological change and regulatory updates to the life sciences industry at an unprecedented…
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Central, local, or hybrid? Designing smarter depot strategies for clinical trials
The design of depot strategy has long been framed as a fundamental trade-off within the clinical trial supply chain. Sponsors…
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Five considerations for adopting AI in clinical study build workflows
Artificial intelligence (AI) is becoming widely adopted in clinical data management, but the most persuasive use cases are rarely the…
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Biomarkers in Nephrology Research: From Exploratory to Decision-Making Tools
While strategic use of biomarkers in clinical trials has traditionally been associated with oncology, the potential for growth across other…