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Clinical Research / Monitoring

Globalised Drug Development: Discover in China, Prove in Australia, Validate in Europe?

For those of us who have spent decades in clinical operations, the globalisation of drug development isn't an abstract geopolitical trend, it's a fundamental shift in how we plan, execute,...

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Clinical Research / Monitoring

Why Spain Continues as a Leading Destination for EU Clinical Trials: Advanced Clinical Delivery Team, Insights

Reflecting on over four decades in Clinical Research, I have seen the ‘go-to’ countries, regulations, complexity of study design, number of endpoints and technology change study conduct...

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Clinical Project Management

Scaling Lean: A Clinical Operations Executive's Perspective on the Biotech Imperative

Recently, I attended the 2026 PCMG meeting, where I had the opportunity to hear Petra Van Vlierberghe of argenx share invaluable insights on scaling and innovation in clinical development....

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Quality & Validation

Driving Manufacturing, Quality and Regulatory Excellence

As global demand for GMP manufacturing capacity has grown, the life sciences industry has experienced a significant wave of construction, expansion, and operational scale-up across...

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Clinical Research / Monitoring

FSP vs Full‑Service CRO Outsourcing — Choosing the Right Model for Your Clinical Program
By Kelly Costin, Program Manager on February 26, 2026

Outsourcing has become an essential part of modern clinical development, but not all outsourcing models serve the same purpose. As pipelines diversify and trial designs grow more complex,...

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Clinical Research / Monitoring Clinical Staffing

The Strategic Advantages of the FSP Model — Why Sponsors Are Embracing It
By Kelly Costin, Program Manager on February 19, 2026

As clinical development becomes more demanding, Sponsors are under pressure to deliver high‑quality studies with greater speed, precision, and efficiency. The Functional Service Provider...

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