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risk sharing
Regulatory V6 I2

Risk-sharing: Supplementing Clinical Trials for Payer and HTA Success

As the benefits of real-world data become more apparent, so too, do issues around its appropriate collection methodology and reliability. Olivier Ethgen of SERFAN Innovation …

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Editorial Archive

Is Risk-based Monitoring an Appropriate Methodology for Clinical Trials in Emerging Regions?

When it comes to emerging regions – where sites and monitors generally have less experience in clinical research than those in North America and Western …

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regulatory
Editorial Archive

Regulatory Framework for Developing Clinical Trials in Romania

The measure of Romania’s success as a clinical trials destination lies in the rapid evolution of the regulatory framework, which was promptly transposed from EU …

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bioequivalence
Editorial Archive

Prospects of Conducting Bioavailability/Bioequivalence (BA/BE) Studies and Outsourcing in Semi-regulated Countries

Given the rapid progress of the global generics drug market, organisations must critically manage and assess bioequivalence studies that are mandatory when bringing new generic …

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