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Reg 2
Regulatory V8 I3

Medical Management in Clinical Trials: A Roadmap to Operational Excellence (Part 2 – Study Setup)

The more robustly and transparently the medical procedures are defined and documented, the more streamlined it gets during the study conduct and close-out phases. Further, …

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Reg 1
Regulatory V8 I3

Demand for Data Puts Safety at Centre in Decision-making

Where once pharmacovigilance was regarded as a necessary burden, pharmaceutical companies are starting to recognise that safety in fact plays an integral role in business …

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01. Device Integration in Clinical...
Regulatory V8 I3

Empowering Real-world Evidence Analysis Through Riskbased De-identification

Clinical trials produce vast amounts of incredibly valuable data that, outside the initial research objectives, is not being sufficiently leveraged, according to Pamela Neely Buffone, …

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