March 25, 2021

Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practice

Intelligent automation of pharmacovigilance (PV) tasks holds significant potential to automate manual work associated with the processing and evaluation of reported adverse reactions, thereby facilitating higher quality and more efficient risk mitigation. However, while these technologies provide great hope for vastly improving pharmacovigilance processes for both sponsors and patients, existing ways of validating technology will…

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March 11, 2021

How Shionogi and Bristol-Myers Squibb leverage data sharing to make data-driven decisions on compounds

This is the second article in a five-part blog series about TransCelerate’s data sharing initiatives. Future topics in this series will include our work on data sharing to support a robust response to COVID-19, patient privacy, and historical trial data sharing, among others. The value chain of developing new medicines to treat complex diseases in…

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March 5, 2021

Nimbleness and Innovation Are Top Themes at SCOPE 2021

While this year’s virtual Summit for Clinical Ops Executives (SCOPE) didn’t have the Floridian sun and everyone under the same roof, the conference still provided three days of jam-packed sessions featuring insights across the R&D ecosystem. TransCelerate had 10 sessions at 2021’s SCOPE, ranging from clinical R&D through pharmacovigilance. Read on for a summary of…

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