Featured Insights

Learn about the Life Science Industry

Our featured insights contain all of our latest articles, columns and think pieces about issues that matter most in the life science industry today. 

 

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What is Real World Evidence (RWE) and why do we need it?

It is has been long established that it is essential to conduct randomized controlled studies as part of the drug development process. However, these “high-level evidence” studies are not always sufficient to get approval from the regulatory bodies. Often, additional evidence from so-called “Real World Evidence” studies is required. Dr Robert Szulkin explains.
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Column: You won´t find this many Concorde projects anywhere else

Nowhere else but in drug development are so many Concorde projects to be found. Why is that?

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Studiedesign: Hur många patienter behövs i en klinisk studie?

Kan vi vara mer flexibla när vi gör studiedesign? Kan man modifiera studien när den pågår och man får mer information om effektstorlek och variabilitet?
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Using Statistics to Solve the Largest Mysteries

By using biostatistics and his expertise in research methodology, Niclas' wants to find a cure for Alzheimer's disease.
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4 Crucial challenges in real-world evidence (RWE) studies

Planning and conducting a real-world evidence study can be very challenging. In this article, SDS consultant Robert Szulkin breaks down four crucial challenges when conducting an RWE study.

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Regulatory affairs considerations for drug development

Why is it so important for Life Science companies to invest in regulatory affairs activities as part of the development program for their products? What are the challenges and the key aspects for regulatory and business success?

 

 

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