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Early phase trials need risk-based quality management too

We had a really interesting (and refreshing) conversation with a small, West Coast Biotech this week. Often early stage Biotech’s tell us “We don’t really need to do RBQM because it’s early phase and small patient numbers”. The team we spoke to this week had completely the opposite view. Their approach was “If there was ever a time to manage risk, it’s at the start when the drug is first administered in human , right?” and “I don’t recall the part of E6 (R2) where it says ‘you should do risk based quality management - but you don’t need to don’t bother in early phase trials’”.

The other piece that made this team stand out was their understanding of the benefits that RBQM can bring to a pipeline of drugs. Being able to compare trends, risks and impacts of similar compounds across different therapeutic areas has the potential to bring rapid and obvious benefits to both the efficacy of the trials and patient safety. Being able to demonstrate and report clearly the assessments, decisions and actions taken right from the start of Phase 1 will better inform later study phases and demonstrate a framework of compliance and quality management right from the start of the clinical phase.

Anything which increases the chance of a drug making it to market is a good thing for all concerned, especially those people suffering from the conditions we're trying to treat.


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