Blogs
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Realizing Business Benefit And Inspection Readiness With A Solid CAPA Framework
5/8/2024
Embracing proactive quality culture transforms CAPA from a routine task to a continuous improvement tool. Learn how senior management support and robust processes drive excellence.
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Getting The CAPA Framework Right The First Time
5/8/2024
CAPA processes, though often seen as regulatory burdens, offer significant business benefits. Implementing them requires a cultural shift and methodical approach for lasting improvement.
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Staying Ahead Of The Latest Developments And New Transparency Rules
3/15/2024
Navigating the Clinical Trials Regulation (CTR) in the EU presents challenges amid evolving guidelines. Recent updates, like transparency rule changes, aim to streamline compliance.
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Handling Substantial Modifications Under The CTR
3/15/2024
The transition of ongoing clinical trials to meet CTR requirements can be challenging. Examine some key considerations, including substantial modification processes and strategic dossier updates.
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CTR In Focus: Strategic Planning To Transition To The EU Clinical Trials Regulation
3/15/2024
As the EU clinical trials transition deadline approaches, companies must strategize to move trials to the new framework efficiently. Key steps and considerations are crucial.
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Building A Strong Sponsor-CRO Relationship For An Inspection-Ready TMF
6/15/2023
Get the highlights from a February 2023 FierceBiotech webinar, where pharmaceutical company Chiesi and CRO CROMSOURCE shared best practices from their decades-long partnership.