Data Governance and Integrity: Pharma, Biotech, and the Data Deluge, Part 4
In chapter 4 of our series on drug development data, Yash looks at a practical application of structured data principles: building a digital qTPP that supports automation of numerous CMC tasks.
Data Governance and Integrity: Pharma, Biotech, and the Data Deluge, Part 3
Scrambling to consolidate CMC data often feels like a rite of passage for drug developers. But does it have to be that way? In post 3 of our series on data governance and integrity, Yash shares a modern, structured approach to managing CMC data.
Data Governance and Integrity: Pharma, Biotech, and the Data Deluge, Part 2
In post #2 of our data governance series, we look at the kind of information frameworks drug developers should consider as they work to fully maximize the integrity and value of their data.
Data Governance and Integrity: Pharma, Biotech, and the Data Deluge, Part 1
Today’s drug developers are deluged with unstructured data. In this first post of a new series, find out how pharma and biotech companies are struggling to manage their information resources.
Countdown to M4Q(R2): ICH Prepares For Quality’s Digital Future
Two decades ago, the ICH’s M4Q guideline provided an invaluable bridge between CTD Modules 2 and 3. Now, a timeline revision promises to accelerate the industry’s shift to digital CMC.
