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.
New Updates to the FDA’s PAI Process Put Drug Developers on Notice
With the new CPMG Objective 4, the FDA has officially put knowledge management and QRM on the menu for PAI audits. So what does that mean for drug development programs?
Interview: Mike Stapleton Outlines His Vision for the Next Frontier of Digital Drug Development
A distinguished life science leader with more than 30 years of experience, Mike brings a wealth of expertise and a track record of success to his new board leadership role.
Three Ways Smart Content Authoring Accelerates CMC Workflows
Still struggling to hand-build regulatory submissions, cobble together tech transfers, and manually manage organizational knowledge? Find out how QbDVision’s latest Digital CMC tool transforms each of these time-consuming steps.
Six Trends That Will Define Digital Drug Development in 2024
New innovation, more challenges, and even bigger pressures: Here’s where digital drug development is headed next, from AI, to quality management, to nurturing digital culture, and beyond.
Drug Development’s Digital Leaders Reunite at the 2nd Annual Digital CMC Summit
For the second year in a row, technology innovators from across the life sciences flocked to Austin, TX, for this exclusive, one-of-a-kind conference experience. Stream all 9 sessions to see how drug development’s high-performance future is taking shape.
Interview With Peter Knauer, VP CMC: QbDVision Brings Digital CMC to Xeris Biopharma
A longtime customer and transformation advocate shares how QbDVision has helped his team streamline multiple key CMC workflows – including supplier risk management, post-approval change management, and tech transfer.
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.
How Our Partners at AWS Keep Drug Development Data Safe in the Cloud
Questions about security and compliance continue to hold many drug developers back from adopting cloud-based solutions. Our CTO Ryan Shillington sat down with AWS solution architect Reef D’Souza to talk about some of their most common concerns.
Tech Transfers 3X Faster: How QbDVision Made it Possible
A major regional pharma company was struggling to get multiple CMC workflows off the critical path and implement “Right-First-Time” development practices. QbDVision brought them the solution they needed to achieve their transformation goals.
