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Preparing for ICH E6(R3): Understanding the 11 Core GCP Principles
Explore the 11 GCP principles outlined in ICH E6(R3).
February 23, 2026
Exploring Multiple Perspectives in Rare Disease Trials
What makes rare disease trials unique? Explore perspectives across functions from a rare disease CRO team.
February 16, 2026
Database Build: Our Standard Timeline from Final Protocol to Database Go-Live
How long does it take to go from final protocol to database go-live?
February 9, 2026
Examining Strategies for Faster Clinical Study Report Timelines
Examining Strategies for Faster Clinical Study Report Timelines How long does it take a medical writer to produce a high-quality clinical study report (CSR)? What can a medical writer do to help speed up this turnaround without sacrificing quality? Biopharma companies are under increased pressure to reduce timelines, yet this acceleration cannot come at the...
February 2, 2026
Operationalizing ICH E6(R3) and QbD with a Quality Assurance Consultant
How can a QA consultant help your team fully adopt QbD?
December 18, 2025
Evaluating Quality Culture in Clinical Research
Evaluating Quality Culture in Clinical Research: Beyond the Buzzword While it’s one thing to discuss a culture of quality in clinical research, it’s much more complicated to make it a reality – embedded into the way teams think, act, and make decisions across an entire organization. This echoes timeless guidance from W. Edwards Deming, an influential...
December 12, 2025
Why Deming’s Out of the Crisis Still Shapes My Approach to Clinical Quality
QA Director Melisa Williamson talks about “Out of the Crisis” by W. Edwards Deming and how it has influenced her approach to quality.
November 21, 2025
Solving Data Management Challenges with Strategic CRO Oversight
Explore three common findings from a data management consultant who has experience performing DM CRO oversight.
November 19, 2025
CRO Study Team Continuity and Transparency
Will you actually be working with the team a CRO introduces you to in early discussions?
October 14, 2025
Case Study: Proactive Risk Mitigation in Early Phase Oncology
This case study highlights how the PharPoint team supported a Phase 1 FIH oncology study that completed LPLV and database lock ahead of schedule.
October 7, 2025