A practical guide through the complete Clinical Research Project lifecycle and key Management Skills in small bytes.
These posts walk you through each stage primarily from a CRO perspective with Pharma insights where processes differ. You'll find real experiences from 25 years in the field, templates you can adapt, brain-based strategies to reduce chances of burnout, and AI prompts that actually can help you.
Where project management methodology meets neuroscience and practical AI application.
Featured Articles
The Preclinical Journey: What Must Happen Before Phase I (2/7)
Before your Sponsor can dose a single human volunteer, they must complete a rigorous gauntlet of preclinical studies that costs millions and takes years. From pharmacokinetics to multi-species toxicology, from formulation development to manufacturing scale-up, every step is governed by strict regulatory requirements.
When you understand that the IND filing represents crossing a "sacred threshold" after years of scientific validation, you'll never again wonder why Sponsors react so strongly to protocol deviations or timeline delays. This isn't just another regulatory document. It's the culmination of their entire journey and the gateway to everything they've been working toward.