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
Your Brain's Decision-Making Window: Why Timing Beats Willpower
You're 20 minutes away from your one-to-one with your PD/VP.
Your list of topics is enormous: the sponsor pushing back on timelines, the vendor underperforming, the budget that needs defending, three strategic decisions that can't wait. You need to prioritise, you need to think clearly … but you feel exhausted.
It's 4pm. Your brain feels foggy. The decisions seem harder than they should be. That's not a coincidence.
Your prefrontal cortex uses 20% of your body's glucose despite being only 4-5% of your brain's size. By afternoon, you're running on depleted cognitive resources. Every decision you've made since waking has drained your mental battery.
Most PMs and PDs waste their cognitive prime time on emails and routine tasks, then attempt their hardest decisions when their brain is least capable. This post reveals the neuroscience behind decision fatigue and how to identify your personal peak performance window.
Brain-Based Strategies (5/7)
Understanding your Sponsor's journey intellectually is one thing. Translating that knowledge into empathetic, strategic behavior under pressure is entirely another.
When your Sponsor pushes back on budget for the third time, when they request another urgent status call, when they resist a sensible protocol change, your brain's default stress response can override everything you know intellectually.
This post shares neuroscience-backed strategies that work with your brain, not against it, to help you maintain strategic partnership perspective even when pressure is high.
These aren't just mindset tips. They're practical cognitive tools that transform how you show up when it matters most.
The Disconnect (4/7)
There's a profound disconnect between what Sponsors experience and what CRO PMs see. Sponsors carry years of investment, stakeholder pressure, and career stakes. CRO PMs receive an RFP with a two-week deadline and operational requirements.
This gap creates misunderstandings that damage partnerships.
When you bridge this disconnect and see your projects through your Sponsor's eyes, everything changes. You transform from a vendor executing tasks to a strategic partner protecting their investment.
The Go/No-Go Decision (3/7)
The Go/No-Go decision for Phase I isn't a formality. It's a high-stakes boardroom moment where leadership decides whether to commit millions to moving forward. They evaluate ten critical factors: scientific rationale, competitive landscape, commercial potential, regulatory pathway, manufacturing readiness, financial capacity, organisational capability, partnership strategy, risk tolerance, and strategic fit.
When you understand what's at stake in this decision, you'll never again see Phase I as "just a small pilot study." You'll recognise it for what it truly is: a major strategic commitment that can define careers, validate acquisitions, and determine whether a company survives or thrives.
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.
Understanding What Happens Before the RFP Lands on Your Desk (1/7)
Why do Sponsors push back so hard on budget? Why do timeline delays trigger urgent calls? Why do they resist simple protocol amendments?
The answers aren’t what you think.
When you understand the years of work, millions invested, and career-defining pressure behind every RFP, frustrating behaviours transform into partnership opportunities.
This perspective shift, from seeing budget consciousness as cheapness to recognising it as financial stewardship of massive investment, separates transactional PMs from strategic partners who win more work and deliver with excellence and empathy.
If you've ever wondered what really drives your Sponsor's decisions, this is where understanding begins.