The start-up phase of a clinical trial should be a launchpad. Instead, it's too often a bottleneck slowing timelines, frustrating sites, and burning valuable momentum before a single patient is enrolled.
The issue isn’t effort. Every stakeholder involved - sponsors, CROs, and especially sites - is committed. But the current model strains under its own complexity.
And the people closest to the work? They’re the ones paying for it.
Start-Up Complexity Isn’t New But It Is Escalating
Over the past decade, trial designs have grown more ambitious. That’s good for science, but it comes with a cost: more protocol amendments, increased site burden, longer negotiations, and an administrative load that can cripple smaller or resource-strained research centers.
In WCG’s recent site-focused report, trial complexity emerged as the top challenge for nearly 40% of respondents. No surprise there. Complexity slows everything from feasibility reviews to contracting, budget alignment, and IRB approvals. And the longer these timelines stretch, the harder it becomes to hold site engagement and resource availability.
Why This Matters More Than Ever
The clinical research landscape is increasingly competitive, and speed is strategy. But it must be smart speed.
Pushing for faster activation without solving structural issues only shifts pressure onto sites already at capacity. The result? Delays. Drop-offs. And growing reluctance from research centers to take on new studies. Not because they lack motivation, but because the process is broken.
We’re not dealing with unwilling partners. We’re dealing with an overwhelmed frontline.
The Path Forward? Collaborate Better. Simplify Wisely. Align Early.
This isn’t about grand reinventions. It’s about practical, scalable change; the steps we can take today to meaningfully reduce friction and help sites succeed.
1. Co-Design, Don’t Just Delegate
Bring experienced sites into protocol development earlier. Let them highlight what’s workable, what’s risky, and where support will be needed. Operational feasibility is not an afterthought. it’s a prerequisite for success.
2. Streamline the Start-Up Stack
From feasibility to SIV (Site Initiation Visit), the process is riddled with redundancies. Sponsors and CROs need to simplify where possible - shorter surveys, standardized budgets, pre-negotiated contracts. Every hour saved upstream matters downstream.
3. Invest in Site Enablement
It’s not enough to hand over a protocol and expect flawless execution. Provide onboarding support, access to centralized tools, and responsive communication channels.
Treat sites as strategic partners, not administrative endpoints.
4. Create Visibility Through Shared Metrics
Too often, misalignment stems from lack of clarity. Use shared dashboards to track startup milestones, identify delays in real-time, and collaborate on solutions; before the impact cascades.
Progress Is Possible If We Prioritize the Right Things
Improving trial start-up isn’t about chasing perfection. It’s about making it easier for sites to deliver great research. That means empathy, clarity, and operational discipline from all sides.
Clinical research sites are not the problem. They’re actually the key to getting this right. And when we design systems that reflect that reality, the entire ecosystem benefits.
One Step Forward Beats Standing Still
There’s no silver bullet. But there is a path that starts with better collaboration, realistic timelines, and mutual accountability. When sponsors and CROs align their systems with site needs, everyone moves faster.
Let’s stop waiting for ideal conditions. Let’s start building smarter ones.
Because every day we save in start-up is a day closer to new treatments reaching patients - and that’s the outcome we’re all here for.
