Protocol design is the blueprint of a clinical trial, dictating not only the scientific rigor but also the operational feasibility of the study. While its primary purpose is to ensure the integrity and validity of clinical data, the protocol also profoundly influences downstream activities such as site selection, site activation, recruitment, retention, and ultimately, the overall timelines and enrollment rates. A well-designed protocol can streamline execution, while a poorly optimized one can introduce friction at every stage, delaying outcomes and increasing costs.
In today’s environment, where timelines are compressed and complexity is rising, the ability to make data-driven protocol decisions is mission critical.
The Protocol: Strategic by Design
Protocol design is rife with operational implications. A single exclusion criterion can drastically reduce eligible participants. A poorly timed visit can increase site burden and participant dropout. And each post-draft amendment means rework, retraining, and significant delay and cost.
Yet many decisions are made without access to meaningful data. WCG is changing that.
From Static Documents to Dynamic Intelligence
Harnessing de-identified insights from over 80,000 complete protocols and 40,000 operational performance-benchmarked trials, WCG offers visibility into what works and what doesn’t.
We leverage our proprietary datasets and AI to:
- Identify potential enrollment or feasibility risks.
- Simulate operational outcomes, such as cycle times and enrollment rates, before sites are activated.
- Optimize protocols for lower burden on participants and sites.
- Reduce amendments and streamline site selection and activation.
Protocol Intelligence in Action
Our clients see a difference. In early pilots, AI-informed site lists have helped improve site performance by over 50%. Lower participant burden is directly correlated with lower enrollment rate, the impact varying by indication. And predictive models are giving teams the confidence to move forward – or pause – based on predicted operational impact.
Design Smarter, Start Stronger
Smarter, faster, and more inclusive trials start with smarter protocol and operational performance data. In a landscape where cost, time, and complexity are under constant pressure, sponsors have opportunity to leverage this data to design smarter protocols from day 1, before operational issues and costly amendments arise.
Enhance your intuition and guide better decisions.
Schedule a consultation to accelerate your clinical research based on trusted data and insights.