SITUATION
A global pharmaceutical company was preparing for a Phase III clinical trial for its new immunology treatment. The therapy had shown promise in earlier stages, and the company was under pressure to meet accelerated approval timelines without compromising trial quality or compliance.
The internal team wanted to refine the trial design, reduce delays in site activation, and ensure the protocol aligned with regulatory expectations across key markets, including the US, EU, and APAC regions.
CHALLENGE
The company lacked updated visibility into how competitors were structuring similar trials globally. Their protocol development relied mostly on internal experience, general guidelines, and retrospective assumptions.
Specific challenges included:
- Uncertainty around trial duration and typical dropout rates in similar populations
- Lack of real-world data on regional enrollment performance
- Limited knowledge of protocol amendments made in competitor trials
- High resource costs tied to protocol redesigns and slow site onboarding
These factors increased the risk of avoidable delays and regulatory feedback.
APPROACH
ConsaInsights was brought in to deliver a structured benchmarking analysis of global competitor trials. The goal was to support the company’s clinical strategy team with actionable data and reduce the time spent on protocol rework.
Competitor Trial Benchmarking
We identified and analysed over 25 Phase III trials in immunology conducted in the past five years. Data points included trial length, inclusion/exclusion criteria, endpoint structure, site counts by region, and amendment frequencies. This was mapped against regulatory approvals to highlight patterns of success.
Country-Level Performance Modelling
Using clinical trial registry data, investigator networks, and recruitment metrics, we built a country-specific performance matrix. This helped the client prioritise geographies with high enrollment speed and lower dropout risks.
Protocol Efficiency Recommendations
We provided evidence-backed recommendations to adjust endpoint definitions, reduce unnecessary inclusion criteria, and optimize site selection. All inputs were mapped against the client’s existing draft protocol for easy alignment.
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Business Impact
Working with ConsaInsights brought a new level of clarity and precision to our Phase III trial planning. Their competitor benchmarking not only saved us weeks of protocol rework but also helped us avoid costly delays during site activation. The insights were actionable, region-specific, and directly aligned with regulatory expectations.
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