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Indication assessment and Phase 3 clinical trial design

Screenshot 2026-10-09 173747

Industry

Pharmaceutical

The client

A pharmaceutical company preparing to take a novel asset with broad indication potential into Phase 3. The client's internal team had already narrowed the field to two primary opportunity areas and wanted outside support to pressure-test those options before committing to a trial design.

The challenge

The client needed near-term guidance on how to proceed with Phase 3 trial design, including indication sequencing and the specific design parameters that would maximize both speed to market and probability of success.

The solution

BCE worked with the client to build a custom framework for evaluating and prioritizing each opportunity area, then moved into primary research with physicians, principal investigators, competitors, and regulatory stakeholders. The research covered unmet need, standard of care, competitive path to market, trial requirements, and pricing potential. It fed two core analyses: a market model projecting adoption rate, five-year market size, and revenue timing by opportunity area, and an assessment of where clinical need and customer receptivity gave the Phase 3 trial the best chance of success.

The results

BCE developed Phase 3 trial design recommendations for two distinct scenarios. The first prioritized probability of success and speed to market, giving the client an earlier entry point and a faster path to revenue. The second was designed to maximize premium pricing potential and expand the asset's addressable market. The client pursued the faster time to market approach and has since been acquired.

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