Eligibility Review
Minimizing Failure Rates with Centralized Eligibility Review
Neuroscience trials are among the most complex and failure-prone, often producing ambiguous results—even for promising compounds. Ensuring suitable subject enrollment is essential to reduce noise, protect study investments, and increase the likelihood of clear, interpretable outcomes.
Confirming Participant Eligibility Prior to Randomization
With deep expertise in eligibility adjudication, the Lotus team ensures a comprehensive and cost-effective screening process that optimizes participant selection. Our collaborative model actively engages sites in evaluating participant eligibility, fostering site investment, and alignment with study goals.
A Structured Tiered Review Model
With deep expertise in eligibility adjudication, the Lotus team ensures a comprehensive and cost-effective screening process that optimizes participant selection. Our collaborative model actively engages sites in evaluating participant eligibility, fostering site investment, and alignment with study goals.
1
Tier 1 Review is conducted within 48 hours of receipt of a complete screening package. This includes a review of assessments, psychiatric and demographic history, and concomitant medications. An optional third-party review may be utilized for additional oversight.
2
If eligibility is clear, Medical Monitors from Lotus and Sponsor review and confirm suitability for enrollment.
3
If uncertainties arise, the case is escalated to a Tier 2 Review, conducted within 72 hours via an adjudication meeting with clinical experts and Medical Monitors to reach a final decision.
In collaboration with the sponsor, a Pre-Baseline Review Form is developed to guide the evaluation, ensuring all relevant clinical and historical data are included for a holistic assessment of participant eligibility.
This process ensures that only appropriate, assessable, and diagnostically consistent participants—whose symptoms meet study criteria and are not confounded by situational or environmental factors—are approved for randomization.
