Integrated CRO + Site Execution in Bunionectomy Pain Research

Lotus served as the CRO while ERG contributed 7 of 8 study sites in a Phase 2b trial of an investigational non-opioid product candidate.

Randomized, double-blind, placebo-controlled Phase 2b bunionectomy trial.
Two active dose groups vs. placebo; 450 subjects randomized across 8 U.S. sites.
72-hour domiciled observation with tightly timed pain assessments and rescue medication control.

430/450

Subjects enrolled by ERG

Of total enrollment delivered by ERG

Study sites were ERG sites

The Challenge

Protect assay sensitivity in an acute pain model with subjective endpoints and placebo-response risk.
Execute standardized surgery/anesthesia, time-sensitive postoperative assessments, and strict rescue medication procedures.
Maintain consistency across sites during intensive 72-hour post-surgical follow-up.

The Lotus ERG Approach

Integrated CRO + site model with ERG providing 7 of 8 sites: Pacific Research Network, Clinical Pharmacology of Miami, Midwest Clinical Research Center, First Surgical Hospital, Legent Orthopedic Hospital,
Memorial Hermann Village, and Endeavor Clinical Trials.
Lotus PRM was essential to study execution reinforcing consistent conduct and assessment, protecting assay sensitivity, and reducing avoidable placebo-related variability.

ERG enrolled 430 of 450 subjects (95.6% of total enrollment) across 7 study sites.

ERG’s mission is to provide the highest quality clinical trial execution across all clinical research phases to help sponsors.