Therapeutic expertise

Two companies merging, each with complete sets of established SOPs. Both teams had strong loyalties to their existing processes, and integration needed to happen quickly without disrupting ongoing operations.

I performed a comprehensive GAP analysis comparing both SOP sets, identifying overlaps, conflicts, and best practices from each organization. Then I consolidated and recreated a unified system that honored the strengths of both approaches while simplifying for clarity. Throughout the process, I facilitated stakeholder meetings to build consensus and ensure buy-in from both teams.

Successfully integrated both organizations into a streamlined, compliant system. Both teams embraced the new processes, and the merger proceeded without operational disruption.

One year into an active study, the company had not properly managed protocol deviations—creating significant compliance risk and threatening the integrity of the trial data.

I systematically reviewed data listings, monitoring trip reports, and partial PD logs to create a comprehensive deviation tracker. Then I established cross-functional review meetings to properly categorize deviations, escalate issues for CAPA, and implement corrective training. I created a Protocol Deviation Management Plan that clearly outlined reporting procedures, responsibilities, and escalation paths—then implemented monthly oversight meetings to ensure sustained compliance.

Brought the study back into full compliance with a sustainable management system in place. The clinical team was properly trained on deviation identification and documentation, and the program remained compliant through study completion.

The relationship between Sponsor and CRO had completely broken down. Distrust was pervasive, blame was being passed between parties, and study completion was at risk.

I reviewed contract commitments and SOPs for both parties to identify where breakdowns had occurred. I documented specific instances where service delivery or communication fell short of contractual obligations—then facilitated structured meetings with key stakeholders to rebuild functional working relationships. We established new communication protocols, clarified service level expectations, and negotiated appropriate budget adjustments to reset the partnership on solid footing.

While the partnership remained professional rather than warm, we successfully established functional working relationships that allowed study completion on schedule. Both parties met their obligations and delivered quality results.