Remote consulting services for Biotech, Pharma, and CROs
📧 stephanie@apoeaconsulting.com
APOEA offers 15 years of experience in project and quality management. Our certified Clinical Project Manager and Quality Manager with 15+ years of experience supporting biotech, pharmaceutical, and CRO teams. Through APOEA Consulting, I deliver remote, high-impact solutions in clinical operations, quality oversight, and strategic project execution.
Our services include TMF QC, SOP development, CTMS setup, KPI dashboards, audit readiness, and stakeholder reporting—tailored to help sponsors and research teams stay compliant, efficient, and inspection-ready.
APOEA Consulting delivers strategic, compliant, and technology-enabled services designed to support biotech, pharmaceutical, and CRO organizations at every stage of the clinical trial lifecycle—fully remote, highly experienced, and results-driven.
• Trial Master File (TMF) setup, QC, and inspection readiness
• CTMS configuration and oversight
• Study startup coordination and regulatory documentation
• Budget negotiation and contract reconciliation
• Strategic planning and milestone tracking
• KPI dashboard creation and performance reporting
• Risk mitigation and contingency planning
• Stakeholder communication and reporting frameworks
• Internal audits and SOP gap analysis
• Quality Management System (QMS) implementation
• CAPA tracking and resolution
• UAT testing and database validation
• Site staff onboarding and protocol training
• SOP rollout and change management
• TMF and CTMS user training
• Development of onboarding materials and learning modules
• Source data abstraction and verification
• Invoice creation, approval workflows, and sponsor communications
• Document QC and archival compliance
• Enrollment strategy and contingency planning
• Sustainability tracking and carbon footprint reduction
• Process optimization and operational redesign
• EHR and EDC system optimization (Epic, Allscripts, RAVE, Oracle)
• SharePoint and Smartsheet setup for collaboration
• Dashboard development and automation flows

APOEA Consulting brought immediate structure and clarity to our clinical operations. Their expertise in TMF quality and CTMS optimization significantly improved our audit readiness and team efficiency

Stephanie’s strategic approach to project management and compliance helped us mitigate risk while staying on schedule. Her ability to work seamlessly with cross-functional teams made a measurable impact on our study outcomes

Patient
From SOP development to technology integration, APOEA Consulting delivered high-quality, practical solutions tailored to our organization. The remote delivery model was efficient, responsive, and highly effective.