Real-time oversight. Proactive problem-solving. Full commitment to your success.
Maieutics Clinical Oversight
Recruitment oversight
Conduct of analysis of site, territory, and country performance along with direct communication with CRAs to understand/identify potential barriers to patient recruitment.
Clinical Monitoring Oversight
Ongoing real-time oversight of CRAs, supported by on-site monitoring visits and audits, to proactively identify potential adverse issues.
CRO Oversight
Real-time tracking monitoring of objectives budget utilization, resource allocation, site geographical distribution, Quality assurance of CRO activities
Analysis and suggested improvements of Protocol and study manual
Evaluation Schedule Planning: Provide guidance on evaluation schedules to ensure they are realistic, structured, and achievable.
Analysis and suggested improvements of Budget review
Economic analysis of recruitment
-Strategic Monitoring Approach: (Risk based Monitoring vs Centralizedm monitoring)
-Feasibility Study Strategy: Evaluate the suitability of outsourcing versus insourcing models
Maieutics Outsourced Operations
Site strategic selection
Identify the most suitable sites to ensure fast recruitment, reliable data quality, and optimal budget efficiency.
Start Up activities
Handle regulatory, ethics committee and contract formalities ( Within the European region).
CRA Activities
Site visits: Qualification, Site initiation, Interim monitoring, Close-up Site management