Core Competencies

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Expertise in creating trial and operational strategies to ensure rapid start up and enrollment within timelines and budget all while meeting your primary protocol objectives: 

• Clinical protocol design & writing
• Study plan strategy and design
• Operational strategy and plan development
• Vendor identification and selection

With over 13 years of DCT expertise overseeing over 200 DCT studies globally and expertise in building world class DCT and HHC divisions, first in class technology builds and trial implementation, let our DCT experts support you in building and operationalizing your DCT strategy or clinical trial. 

• Strategy and design
• Operational management and support
• Vendor identification and management
• In-house DCT training
• Quality and inspection readiness

Our experts focus on merging proven operational strategies with innovation, efficiency and speed resulting in quality by design. Let our experts support your teams in 

• Project lifecycle management
• Vendor selection, start up and management
• Monitoring services and strategies
• Risk mitigation
• Quality and inspection readiness

With extensive pharmaceutical industry experience, our experts have led 500+ clinical trials and 500 + audits resulting in successful NDA submissions, our experts know inspection readiness is critical. Planning for high quality project delivery and patient safety is imperative. Let our quality experts ensure your clinical trials are up to the 

highest standards

• Qualification audits
• Inspection readiness
• TMF audits
• PM audits
• Site audits
• Quality plan development
• Risk and issue plan development
• Mock inspections

Capitalize on proven pharmaceutical and CRO experience to expand and improve your organization with either service or geographical expansion, improved financial performance or corporate operational excellence. We can help you drive your operations to the next level of excellence and ensure improvements across all levels. 

• Corporate service expansion
• Global or regional service expansion
• Financial analysis and efficiency
• Sales strategy
• Change management
• Operational execution analysis and improvement
• SOP development
• Resource planning

Development of staff across the project life cycle to ensure highly functioning teams resulting in improved timelines, financial performance, quality and customer satisfaction is critical for any organization. Our experts have successfully developed teams and training curriculum resulting in exceptional program and project delivery. 

• Critical path identification and planning
• How to create highly functioning teams
• Remote teams
• Timeline management
• Budget management
• Vendor oversight and management
• Inspection readiness