Clinical Operations Consulting Services
Expert guidance to optimize your clinical research and operations
KEN HARPER CONSULTING LLC provides specialized consulting services to enhance your clinical operations, streamline trial processes, and ensure regulatory compliance. With extensive industry experience, we deliver strategic solutions tailored to your organization's specific needs.
Industry Expertise
Leveraging decades of combined experience in clinical operations and research
Customized Solutions
Tailored consulting strategies designed to address your specific operational challenges
Ongoing Support
Comprehensive guidance and responsive communication throughout your project
Our Services
Comprehensive solutions for your business needs
Clinical Trial Management
Strategic guidance for optimizing clinical trial processes, from protocol development to study closeout, ensuring efficient operations and regulatory compliance.
• Protocol Development & Review
• Study Startup Optimization
• Site Selection & Management
• Regulatory Submission Support
Quality Assurance & Compliance
Comprehensive services to ensure your clinical operations meet all regulatory requirements and industry standards, minimizing risk and maintaining data integrity.
• GCP Compliance Assessment
• SOP Development & Implementation
• Audit Preparation & Management
• CAPA Planning & Execution
Operational Excellence
Performance optimization solutions to enhance your clinical research operations, improve efficiency, and accelerate study timelines while maintaining quality standards.
• Process Optimization
• Resource Planning & Allocation
• Vendor Management & Oversight
• Performance Metrics & Analytics
Consulting Service Options
Flexible engagement models tailored to your specific project needs
Free
• Needs Evaluation
• Strategic Recommendations
• Service Overview
• Project Planning Discussion
Custom
• Comprehensive Project Strategy
• Regular Progress Updates
• Implementation Support
• Process Documentation
• Training & Knowledge Transfer
Custom
• Ongoing Strategic Guidance
• Continuous Process Improvement
• Regulatory Advisory Services
• Team Training & Development
• Ad-hoc Operational Support