About our partner

• Global Project Management
• Feasibility Assessments
• Clinical Operations Consulting - Strategic Site Selection, Impact of Inclusion/Exclusion Criteria
• Evaluation and Management of Clinical Teams and Other Vendors Including IVRS, Central Laboratories, Drug Packaging and distribution, Electronic Data Capture and Data Management, Contract Staffing and Phase I units.
• Regulatory Document Collection and Submissions to Ethics Committees and Ministries of Health Worldwide
• Clinical Site Monitoring
• Medical Monitoring and SAE Management
• Drug Import, Storage and Customs Management
• Investigator Meeting Management
• Investigator and Client Staff Training Courses in Drug Development, Clinical Research GCPs, Global Trial Conduct and Management

Our Partner Provides Comprehensive Clinical Development Services In Collaboration with Our Network of Clinical Development Partners from Preclinical Assessments to NDA Submissions Including:

• Protocol Development Phases I-IV, Including Expanded Access
• Medical Writing
• Investigational Brochures
• Clinical Study Reports
• IND Annual Safety Reports
• Preparation and Submission of INDs, CTAs and Other License Applications
• Arranging and Managing Meetings with Regulatory Authorities, Including FDA
• Evaluation of Licensing Candidates
• Case Report Form Design
• Data Management and Statistics