Conducting Early Stage Clinical Trials
R&D / INNOVATION
OUR SERVICES
STUDY DESIGN
• Deep expertise and experience in designing studies for a range of therapeutic areas
• Track record of successful, innovative study design, and regulatory interactions
• Adaptive designs with go/ no-go decision points
• Real time trial monitoring to ensure data quality, risk mitigation, and engagement of all stakeholders
DATA PACKAGE
• Cutting edge data collection, and management platform
• Dashboarding with integrated advanced data analytics and visualization
• Real time access to the study data allowing for study adaptations
• Delivery of final statistical analysis and reports
STUDY EXECUTION
• Multi-site, fully licensed clinical facilities
• State-of-the-art medical laboratory
• Staff consisting of highly qualified medical professionals, including MDs, psychiatrists and nurses
• Approximately 1000 currently active patients and healthy volunteers, and over 4000 historic patients
COMPLIANCE
• Regulatory compliant data package (ADAM/CDISC)
• HIPPA compliance
• Strict compliance with internal and client SOPs
• 21 CFR part 11