Laboratory Services
- Protocol development
- Preparation of site manuals
- In-services at clinical sites
- Design of analysis methodology
- Software development for tailored analysis
- Design of case report forms
- Ongoing quality assurance programs for data reliability
- Validation of all systems and equipment
- Independent internal quality assurance
- Independent data analysis
- Data tracking and management that complies with FDA regulations
- Project management
- Independent internal biostatistics and report writing
- Secure data storage
- Development of new testing methodologies and software, as necessary, to fulfill trial requirements
Data Capabilities
- Clinical trial project management
- Protocol design and development
- Statistical analysis planning and execution
- Database design and SAS programming
- Paper and electronic case report form design
- Data entry and cleaning
- Clinical site selection, recruitment, and ongoing management
- Investigative site training and query resolution
- IRB/MEC communication
- Safety surveillance and medical monitoring
- Regulatory expertise and FDA representation
- Data safety monitoring boards
- Clinical events committees including dossier preparations by MDs
- Interim and final data analysis
- Interim and final report writing
- Manuscript and abstract creation for publication and presentation
