Full-Spectrum Clinical Research Capabilities
Expert support across the entire human study lifecycle, from regulatory approval to sample collection and analysis.
Services
Institutional Review Board applications
- Research of primary literature and other data sources
- Document development and approval
Serial blood draws
- Intravenous catheter and venipuncture
- Blood processing/plasma collection
Stool collection (microbiome analysis)
- Specialized subject training and collection kit provision
- Immediate freezing and cold chain management (e.g., dry ice)
- Coordination for specialized microbiome sequencing and analysis labs
Pharmacokinetic (PK) analysis
- Methodology consultation for sampling schedules and matrix selection
- Non-compartmental analysis (NCA) of concentration-time data
- Interpretation and reporting of key PK parameters
Investigational New Drug applications
- Research of primary literature and other data sources
- Document development
- IND maintenance and reporting
Urine collection
- Compliance with specimen integrity and temperature requirements
- Aliquot preparation and secure storage
ClinicalTrials.gov data entry and maintenance
- Initial registration of study protocol and consent documentation
- Ongoing maintenance and tracking of recruitment status
- Mandatory reporting of summary results and adverse events