Highline Sciences
A specialized, oncology-focused contract research organization (CRO) and consultancy providing full-service and functional clinical development support for small- to mid-market biotech companies, including trial design and execution across Phases I–III, safety surveillance, data management, regulatory and quality oversight, and staff augmentation. The organization emphasizes early-phase and oncology expertise and offers centralized clinical systems and EDC/safety database services.
Industries
Nr. of Employees
small (1-50)
Highline Sciences
San Francisco, California, United States, North America
Products
Medrio
An electronic data capture (EDC) system preferred for its flexibility and ease of use, particularly suited for complex oncology clinical trials, providing data visibility and reporting capabilities.
Medidata RAVE
A preferred electronic data capture (EDC) system known for flexibility in design and ease of use for site staff, enabling readily visible data for reporting and analysis throughout clinical trials.
Veeva Vault eTMF and CTMS
A system that integrates processes and streamlines studies from site activation through close-out within one system, increasing visibility, quality, and efficiency throughout the study lifecycle.
Oracle Argus Safety
An industry-leading adverse event management system used for centralized safety data management, configurable for single or multiple studies and compounds, offering cost savings and improved safety oversight.
Medrio
An electronic data capture (EDC) system preferred for its flexibility and ease of use, particularly suited for complex oncology clinical trials, providing data visibility and reporting capabilities.
Medidata RAVE
A preferred electronic data capture (EDC) system known for flexibility in design and ease of use for site staff, enabling readily visible data for reporting and analysis throughout clinical trials.
Veeva Vault eTMF and CTMS
A system that integrates processes and streamlines studies from site activation through close-out within one system, increasing visibility, quality, and efficiency throughout the study lifecycle.
Oracle Argus Safety
An industry-leading adverse event management system used for centralized safety data management, configurable for single or multiple studies and compounds, offering cost savings and improved safety oversight.
Services
End-to-end clinical program and study management across Phases I–III including trial design, clinical monitoring, site management, data and safety oversight.
Feasibility, site identification and selection, regulatory packet preparation, ICF negotiations, contracts and budgets, central IRB submission and eTMF/CTMS setup for site activation.
CRF design, EDC database build and validation, query management, reporting and vendor data integration to support data quality and interim analyses.
Adverse event management and global expedited reporting, safety database implementation and centralized safety oversight.
Quality oversight, inspection preparedness, risk-based audits, CAPA and training management to ensure GxP compliance.
Provision of part-time, full-time or interim clinical experts and specialized consulting for early-stage and established companies to support program planning and execution.
End-to-end clinical program and study management across Phases I–III including trial design, clinical monitoring, site management, data and safety oversight.
Feasibility, site identification and selection, regulatory packet preparation, ICF negotiations, contracts and budgets, central IRB submission and eTMF/CTMS setup for site activation.
CRF design, EDC database build and validation, query management, reporting and vendor data integration to support data quality and interim analyses.
Adverse event management and global expedited reporting, safety database implementation and centralized safety oversight.
Quality oversight, inspection preparedness, risk-based audits, CAPA and training management to ensure GxP compliance.
Provision of part-time, full-time or interim clinical experts and specialized consulting for early-stage and established companies to support program planning and execution.
Expertise Areas
- Oncology clinical trial management
- Early-phase development (first-in-human, dose escalation/expansion)
- Adaptive and modern trial designs (basket, umbrella, adaptive)
- Pharmacovigilance and safety surveillance
Key Technologies
- Electronic data capture (EDC) systems
- eTMF and CTMS
- Centralized safety database systems
- Biostatistical analysis and interim analysis methods