United BioSource, LLC
Provider of evidence development, patient access, and drug safety solutions for biopharmaceutical sponsors. Services include real-world evidence study design and execution, global pharmacovigilance and REMS support, patient access and site-of-care programs, a national and international clinical nursing network, and integrated technology platforms for data management, analytics, and safety reporting. The company also publishes and applies methods for designing SDOH-informed patient access programs, travel-concierge support for global trials, clinical trial diversity planning, and linkage of patient support program data with longitudinal real-world data to inform the patient journey and evidence generation.
Industries
Nr. of Employees
Very Large (1000+)
United BioSource, LLC
Products
Source-agnostic real-world evidence platform
Platform for ingesting, storing, and analyzing real-world data with privacy and regulatory controls to support evidence generation.
Pharmacovigilance reporting and analytics platform
Platform to generate aggregate PV outputs, ad-hoc reports, visualizations, and scheduled reports to support regulatory safety activities.
Clinical trial technology suite (EDC/CTMS/eTMF and integrations)
Integrated clinical trial systems to support data capture, trial management, and trial master file requirements.
Source-agnostic real-world evidence platform
Platform for ingesting, storing, and analyzing real-world data with privacy and regulatory controls to support evidence generation.
Pharmacovigilance reporting and analytics platform
Platform to generate aggregate PV outputs, ad-hoc reports, visualizations, and scheduled reports to support regulatory safety activities.
Clinical trial technology suite (EDC/CTMS/eTMF and integrations)
Integrated clinical trial systems to support data capture, trial management, and trial master file requirements.
Services
Evidence development services
Consulting and execution of observational, registry, and real-world studies to generate evidence for regulatory, payer, and clinical stakeholders.
Safety & risk management services
Pharmacovigilance operations, REMS program support, signal detection, aggregate reporting, and regulatory compliance services.
Patient access and support services
Design and operation of patient access programs addressing affordability, adherence, and payer authorization challenges.
SDOH assessment and tailored patient access design
Assessment of social determinants of health for patient populations and design of targeted access interventions and program modifications based on SDOH findings.
Travel-concierge and participant logistics services
Operational logistics and concierge services to remove travel-related barriers for study participants in global clinical trials.
Technology solutions and software integrations
Deployment and integration of platforms for RWE generation, PV reporting, safety databases, EDC/CTMS/eTMF, CRM, and analytics to support program operations.
Evidence development services
Consulting and execution of observational, registry, and real-world studies to generate evidence for regulatory, payer, and clinical stakeholders.
Safety & risk management services
Pharmacovigilance operations, REMS program support, signal detection, aggregate reporting, and regulatory compliance services.
Patient access and support services
Design and operation of patient access programs addressing affordability, adherence, and payer authorization challenges.
SDOH assessment and tailored patient access design
Assessment of social determinants of health for patient populations and design of targeted access interventions and program modifications based on SDOH findings.
Travel-concierge and participant logistics services
Operational logistics and concierge services to remove travel-related barriers for study participants in global clinical trials.
Technology solutions and software integrations
Deployment and integration of platforms for RWE generation, PV reporting, safety databases, EDC/CTMS/eTMF, CRM, and analytics to support program operations.
Expertise Areas
- Real-world evidence generation
- Rare-disease evidence generation and patient-centric study design
- Pharmacovigilance and drug safety operations
- REMS program design and governance
Key Technologies
- Real-world data platforms (ingestion, normalization, storage)
- Privacy-first data connectivity and linkage
- Pharmacovigilance reporting and analytics platforms
- Safety database systems