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
1000 Continental Drive, Suite 600, King of Prussia, PA 19406, USA
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
Consulting and execution of observational, registry, and real-world studies to generate evidence for regulatory, payer, and clinical stakeholders.
Pharmacovigilance operations, REMS program support, signal detection, aggregate reporting, and regulatory compliance services.
Design and operation of patient access programs addressing affordability, adherence, and payer authorization challenges.
Assessment of social determinants of health for patient populations and design of targeted access interventions and program modifications based on SDOH findings.
Operational logistics and concierge services to remove travel-related barriers for study participants in global clinical trials.
Deployment and integration of platforms for RWE generation, PV reporting, safety databases, EDC/CTMS/eTMF, CRM, and analytics to support program operations.
Consulting and execution of observational, registry, and real-world studies to generate evidence for regulatory, payer, and clinical stakeholders.
Pharmacovigilance operations, REMS program support, signal detection, aggregate reporting, and regulatory compliance services.
Design and operation of patient access programs addressing affordability, adherence, and payer authorization challenges.
Assessment of social determinants of health for patient populations and design of targeted access interventions and program modifications based on SDOH findings.
Operational logistics and concierge services to remove travel-related barriers for study participants in global clinical trials.
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
News & Updates
Trade show attendance to present patient access, affordability, and adherence solutions.
Partnership to combine privacy-first data connectivity with evidence- and access-focused program design to offer modern observational study designs and enhanced patient access programs.
Announcement of a new pharmacovigilance reporting platform with aggregate reporting templates, real-time analytics, and faster ad-hoc reporting to support regulatory safety activities.
Recognition as a leader in pre-approval pharmacovigilance operations and a major contender in post-approval PV services.
Partnership to reduce REMS implementation burden and improve REMS data quality for mental health treatments.
Participation in HL7 FHIR Connectathon to demonstrate REMS administration software interoperability.
Trade show attendance to present patient access, affordability, and adherence solutions.
Partnership to combine privacy-first data connectivity with evidence- and access-focused program design to offer modern observational study designs and enhanced patient access programs.
Announcement of a new pharmacovigilance reporting platform with aggregate reporting templates, real-time analytics, and faster ad-hoc reporting to support regulatory safety activities.
Recognition as a leader in pre-approval pharmacovigilance operations and a major contender in post-approval PV services.
Partnership to reduce REMS implementation burden and improve REMS data quality for mental health treatments.
Participation in HL7 FHIR Connectathon to demonstrate REMS administration software interoperability.