Three ways to work with Beacon.
Beacon builds the infrastructure around clinical research and patient access: the documentation, the data capture, the workflows, and the reporting. The clinical and regulatory decisions stay with physicians, IRBs, sponsors, and regulators — where they belong.
Clinical Research
Study start-up and site activation, regulatory documentation including IND support and FDA correspondence, ClinicalTrials.gov registration support, observational and real-world evidence studies, patient registries, quality review, and monthly study management.
- Study start-up & site activation
- Regulatory affairs documentation
- ClinicalTrials.gov registration support
- Observational & RWE studies
- Patient registries
- Quality review & monthly management
Patient Access
Structured expanded-access intake built around FDA Form 3926, pre-screening and recruitment workflows, and patient support throughout participation — with the treating physician making every clinical decision.
- Expanded access intake (Form 3926)
- Pre-screening & recruitment
- Patient support
Safety & Risk
Safety reporting and risk-management program support is an area we are building toward rather than a packaged service today. If your protocol carries specific safety or REMS obligations, contact us and we will tell you plainly what we can and cannot support.
- Safety workflow scoping
- Contact us to discuss
Where the lines are
Beacon provides research infrastructure, documentation support, and data workflow services. We do not provide medical care, we do not supply investigational products, and we do not guarantee regulatory outcomes such as IRB approval, FDA authorization, or ClinicalTrials.gov publication. Every engagement is structured around those boundaries.
Not sure which fits?
Describe your study, program, or patient-access need, and we will point you to the right place — or tell you if we are not the right fit.