From clinical observation to registered, managed study.
The full start-up, regulatory, and ongoing-management layer for physician-led studies, sponsor programs, and patient registries — priced so an independent investigator can actually use it.
Everything below is a service we operate today. Each section links to a focused part of the workflow — and every one of them stops at the same line: documentation and infrastructure from Beacon; clinical, ethical, and regulatory decisions from the people licensed and responsible for them.
Study start-up & site activation
Turning a clinical observation into a running study takes paperwork before it takes patients. We prepare the start-up package: protocol drafts in registry-shaped language, IRB-ready supporting documents, site information, and activation packets for multi-site programs. Each participating site gets the intake, consent, and data-capture scaffolding it needs from day one.
- Protocol and registry documentation drafting
- Site activation packets and site-level workflows
- Harmonized intake and consent across sites
Regulatory affairs
We prepare regulatory documentation and support correspondence so your team can move through the process with cleaner materials. That includes Investigational New Drug (IND) application support, drafting and organizing FDA correspondence, expanded-access requests built around FDA Form 3926, and IRB readiness packages. Final decisions rest with FDA, the IRB, and your responsible parties — our job is to make the paperwork review-ready, not to promise outcomes.
- IND application preparation support
- FDA correspondence drafting and organization
- Expanded access requests (Form 3926)
- IRB readiness packages and commercial IRB coordination
ClinicalTrials.gov registration support
For eligible studies we support Protocol Registration and Results System (PRS) submission, including eligibility checks against FDAAA 801 requirements, NIH policy, and ICMJE author guidance. We never imply a study has a pending NCT number until ClinicalTrials.gov confirms one — acceptance, review comments, and publication timing are controlled by ClinicalTrials.gov.
- PRS record drafting and submission support
- Eligibility checks (FDAAA 801, NIH policy, ICMJE)
- Annual record updates on managed studies
Observational & real-world evidence studies
Observational registries record what is already happening in clinical practice: structured intake, longitudinal follow-up, patient- and caregiver-reported outcomes, and safety observations. Reports are explicit about what observational data can and cannot support — hypothesis-generating, not randomized-trial-equivalent.
- Structured observational study frameworks
- Longitudinal outcome capture and follow-up workflows
- Sponsor-ready evidence reporting with clear data provenance
Patient registries
Disease- and therapy-focused registries with enrollment monitoring, follow-up reminders, dashboard upkeep, and aggregate reporting. Sponsors exploring a registry-based evidence strategy can start with a structured proposal conversation.
- Single-site and multi-site registry structures
- Site-level and aggregate reporting
- Sponsor registry proposals
Quality review
Before a study is submitted, our credentialed review team goes through the draft: refining ClinicalTrials.gov-style language, checking internal consistency, and flagging sections that need a stronger second look. The review is performed by the Beacon team operating under our credentialed Principal Investigator of record.
- Section-by-section draft review
- Registry language refinement
- Readiness scoring before submission
Monthly study management
Once a study is submitted, published, or activated, ongoing management runs on a simple monthly subscription: enrollment monitoring, follow-up reminders, dashboard upkeep, annual PRS updates when applicable, and periodic sponsor-facing reports for sponsor programs.
- Enrollment and follow-up monitoring
- Annual PRS record updates where applicable
- Periodic reporting for sponsor programs
Have a study in mind?
Start the draft free in a physician workspace, or contact us first if your program has regulatory or sponsor requirements we should know about.