Frequently asked questions.
What BeaconCR does, what it does not do, and how registries, IRBs, ClinicalTrials.gov, HIPAA, patient enrollment, and sponsor reporting actually work on the platform.
01.What is an observational registry?
An observational registry is a structured way to collect information about patients receiving a particular treatment, condition, or procedure without changing their care. It tracks outcomes, safety observations, and follow-up over time. BeaconCR builds the framework around the registry: intake, consent, follow-up workflows, dashboards, and reports.
02.Is this the same as a clinical trial?
No. A randomized clinical trial (RCT) assigns patients to treatment vs. control under a controlled protocol. An observational registry records what is already happening in real-world clinical practice. Observational data is valuable, but it is hypothesis-generating, not RCT-equivalent. BeaconCR is explicit about that distinction in every report.
03.Does BeaconCR provide medical advice?
No. BeaconCR is a research and registry infrastructure provider. It does not diagnose, treat, or advise patients. Clinical decisions are made by licensed physicians. Patient-facing pages explicitly state that submitting interest does not guarantee treatment, enrollment, or access to any therapy.
04.Does BeaconCR guarantee IRB approval?
No. BeaconCR helps prepare IRB-ready documentation — protocol drafts, consent templates, HIPAA authorization language, recruitment materials, and supporting attachments. IRB approval or exemption is the decision of the reviewing IRB or ethics committee. BeaconCR can pair you with an external commercial IRB; the IRB makes the determination.
05.Does BeaconCR guarantee ClinicalTrials.gov registration?
No. BeaconCR supports Protocol Registration and Results System (PRS) submission for eligible studies, including eligibility checks against FDAAA 801, NIH policy, and ICMJE. NCT assignment, acceptance, review comments, and publication timing are controlled by ClinicalTrials.gov. We never imply a study has a pending NCT until ClinicalTrials.gov confirms one.
06.Can a physician use BeaconCR for regenerative medicine?
Yes. BeaconCR is built for physicians working in regenerative medicine, orthobiologics, functional medicine, neurology, longevity, pain, rehabilitation, and other emerging therapeutic areas. The registry framework helps you capture patient-reported outcomes and safety observations responsibly without overclaiming what the data proves.
07.Can biotech sponsors use BeaconCR for real-world evidence?
Yes. BeaconCR supports biotech sponsors building registry-based evidence strategies, activating physician sites, organizing observational data collection, and structuring real-world evidence programs around investigational or commercially available products, as appropriate. Reports clearly distinguish observational data from RCT data.
08.Can patients enroll directly?
Patients can submit interest through a registry-specific intake form or by physician referral. Submitting interest does not guarantee treatment, enrollment, eligibility, insurance coverage, or access to an investigational therapy. A licensed physician and the appropriate research oversight process determine whether participation is appropriate.
09.How is patient data protected?
Patient records are encrypted at rest using AES-256-GCM at the field level. Every read and write is audit-logged in a hash-chained log. Access is restricted to authorized study personnel. Patients can withdraw at any time. See the Security & Privacy page for the full breakdown of encryption, access controls, retention, breach response, and BAA posture.
10.Does BeaconCR support HIPAA workflows?
Yes. BeaconCR operates as HIPAA-aware infrastructure: HIPAA authorization language inside consent forms, access controls and audit logging, minimum-necessary data discipline, de-identification options for exports, and a Business Associate Agreement (BAA) for covered-entity partners. HIPAA-aware means we operate per HIPAA requirements; "HIPAA-certified" is not a thing the law issues.
11.What does monthly registry management include?
The $119/month Active Registry Management covers ongoing maintenance once a registry is live: enrollment monitoring, follow-up reminders, dashboard upkeep, annual PRS updates when applicable, sponsor-facing periodic reports for sponsor programs, and routine support for the responsible party. It begins when the study is submitted, published, or activated — not while it is still a draft.
12.Can BeaconCR help with informed consent?
Yes. BeaconCR drafts study-specific informed consent forms (ICFs) covering purpose, procedures, risks, benefits, alternatives, voluntary participation, withdrawal rights, data handling, and contact information. Final ICF language is approved by the IRB. The platform tracks consent versioning so every patient is linked to the exact consent they signed.
13.Can BeaconCR help with patient-reported outcomes?
Yes. Registries can be configured to capture validated patient-reported outcome (PRO) instruments at baseline and at scheduled follow-up intervals. Patients receive reminders. Dashboards show enrolled-patient counts, follow-up rates, and outcome trends. PRO data can be exported with a data dictionary for biostatistics teams.
14.Can BeaconCR help with IRB readiness?
Yes. BeaconCR prepares the IRB submission package: protocol, consent and HIPAA authorization, recruitment materials, investigator brochure references when applicable, site information, and supporting attachments. We can also coordinate submission to an external commercial IRB. The IRB makes the determination — BeaconCR prepares the materials that make the determination easier.
15.Can BeaconCR support multi-site registries?
Yes. Multi-site coordination includes site activation packets, site-level dashboards, central IRB coordination where applicable, harmonized intake and consent across sites, and aggregate plus per-site reporting. Each site sees its own enrolled patients and follow-up rates; sponsors see aggregate registry-level summaries.
16.Can BeaconCR help with sponsor reports?
Yes. Sponsor-facing reports include enrolled-patient counts, follow-up rates, outcome trends, safety observations, registry-level summaries, data provenance, capture-rate metrics, and missing-data notes. Reports are clear about what observational data can and cannot support. Investor and partner-facing report templates are also available.
Question not on the list?
Send it to Tamara directly. She reviews every inquiry personally.