Generate Real-World Evidence for Regulatory, Coverage, and Clinical Decisions

Real-world evidence from routine care informs regulatory submissions, payor coverage, and clinical practice.

We support patient registries and real-world data programs under approved protocols, with consent and privacy at the center.

From First Patient to Final Dataset

Routine care data is often fragmented, with inconsistent measures and follow-up. By building evidence collection into patient support, we connect access, adherence, and outcomes to help answer questions such as:

How do access delays relate to treatment persistence?
What do caregivers report about treatment over time?
How do outcomes differ across sites of care?

This approach is especially valuable in small populations where trials are short and follow-up is limited.

Each engagement starts with the outcomes your brand wants to understand and the audiences who will review the evidence, including regulators, payers, providers, and patients. Those priorities guide eligibility and data collection.

Your team designs the study protocol. PRO supports data capture through a registry, retrospective review of existing program data, or another approach suited to the question. We support intake training and patient outreach so screening and consent are ready for the first enrollee. Starting collection at launch helps capture the full treatment experience before details are lost.

Protocol-Led. Consent-Guided.

Patients learn about research at program enrollment and participate only after separate informed consent, with institutional review board approval where required, and authorization to release medical records. A registry coordinator manages patient and caregiver contact, consent, and status updates; a principal investigator oversees compliance.

Data collection follows the approved protocol, with attention to data integrity. Provider and caregiver reports, medical records, and established instruments help your team understand treatment experience over time.

Evidence Designed for Regulators, Payors, Clinicians, and Caregivers

Regulatory decisions: Evidence on long-term safety and treatment experience can inform regulatory submissions, including labeling updates and post-marketing commitments.

Payor coverage and reimbursement: Outcomes in routine care can inform the coverage and reimbursement discussions your team has with payors.

Caregiver and clinician information: Safety and treatment experience findings can inform educational materials shared through your approved medical channels.

Clinical practice and publication: Peer-reviewed publication and guideline development extend the evidence to the wider clinical community.

Next steps in development: Findings can shape decisions on new populations, dosing, and endpoints.

Patient Access, Built Around Every Patient and Every Case

What is the difference between real-world data and real-world evidence?

Real-world data are collected in routine care, and real-world evidence emerges when those data are analyzed to answer a defined question.

What information can PRO help collect?

Depending on the protocol, collection can include provider-reported clinical information, caregiver-reported measures, medical records, and established patient-reported instruments.

How does research participation relate to program enrollment?

Program enrollment helps identify potentially eligible patients, while participation follows separate eligibility criteria and informed consent under the approved protocol.

Why start collecting evidence at launch?

Evidence is strongest when collection begins with the first patient, since later questions from regulators and payors are difficult to answer without data captured from the start.

Can real-world evidence support a label update or payor coverage?

It can inform those discussions when the study design and data quality fit the question, though your team leads the analysis and submissions and decisions rest with regulators and payors.

What does data capture look like?

Registry data is captured through customized reporting fields within existing program workflows, with reporting defined at implementation.