Castor Catalyst turns clinical source data into structured data. In the Direct-to-Patient workflow, the participant retrieves their own clinical records through HIPAA release or FHIR. Catalyst extracts the data, a human reviewer accepts it, and the result is clean records.
Recruit participants and capture real-world EMR data without a single site visit. Replacing manual data entry with a streamlined, final review.
Direct-to-Patient routes through whichever pathway fits the study: a HIPAA release workflow, a Patient Right of Access (FHIR) workflow, or API integrations.
Most studies use a mix. FHIR for fast longitudinal data on routine fields. HIPAA release for depth where the protocol calls for unstructured documents or complex endpoints. API integrations for sponsor research programs where the same EHR vendors recur across studies.
Add participant-reported data. Pair retrieval with Castor ePRO: BYOD capture on participant devices, a validated instrument library (EQ-5D, FACT-G, SF-36, PROMIS, and 190+ more), real-time compliance monitoring, and multilingual support.
By using patient-mediated FHIR connections, you bypass the biggest bottleneck in observational research: waiting on busy site staff. Instead of relying on coordinators to manually dig through charts and transcribe information, data flows instantly from the EMR to your platform the moment the participant consents. This parallel processing can cut weeks, or even months, off the data collection phase of your trial.
Manual chart abstraction is notoriously prone to human error. A direct FHIR pipeline pulls the exact, unmodified structured data directly from the clinical source. This completely eliminates manual data entry errors in the EDC and practically removes the need for costly and time-consuming Source Data Verification (SDV), because the data in your platform is the source data.
When you remove the physical site from the data-entry equation, you eliminate the heavy costs that come with it. You are no longer paying for site initiation overhead, coordinator abstraction hours, or on-site monitoring visits. You can scale up recruitment, even across geographically dispersed participant populations, without a proportional spike in your budget.
Participants enroll directly. Catalyst pulls records on the study’s schedule of assessments. Already in production for GLP-1, oncology, and rare disease registries.
Especially for ultra-rare diseases where the population is dispersed and site-based recruitment is impractical.
Targeted retrieval for sponsors who know the participant profile they need to match against an interventional arm.
Long-tail observational data without the cost of standing up multi-site infrastructure. PASS and PMR studies.
Pre-enrollment record retrieval to confirm inclusion and exclusion criteria before participants are activated into a trial. Catalyst reads each chart against the criteria and surfaces who qualifies.
In a prospective GLP-1 registry running on the Castor platform, participants enroll on a study landing page, complete pre-screening, e-consent, and authorize FHIR-mediated retrieval of their EHR. Catalyst pulls the records, extracts the data, and lands it in the EDC.
The traditional version of this workflow takes around 40 hours of manual abstraction effort. On Catalyst, automated retrieval and extraction bring that under 4 hours.
3
4
5
Enrollment to records in the EDC
Castor Catalyst’s Direct-to-Patient workflow retrieves clinical records straight from a participant’s electronic health record system without requiring a site upload. After the participant enrolls and consents, Catalyst pulls their records through one of three pathways. HIPAA Release Authorization routes the request to the participant’s healthcare provider and returns the complete record, including unstructured documents, in roughly two weeks. FHIR API retrieval lets the participant log into a portal like MyChart and returns structured USCDI data in minutes to 24 hours. Direct API integration connects to EHR vendors including Epic, Cerner, and Athena for studies running across recurring sponsor sites.
The retrieved data flows through Catalyst’s AI extraction pipeline, gets mapped to CDISC CDASH standards, passes Human-in-the-Loop review by medically trained Castor staff, and lands in your Castor EDC with a Visual Audit Trail back to every source.
Direct-to-Patient is available in the US market. For global studies or studies where sites need to contribute source documents directly, see the Site Upload workflow. Studies that mix US and non-US sites can run both side by side with one combined audit trail.
The participant does. After enrolling and consenting, the participant either signs a HIPAA release (Catalyst routes the request to their provider) or logs into their EHR portal and authorizes FHIR access. Sites don’t pull records on Catalyst’s behalf. The participant retains control.
Through the mandatory Visual Audit Trail. Every extracted data point links back to its source location. A bounding box on a PDF. A FHIR resource ID for structured data. No value reaches the EDC until a reviewer confirms it against the source, so a hallucinated value cannot pass review unchecked.
Catalyst is one product with two entry points. If Direct-to-Patient isn’t quite the right fit for your study, here’s where to go next.
AI source-data extraction for clinical trials. The technology overview, both workflows, and the story in one place.
Sites upload any source document directly to Catalyst. PDFs, scans, paper PROs, handwriting. Works globally.
We’ll bring a worked example using one of your study types, a sample HIPAA release addendum, and a per-participant cost estimate.