Castor Professional Services

Interventional trials, from first consent to database lock

Castor runs interventional clinical trials end to end: study build with randomization, eConsent enrollment, eCOA (electronic clinical outcome assessment) endpoint capture, and AI-assisted extraction of source data into the eCRF (electronic case report form) with human review. The extraction serves prospective interventional trials as well as post-market studies.

patient compliance in specific interventional trials
Up to 0 %
protocol-to-live study builds for low-complexity studies
0 + weeks
studies currently running on Castor
0 +
 
 
Trial operations

Interventional rigor without the systems sprawl

Randomized trials fail operationally in predictable places. Each card below leads with what runs differently on Castor.

1

Amendments that stall the database mid-study
No-code amendments with re-consent built in

Participants consent from home or in clinic, with re-consent flows ready for the amendments a decade-long registry will inevitably see. Teams using Castor eConsent have seen enrollment improve 2x to 5x.

2

Endpoint data arriving late and dirty
eCOA endpoints with real-time edit checks

Patients report from their own devices with edit checks at entry, reaching up to 92% compliance in specific interventional trials.

3

Site staff re-typing source documents into the eCRF
AI-assisted extraction with human review

Castor Catalyst moves source data into the eCRF at 39 to 6 minutes per chart, with a post-QC (post-quality-control) error rate of 0.8% against 6.6% manual, and every value reviewed by a person.

4

Monitoring budgets consumed by travel
Remote source document capture in the EDC

Source documents live in the EDC (electronic data capture) system itself, the model Gameto used to run 100% remote monitoring across 4 continents.

Capabilities by stage

From randomization in clinical trials to database lock

Four stages, one platform, one audit trail. No hand-offs between systems at the moments that decide data quality.

Build and randomize

Build the study in Castor EDC without code, with randomization built into the platform, so allocation, enrollment, and capture share one system. Need the fundamentals first? Start with how randomization works in clinical trials.

Enroll and consent

eConsent enrolls participants remotely or on site, with a 73.6% consent-form conversion rate across eConsent studies and re-consent flows ready for amendments.

Capture endpoints

eCOA and ePRO (electronic patient-reported outcomes) capture primary and secondary endpoints on validated instruments, from patients’ own devices or provisioned hardware.

Verify and lock

Castor Catalyst extracts source data into the eCRF with human review, and clinical data management carries the study to database lock on the same audit trail it started with.

Phase coverage

Early phase to post-market, without changing systems

Early phase

Lean teams, fast builds: low-complexity studies go live in 6+ weeks, so a Phase I or pilot study does not wait on enterprise timelines.

Pivotal trials

Multinational Phase III scale: one program brought 1,000+ patients live on the ePRO app within 2 months across 50+ sites, at 92% compliance.

Post-market

The same platform carries post-market follow-up and PMCF (post-market clinical follow-up) studies, so evidence generation continues after approval without a systems change.

Proven outcomes

Proven outcomes on Castor

9 concurrent studies across 4 continents, run by a clinical operations team of three

Gameto, biotech, randomized and interventional programs on Castor (published case study).

US IND clearance

Investigational New Drug application cleared on an entirely ex-US dataset (Gameto)
patient compliance in specific interventional trials
Up to 0 %
study builds (a 63% build-time reduction) at a neuroscience research institute
0 x faster
eConsent one-time-passcode success rate
0 %
In the field

Interventional programs running on Castor

Biotech / randomized programs

3-week builds that held up to the FDA

Protocol-to-live database builds in 3 weeks including full Spanish localization, 9 concurrent global studies with a clinical operations team of three, and a dataset accepted by the FDA for immediate Phase 3 entry.

“We don’t have six months to set up a database… we had that flexibility to adjust on the fly without losing quality.”

christian kramme gameto

Christian Kramme,
Chief Scientific Officer, Gameto

Rated on independent review platforms

Recognized by independent analysts

Rated strongly for customer loyalty in ISR’s 2025 eCOA/ePRO Benchmarking.

For evaluation teams

About Castor for interventional trials

An interventional trial assigns participants to a treatment, device, or procedure according to a protocol, usually with randomization and a comparator. An observational study, including registries and natural history studies, collects data on routine care without assigning treatment. Castor runs both designs on one platform, so the registry that generated a hypothesis and the randomized trial that tests it share the same system and audit trail.

For interventional programs specifically, Castor covers the full arc: no-code study build with randomization included, eConsent enrollment with re-consent for amendments, eCOA endpoint capture on validated instruments, and data management through database lock. Castor Catalyst provides AI-assisted extraction of source data into the eCRF for prospective interventional trials, with every value reviewed by a person before it enters the record.

The platform carries 19,000+ studies to date, platform-wide across every study design, with 6,000+ currently running. Sponsors, CROs, and academic teams run interventional programs on it from early phase through Phase III and into post-market follow-up.

Common questions

Frequently asked questions

An interventional clinical trial assigns participants to a treatment, device, or procedure according to a protocol, usually with randomization and a comparator, to measure the intervention’s effect. It is the design behind most regulatory approvals, from early-phase safety studies through pivotal Phase III programs.

In an interventional trial the protocol assigns the treatment. In an observational study, including registries and natural history studies, participants receive routine care and the study only collects data. Castor runs both designs on the same platform, so a sponsor can move from a registry to a randomized trial without changing systems.

Yes. Randomization is built into the Castor platform, using a variable-block model with stratification, configured during study build without code, so randomized controlled trials run enrollment, allocation, and data capture in one system with one audit trail.

Yes. Castor Catalyst provides AI-assisted extraction of source data into the eCRF for prospective interventional trials as well as post-market studies, with every value reviewed by a person before it enters the record. Measured performance: chart processing time from 39 to 6 minutes with a post-QC error rate of 0.8%, against 6.6% for fully manual entry.

Study teams apply amendments themselves in Castor’s no-code builder, without vendor change-order queues, and eConsent re-consent flows carry the change to participants. The built-in audit trail records every version.

Castor supports interventional trials from early phase through pivotal Phase III programs and post-market studies. On the platform today, 6,000+ studies are currently running, and one multinational Phase III program brought 1,000+ patients live on the ePRO app within 2 months across 50+ sites at 92% compliance.

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