Small patient populations. Dispersed geographies. High patient burden. Castor’s unified EDC, ePRO, and eConsent platform is designed for the realities of rare disease, not adapted from them.
Rare disease research operates under constraints that standard trial platforms were never designed to handle. Patient populations are small, often geographically scattered, and frequently include paediatric or vulnerable cohorts. The result: sponsors face protocol deviations driven by site burden, dropout rates exacerbated by onerous visit schedules, and data quality errors that cannot be tolerated when every patient is irreplaceable.
Rare disease trials struggle with enrollment. Every patient who drops out due to travel burden or confusing assessments represents a material setback to a programme with no replacement pool. Patient compliance is not a quality metric. It is the study itself.
In large trials, a handful of data entry errors are a rounding error. In a rare disease study with 40 patients, a 6.6% manual extraction error rate means 2-3 corrupted records that could invalidate an endpoint. Data accuracy is a scientific imperative, not an operational preference.
Rare disease protocols often combine EDC data capture with validated patient-reported outcomes, caregiver-reported outcomes, and functional assessments, typically handled by separate vendors, creating reconciliation overhead and data integrity risk.
Reaching patients in 160+ countries requires multi-language support, local regulatory compliance, and the ability to onboard sites quickly. Decentralized clinical trials tools remove the need for dedicated in-country infrastructure for each market.
Manual data extraction averages 6.6% error rate across the industry. Castor Catalyst’s automated EHR ingestion delivers a 0% error rate by eliminating manual transcription entirely. In small-N rare disease studies, this is the difference between reliable data and a compromised endpoint.
Castor Catalyst combines AI-powered retrospective EHR extraction with prospective ePRO/EDC data capture on a single platform, enabling rare disease teams to build a comprehensive natural history baseline alongside an active interventional study. This approach to real-world evidence generation requires no separate system or additional validation overhead.
Castor Connect delivers eCOA solutions deployable as BYOD or on provisioned devices, with ClinRO for site-administered assessments. SMS and WhatsApp reminders via Twilio, offline mode with automatic sync, and 24/7 multilingual patient support in 15-20 languages drive up to 95%+ compliance. Rated #1 for user friendliness among ePRO providers (ISR 2023). All data captured securely in Castor Connect — 21 CFR Part 11 and HIPAA/GDPR compliant. The platform is available in 80+ languages.
eCOA data flows directly into the electronic data capture system, with no manual data transfer, no reconciliation delays between separate vendor platforms, and no integration tax. One source of truth from first patient in to database lock, with no second vendor relationship to manage.
Dynamic, multimedia-supported eConsent for paediatric, caregiver, and adult rare disease populations. Supports guardian and legally authorised representative (LAR) consent, re-consent workflows for protocol amendments, and multi-country regulatory requirements.
eCOA data flows directly into the electronic data capture system, with no manual data transfer, no reconciliation delays between separate vendor platforms, and no integration tax. One source of truth from first patient in to database lock, with no second vendor relationship to manage.
Full regulatory compliance built in across all study types and jurisdictions. FDA 21 CFR Part 11, ICH E6(R2/R3), EU Annex 11, GDPR, and HIPAA validated, with support for FDA rare disease guidance and the February 2026 single-pivotal-trial framework for orphan drug programmes. No separate implementation project required when adding a new indication or market.
A unified EDC, ePRO, eConsent, and RWE platform designed for the precision, patient-centricity, and global reach that rare disease research demands.
Rare disease studies on the Castor platform. Small-N, complex-endpoint, multi-country trials. Castor has the track record to handle the full spectrum of rare disease research.
By deploying Castor’s unified EDC, ePRO, and eConsent platform, Mahana bypassed the integration overhead of legacy vendors, reducing study timelines by 58% and cutting operational costs by up to 4-5x versus prior vendors. A benchmark for what biotech clinical trials achieve when platform integration costs are removed.
Nearly 5,000 patients captured at a single centre (Radboud UMC), proving Castor can handle high-volume single-site oncology registries with complex longitudinal data requirements.
Yes. Castor is designed for the precision that small-N rare disease studies demand. The unified EDC and eCOA platform captures clinical, patient-reported, and caregiver-reported data in a single database, eliminating reconciliation errors. Castor Catalyst’s automated data ingestion delivers a 0% error rate versus a 6.6% industry average for manual extraction. In a 40-patient rare disease study, data accuracy is not an operational preference. It is a scientific requirement.
Castor’s DCT toolkit includes remote eConsent, ePRO deployable as BYOD or on provisioned devices, SMS and WhatsApp reminders, offline mode with automatic sync for low-connectivity settings, and telemedicine visit scheduling, enabling patients to participate from home across 160+ countries without frequent site visits. 24/7 multilingual patient support further reduces the burden on sites. This is particularly valuable for rare disease patients who may live far from specialist centres or who have limited mobility.
Yes. Castor supports 190+ validated instruments out of the box, including PROMIS, EORTC, and EQ-5D, with the flexibility to quickly configure paediatric and caregiver-reported assessments. Castor’s eConsent supports guardian and legally authorised representative consent workflows for paediatric and cognitively vulnerable populations.
The Castor platform is available in 80+ languages and has been used in studies across 160+ countries. 24/7 multilingual patient support is available in 15-20 languages, reducing site burden for tech issues throughout the study. Site onboarding, regulatory compliance, and data capture standards are all configured per-country within the same unified platform, without requiring country-specific software instances. The platform is validated for FDA 21 CFR Part 11, ICH E6(R2/R3), EU Annex 11, GDPR, and HIPAA.
Yes. Castor Catalyst uses AI-assisted EHR ingestion specifically designed for natural history studies, achieving a 0% EHR extraction error rate compared to a 6.6% industry average. This makes it well suited for orphan drug development programmes that rely on retrospective patient data and registries prior to interventional trial design.
Castor is compliant with FDA 21 CFR Part 11, ICH E6(R2) and E6(R3), EU Annex 11, GDPR, and HIPAA. For rare disease and orphan drug programmes, the platform supports FDA’s February 2026 single-pivotal-trial guidance framework and decentralized trial designs required to enroll geographically dispersed patient populations.
