Traditional eClinical platforms are built for big pharma. Too slow, too expensive, and too complex for a lean team burning cash. Castor is different. We help small biotech teams launch trials in weeks and build the audit-ready data that holds up to FDA review and Series C diligence.
Trusted by Series A, B, and C biotech teams worldwide
Electronic data capture with real-time site oversight
Patient and clinician outcomes on any device
Regulatory-grade consent with full audit trail
Fixed-fee DM team, zero CRO layer
Your electronic data capture system should enforce data quality continuously, not surface problems at lock. Castor applies ALCOA+ principles at the point of entry: every field has a timestamp, every change has an audit trail, and every site has real-time access to outstanding queries.
Start collecting health economics and outcomes research (HEOR) data from Phase I and II, not Phase III. This evidence base supports HTA and payer discussions at licensing negotiations and strengthens your Series B or C fundraising narrative with data most competitors simply do not have.
Most small biotech teams cannot staff a full clinical data management function in-house. Castor’s fixed-fee data management service gives you a team with an average of 11 years of tenure, acting as a direct extension of your clinical operations. No variable billing, no layers between you and the data.
Intermediate layers between you and your data team
Castor runs across molecule types and therapeutic modalities. The same validated platform that powers a 15-patient FIH study handles a 100-patient multi-country Phase III.
FDA-regulated gene therapy trials across Phase I through Phase III, including multi-country studies with complex dosing and safety reporting requirements.
Advanced cell and gene therapies requiring specialized audit trail, cryopreservation logistics tracking, and cross-site data coordination.
Monoclonal antibodies and biologics in oncology, immunology, and inflammatory disease. Supports adaptive designs and biomarker-driven endpoints.
Clinical evidence generation for AI-powered diagnostic platforms, including imaging endpoints and real-world validation studies.
Wearable-integrated data collection and decentralized clinical trials for neuromodulation devices and digital therapeutics.
Small patient populations, orphan drug designations, and multi-language consent workflows for rare disease and pediatric indications globally.
After implementing Castor as their PMCF data collection platform, MMI increased study enrollment by 500% while producing the audit-ready documentation required for EU MDR compliance. Castor’s eCRF builder and Professional Services team helped MMI move from protocol design to first patient enrollment significantly faster than their previous approach.
OncoBioMix is a founder-led oncology biotech running Phase II studies with a small internal clinical team. Rather than building a full data management function or adding a CRO layer, they used Castor’s fixed-fee data management service and built their trial operations directly in the platform.
A single study coordinator managed the full trial operation. Castor handled database build, query management, and data lock. The result was $100,000 in staffing cost savings without any compromise on data quality or inspection readiness.
“Castor gave us the infrastructure of a big-pharma trial without the headcount of one. Our data is inspection-ready and our team is the same size it was on day one.”
Dr. Michael Liss, OncoBioMix
Castor is built to the regulatory standards that matter for a biotech submission. ICH E6(R3) took effect in the EU in July 2025 and in the US in September 2025. Castor’s unified data layer already meets the quality management and data integrity requirements of the updated GCP guidance.
Real-world evidence studies and post-market registries follow the same validated infrastructure as interventional trials.
Yes. Castor supports gene therapy, CAR-T, mRNA, mAbs, and rare disease trials across Phase I through post-market. The platform handles complex dosing logic, multi-site coordination, and the audit trail requirements specific to advanced therapy medicinal products regulated by FDA and EMA. Our molecule-agnostic design means the same validated platform works for a 15-patient first-in-human study and a 100-patient multi-country Phase III.
Audit-ready data means every data point has a complete, tamper-evident audit trail from entry to lock: who entered it, when, and what changed. For an FDA submission, this means your 21 CFR Part 11-compliant audit log can be exported and reviewed by an inspector without remediation. Castor enforces ALCOA+ principles at the system level, so audit readiness is built into the data collection process rather than applied as a cleanup step before submission.
ePRO and eCOA data collected in Phase I and II creates a health economics and outcomes research (HEOR) evidence base that supports payer negotiations, health technology assessment submissions, and licensing discussions at Series B or C. Investors and acquirers treat this data as a value signal. Companies that start collecting quality-of-life and patient-reported endpoints early arrive at late-stage fundraising with evidence that most competitors built only in Phase III.
Yes. Castor’s fixed-fee data management service is designed for teams without in-house DM capacity. Our data managers, who average 11 years of tenure, act as an extension of your team: building the database, managing queries, running data quality checks, and delivering clean data for lock. There is no CRO layer and no variable hourly billing. OncoBioMix ran a complete clinical operation with one study coordinator using Castor for data management, reporting $100,000 in staffing cost savings.