Castor

Run clinical trials at the speed of your science

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.

Biotech studies

500+

Biotech clients

85+ ePRO compliance rate

92%

G2 rating

4.65/5

The biotech clinical ops reality

“Every week your trial sits in setup is runway you’re not getting back.”

“Your data has to survive a due diligence room you don’t control.”

“A four-person clinical team cannot also be a data management department.”

One platform, not four systems

Everything your trial needs in a single validated environment

EDC

Electronic data capture with real-time site oversight

ePRO / eCOA

Patient and clinician outcomes on any device

eConsent

Regulatory-grade consent with full audit trail

Data management

Fixed-fee DM team, zero CRO layer

EDC + eCOA + eConsent

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.

Patient login success rate across eCOA studies

99.02%

ALCOA+

Data integrity principles enforced at field level

Part 11

FDA 21 CFR Part 11 compliant across all modules

ePRO that builds your Series C case

Quality-of-life data collected in Phase I becomes valuation evidence in Phase III. 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.

BYOD

Patient’s own device supported, no provisioning cost

Phase I+

Start HEOR data collection from first-in-human

Data management without the overhead

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.

Molecule and modality coverage

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.

Gene therapy

FDA-regulated gene therapy trials across Phase I through Phase III, including multi-country studies with complex dosing and safety reporting requirements.

mRNA and CAR-T

Advanced cell and gene therapies requiring specialized audit trail, cryopreservation logistics tracking, and cross-site data coordination.

mAbs and biologics

Monoclonal antibodies and biologics in oncology, immunology, and inflammatory disease. Supports adaptive designs and biomarker-driven endpoints.

AI diagnostics

Clinical evidence generation for AI-powered diagnostic platforms, including imaging endpoints and real-world validation studies.

Neuromodulation and digital health

Wearable-integrated data collection and decentralized clinical trials for neuromodulation devices and digital therapeutics.

Rare disease and pediatric

Small patient populations, orphan drug designations, and multi-language consent workflows for rare disease and pediatric indications globally.

Castor in biotech

The numbers behind 500+ biotech studies

Biotech studies on platform

500+

Sites connected globally

8,000+

Participants enrolled

200K+

Biotech data points captured

24M+

Biotech clients

85+

Regulatory readiness

Data that survives FDA review and due diligence

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.

Common questions from biotech teams

Does Castor support gene therapy and CAR-T clinical 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.

What does audit-ready data mean for a biotech FDA submission?

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.

Can a small biotech team run a clinical trial on Castor without a full data management team?

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.