AccuraTrials is clinical trial EDC software for research teams, sponsors, CROs, biotech companies, and academic medical centers. AccuraTrials.com provides electronic data capture, eCRF building, validation rules, query management, randomization, audit trails, and 21 CFR Part 11 workflows in one platform — deployed in days, not months.
AccuraTrials is AI-powered electronic data capture (EDC) software for clinical trials. It helps research teams build eCRFs, generate validation rules from plain English, manage queries, support 21 CFR Part 11 workflows, and deploy studies in days without a dedicated EDC programmer. AccuraTrials serves academic medical centers, biotech startups, contract research organizations (CROs), pharmaceutical sponsors, and clinical research sites running Phase I–IV and observational studies.
AccuraTrials is built for academic research teams, biotech companies, CROs, clinical sites, pharmaceutical sponsors, and organizations running regulated clinical studies who need faster study builds without vendor dependency.
AccuraTrials replaces legacy EDC workflows that require vendor tickets, dedicated programmers, manual edit-check builds, and slow protocol amendment cycles. It eliminates the need for separate systems for randomization, query management, and medical coding.
Electronic data capture (EDC) is the use of software to collect clinical trial data in electronic format, replacing paper case report forms. EDC systems provide validation rules, audit trails, query management, and regulatory compliance features required for FDA-regulated studies.
These are documented industry figures. AccuraTrials eliminates every one of these cost drivers — here's how.
Every protocol change in a legacy EDC requires expensive reprogramming, re-validation, and site retraining. AccuraTrials handles amendments with no-code tools and an AI rule engine — deployed in days.
Every day of delay is a day of direct operational cost. AccuraTrials removes bottlenecks with AI-powered workflows, real-time validation, and instant access to every site's data.
The majority of protocols change mid-study. Every amendment in a traditional EDC restarts the cost cycle. AccuraTrials was designed for amendments: no re-validation, no re-programming, no specialist ticket.
No other EDC does this. Tell the AI Rule Suggester what you need in plain English — "Age must be ≥ 18", "Onset date cannot be before consent date" — and it proposes the complete edit check. One click to apply.
Skip the weeks of manual specification writing. Upload your study protocol PDF, and AccuraTrials' AI instantly extracts variables, schedules, and parameters to generate your initial eCRF build.
Data entry mistakes happen. AccuraTrials' AI Copilot runs quietly in the background, analyzing inputs against clinical logic to catch anomalies standard validation rules miss.
Using AI in clinical trials requires trust. That's why AccuraTrials records the entire "thinking process" of the AI Copilot into the immutable audit trail. Human-in-the-loop is enforced, and everything is inspection-ready.
E-signature credential re-auth · Immutable audit trail · Automated Part 11 test harness runs on every build
The AI's logic, prompts, and suggestions are logged permanently. If the AI suggests a rule, the audit trail proves a human approved it.
Full subject lifecycle traceability · SDV workflow · Protocol amendment audit capture
Idle timeout (10 min warning / 20 min logout) · Device fingerprinting · 28 granular permissions
PHI field designation per eCRF · Role-scoped access to subject data · Full access audit trail
Configurable retention policies · Data access audit · Per-site user access controls
"Every data modification—whether by a site user, a monitor, or the AI Copilot—is logged with timestamp, user, reason, and prior value. Records cannot be altered after write."
AccuraTrials brought enterprise EDC capabilities within reach for our organization. The compliance features, ease of use, and no-code configuration were critical for our research operations at Phoenix-Aid.
If you don't find what you need, email jgui@accuratrials.com directly.
Request a Demo →30-minute demo with an AccuraTrials expert. See AI validation in action on your exact study type. Compliance docs available on request. No commitment.