Clinical Trial Compliance Software

    Full control from protocol to closeout

    Clinical trials are complex, high-pressure, and heavily regulated. GxP Track℠ simplifies organizational data compliance from day one, giving your team the tools to manage protocol adherence, user training, and audit readiness across every site and study.

    FDA 21 CFR Part 11

    Compliance Friendly

    EU Annex 11

    Compliance Friendly

    ISO 27001

    Compliance Friendly

    SOC 2

    Compliance Friendly

    Build organizational data compliance into your workflow

    Keep trials moving with fewer delays, cleaner data, and audit-ready records - from first site to final submission.

    Faster study startup

    Get sites set up with role-based access, training, & SOP alignment. No IT delays holding you back.

    Align with SOPs at scale

    Enforce version-controlled procedures & auto-assign training when protocols change.

    Spot deviations

    Flag, log, & follow up on protocol deviations in real-time - with full traceability built in.

    Audit-ready always

    Capture every event, sign-off, & change under a verified user identity. Stay inspection-ready.

    Seeking Phase I Participant Organizations (Confidential Source Code Disclosure Considered)

    What they miss, we deliver

    Other solutions

    Siloed tools for docs, training, & logs
    Manual protocol updates & tracking
    Delayed deviation reporting

    GxP Track℠

    Unified, traceable system built for trials
    Auto-distributed SOPs with version control
    Real-time deviation logs linked to events

    Complete trial oversight without the extra legwork

    Everything you need to stay agile, auditable, aligned, and inspection-ready throughout the trial lifecycle.

    Protocol distribution & control

    Distribute SOP updates instantly with full version control. Automatically reassign training to affected users so no one operates on outdated procedures.

    Training management

    Assign training based on site, user role, or study requirements. Track completion with timestamps, user identity, and digital sign-offs for full accountability.

    Real-time deviation logging

    Allow users to log deviations immediately as they happen. Each entry includes identity, time, and context - with automated escalation and optional CAPA linkage.

    Audit trails across all activity

    Maintain a unified log of every action across teams, sites, and systems. Capture who did what, when, and why. With searchability and export on demand.

    Flexible deployment

    Launch new sites, users, or trial phases without delays. GxP Track℠ adapts quickly. No custom dev. No long setup cycles. No heavy IT lift.

    See how it's working for teams like yours

    Check periodically for case study updates.

    80%

    Striving for faster review & release

    100%

    Striving for right-first-time output

    50%

    Striving for reduction in processes

    Built to scale alongside you

    Discover how GxP Track℠ scales to support quality, traceability, and organizational data compliance across other regulated industries.

    Life Sciences

    Drug Discovery

    Medical Device

    Pharmaceutical Companies

    Whether you're handing off to a CDMO or preparing for commercial launch, GxP Track℠ adapts across regulated environments without friction.

    Make every trial traceable

    Book a demo to see how GxP Track℠ helps clinical teams simplify organizational data compliance and move fast from protocol to submission.