Trial compliance without the complexity

Meet and manage your trial compliance requirements. Ensure the integrity and reliability of your clinical trial, safeguarding participants and data integrity.

International compliance coverage

Ensure that requirements are  met across international accepted governing agencies, including FDA, EMA, and local regulations.

Patient-centric & ethically driven

Protect the health and safety of trial participants through consent modules and real-time monitoring.

Data & protocol integrity

Capture accurate and reliable trial data with traceability and reporting functionality.

  • Built to support local standards


    Whether your trial is local or international, Spiral supports requirements across major governing agencies including FDA, EMA, and local regulatory bodies. We take the pressure off by embedding these standards into your trial from the start.

  • Conditional checks to reduce queries

    Asking the right questions at the right time prevents missteps and saves effort. Spiral’s built-in conditional logic reduces unnecessary queries and supports compliance as your trial progresses.

  • Ensure trial participants are involved based on their eligibility

    Monitor and maintain compliance with study protocols and regulatory requirements based on participants’ unique scenarios.

  • Customisable reporting

    Generate reports that meet local regulatory requirements while enabling time-sensitive decision-making on a global scale.

  • Monitor and report on your trial at any time

    Enhance the safety and validity of your trial by reporting events in real time.

  • Our software evolves with you

    We actively monitor regulatory changes and update our systems accordingly so your trial doesn’t miss a beat.

  • Complete transparency with audit-ready data management, version control, and secure data logging.

Product features

“Our platform is designed to simplify the compliance process, which can be overwhelming. Helping you navigate regulatory challenges while protecting your data integrity is what we’re committed to as part of a robust global software platform.

Compliance isn’t about box-ticking – it’s about trial integrity, patient safety and advancing global healthcare in a scientific manner. Our goal is to make software compliance effortless for our clients.”

Audrey Shearer, Founder & CEO, Spiral Software.

Learn how

Our platform ensures compliance by providing secure, audit-ready data management, robust access controls, and full traceability of electronic records, aligning with regulatory expectations for integrity, reliability, and transparency in clinical research.

Global clinical trials with confidence