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.
Product features
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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.
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Customisable reporting
Generate reports that meet local regulatory requirements while enabling time-sensitive decision-making on a global scale.
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Monitor and report on your trial at any time
Enhance the safety and validity of your trial by reporting events in real time.
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Our software evolves with you
We actively monitor regulatory changes and update our systems accordingly so your trial doesn’t miss a beat.
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Complete transparency with audit-ready data management, version control, and secure data logging.
“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.
