The many facets of compliance
Compliance is a word that carries a lot of weight within the world of clinical trials.
If security is the immune system in our application that identifies and neutralises threats, often before you notice them, then compliance is the memory and intelligence that guides it—knowing what to look for, how to respond, and when to escalate. Together, they protect the whole system.
It’s one thing to tick the boxes of regulations, ethics, industry standards, and patient safety, but when you extrapolate that out across international trials (with locally driven regulations), cultural nuances, a myriad of clinical variables and trial aspirations, the complexities multiply exponentially.
At Spiral, we have embraced this challenge by adopting the European Medicines Agency Guideline for Computerised Systems so that your trials can be validated and compliant. More frameworks will follow.
Areas of compliance in clinical trials include:
Compliance is multi-facted. Delving a little deeper into compliance drivers helps explain why our platform does what it does. Meeting all compliance steps is important for all trials so that scientific results can be considered valid.
Regulatory Compliance: The governing bodies in the trial’s location(s) dictate what regulations must be followed. Examples include the FDA (Food and Drug Administration) in the UK, GAMP5, and the EMA (European Medicines Agency) in Europe.
Good Clinical Practice (GCP): GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human participants. It includes ensuring informed consent, monitoring adverse events, and maintaining confidentiality.
Ethical Compliance: Ensuring that the trial is ethically sound and that participants' rights and safety are protected. This includes informed consent, where participants are fully informed about the trial and its risks before agreeing to participate.
Protocol Adherence: The study must be conducted according to the approved protocol, which outlines the trial's design, objectives, methodology, and statistical considerations. Deviating from the protocol without proper justification could lead to non-compliance.
Data Integrity: Ensuring the accuracy, completeness, and reliability of data collected throughout the trial. This includes keeping accurate records and reporting results truthfully without falsification or manipulation.
Safety Monitoring and Reporting: Spiral monitors participant safety during the trial and reports any adverse events or changes to their condition(s) in a timely and accurate manner. It ensures this by asking foundational compliance questions at key stages throughout the trial, removing the chance of these steps being forgotten.
Compliance in practice:
Compliance is embedded in everything we do. Our default approach is to use robust, compliant methods that ensure your data remains safe and secure. Guided by the principle of kaitiakitanga—a commitment to responsible stewardship—we add value to your trials by offering thoughtful improvements that enhance both functionality and compliance.
What do we consider when bringing your project to life?
Is it intuitive and easy to use?
Will it generate the “right” data for meaningful statistical analysis?
Does it meet all relevant compliance requirements?
Is every element ethically sound?
Compliance as DNA:
Compliance is not a static checklist—it’s an active, evolving practice that underpins every aspect of a successful clinical trial. At Spiral, we approach it as both a foundation and an opportunity: to safeguard your data, uphold ethical standards, and support robust, credible outcomes. By aligning with trusted frameworks and applying our principle of kaitiakitanga, we help you navigate complexity confidently, ensuring your trial is compliant, thoughtfully designed, and ethically sound.
~ Audrey Shearer, Founder & CEO, Spiral Software
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.
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