STEPcare Trial

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Compliance isn’t a checklist. It’s a living part of every great clinical trial. 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. Compliance is an active, evolving practice that underpins every aspect of a successful clinical trial.

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About the trial

After successful resuscitation, patients who survive a cardiac arrest often remain severely ill and require intensive care. Controlling depth of sedation, body temperature and mean arterial pressure are potential treatments that may prevent brain damage. The STEPCARE trial aims to study how to best apply these interventions.

About the software

This is Spinnaker, a user friendly, bespoke application that helps researchers find answers to important medical questions. The team behind the platform can adapt the software to match your study and we are especially interested in doing this for novel trials.

Spinnaker is a cloud based, integrated software/database solution for randomising patients using any design methodology including response adaptive methods; backed up by an electronic data capture application that is intuitive and particular. The application also includes management functions to alert relevant people about events (e.g. SAE), to manage drug inventory and to report on progress.

You can read more on the Spinnaker website at spiral.co.nz or contact Audrey on [email protected]

You can get to know us a little better through our blog and social media pages accessed via the logout screen of this trial.

Made with love in New Zealand.