Take a Video Tour
Yes, engaging videos are always a welcome way to introduce new concepts. Here's a 3-minute video overview of SMi Trial, its implementation in a clinical trial, and sample study results.Note: all information contained within is sample information only and does not identify a customer's proprietary and confidential study details.
Reduce Risk. Avoid Deviations. Optimize Studies.
The problematic training practice seen in most studies:
- A 100-page protocol results in a duplicative 100-slide PPT deck
- No special emphasis on highest risks for protocol deviations
- Some material is redundant to prior studies
- Training after the Investigator Meeting is passed down, diminishing training consistency
- New hire training requires a site visit, so onboarding personnel slows the trial
- PPT presentations from the Investigator Meeting prove to be only marginally effective
- Quick access to the relevant, refresher training material at later stages in the trial is difficult
Add the newly introduced ICH GCP E6 (R2) regulations in addition to CTTI guidance around risk identification and mitigation, and you have an increased demand on trial conduct, recording, and reporting including:
- Emphasized training focused on the highest risks for protocol deviation
- Measuring and recording the site personnel's understanding of the protocol
- Training should be:
- Targeted to trial, role, and experience
- Self-directed, just-in-time, practical, and relevant
- Placed in a platform to record completion and understanding
SMi Trial — Eliminate Protocol Deviations from Your Clinical Trials
The opportunity to avoid protocol deviations in clinical trials is something of a Holy Grail in clinical development, but for companies who understand the criticality of protocol-specific training, the quest may be less frustrating and futile.
SMi Trial is a revolutionary, results-backed solution used to significantly strengthen the successful operation of clinical studies by assessing training comprehension, identifying and training to vital knowledge gaps, and providing training completion documentation.
SMi Trial has been used in dozens of global Phase II and Phase III clinical trials across various therapeutic classes by world class biopharmaceutical and CRO organizations alike. SMi Trial:
- Focuses on the high-risk areas of a protocol
- Proactively detects and avoids protocol deviations by identifying and addressing knowledge gaps early
- Improves knowledge comprehension and retention through education
- Eliminates variances of traditional training through interactive, instructionally-sound multimedia material that keeps the learner engaged
- Is available on-demand on any device, thus facilitating targeted training and onboarding
- Provides inspection-ready documentation
Take Their Word for It, Not Ours
Here's what Biopharmas and CROs have had to say about their experience with SMi Trial:
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