SMi Trial

SMi Trial is a cloud-based, mobile-enabled platform developed by ScienceMedia for biopharmaceutical and medical device companies and Contract Research Organizations (CROs). It is designed to improve clinical trial protocol training and compliance, with the goal of reducing protocol deviations, alleviating screening failures, minimizing risk to data quality, and streamlining clinical trial timelines. The platform is built on ScienceMedia's MindFlow methodology, which draws on cognitive and behavioral learning theories to support individualized, self-paced learning journeys for each user.

SMi Trial is particularly suited to sponsors of multi-site trials dealing with complex or frequently changing protocols and staff turnover. It replaces traditional protocol training decks and outdated systems with a multimodal learning experience. In documented use, the platform recorded over one million views in its first year across a clinical trial deployment, indicating high engagement among site staff.

Core Training Capabilities

• Protocol Training: Delivers custom multimedia training targeted to high-risk areas of a protocol, with the aim of standardizing and elevating site performance.
• Just-In-Time Access: Provides online protocol and medical distance learning accessible from any device at any time, addressing knowledge loss over time through continuous mobile-enabled access.
• Interactive Schedule of Activities: Centralizes key study procedure instructions within an interactive, visit-specific guide for study teams.
• Virtual Investigator Meetings and Site Initiation Visits: Supports remote pre-training, self-paced microlearning, standardization, and assessments as alternatives to traditional in-person investigator meetings and site initiation visits.

Protocol Management and Compliance

• Protocol Amendment Management: Allows sponsors and CROs to deploy, track, and re-train staff on protocol amendments throughout the duration of a study.
• Study Updates: Enables distribution of targeted updates to address knowledge gaps identified during study execution.
• Integrated Assessments: Uses protocol-specific assessments to identify knowledge gaps and activities at high risk of deviation, supporting compliance with ICH E6(R2) guidelines.

Monitoring and Reporting

• Real-Time Analytics: Provides role-based analytics on training status and comprehension, allowing evaluation of site staff competency in real time.
• Audit-Ready Reports: Generates printable training completion records for study teams that are formatted for audit readiness.

SMi Trial is delivered as an integrable, cloud-based platform with mobile support across devices. It is designed to support decentralized trials and has demonstrated applicability in reducing protocol deviations, as documented in case studies involving top-tier CROs. Compliance documentation is built into the platform workflow to support regulatory and audit requirements.