Risk Mitigation for Clinical Trials

SMi Trial mitigates clinical risk and decreases trial cost by optimizing study compliance throughout the lifetime of your clinical trial. Our just-in-time therapeutic and protocol training, risk-based assessments, and real-time analytics serve to elevate clinical competency, improve the power of your clinical data, and ensure patient safety.

"SMi Trial enabled us to convey and reinforce specific objectives for our complex program. The training modules provided our team foundational knowledge and details about study endpoints and objectives, which could not be easily drawn from the protocol, IB, or other core documents."

CRA — Top 10 Biopharma Company

In contrast to the current one-and-done training in clinical trials, SMi Trial can be integrated into your study workflow and accessed, monitored, and deployed throughout the lifetime of your clinical trial.

Protocol Training

Elevate and standardize site performance with custom multimedia training targeted to high-risk areas of your protocol.

Just-In-Time Access

Fight the "forgetting curve" and ensure your study team is always prepared with mobile-enabled access from any device, anytime, anywhere.

Interactive Schedule of Activities

Centralize key study procedure instructions with an interactive, visit-specific guide.


Protocol Amendment Management

Deploy, track, and re-train staff on protocol amendments throughout the lifetime of your study.

Audit-Ready Reports

Report the training completion of your study team with printable, audit-ready training records.

Study Updates

Share key lessons with custom updates targeting knowledge gaps discovered during the execution of the study.


Real-Time Analytics

Evaluate site staff competency in real time using role-based analytics on training status and comprehension.

Integrated Assessment

Identify knowledge gaps and activities at high risk of deviation and ensure compliance with ICH E6(R2) using protocol-specific training assessments.

Read our case study to learn how a top 5 CRO used SMi Trial to reduce protocol deviations.

Interactive eLearning Incorporates:

  • Protocol Essentials
  • Product Overview
  • Disease State
  • Standards of Care
  • Assessments
  • Content Extensions

The Pillars of SMi Trial

Targeted Clinical Risk Mitigation

Our clinical experts work with you to identify high-risk areas of your protocol to develop targeted training and assessments. Real-time analytics provide visibility into training comprehension in order to identify knowledge gaps before they lead to unplanned protocol deviations.

Improve the Power of Your Clinical Data

The prevention of unplanned deviations ensures the reliability of your clinical data and minimizes the loss of usable subject data, resulting in decreased operational costs and expedited time-to-market for life-saving therapies.


Elevating Clinical Competency

Standardize site performance and minimize the impact of staff turnover with just-in-time therapeutic and protocol-specific training targeted to high-risk areas.

SMi Trial Results

SMi Trial will help you complete your trial months ahead of schedule, as well as:

  • Reduce deviation rates
  • Save hundreds of thousands of dollars in      downstream monitoring
  • Lower overall subject costs
  • Expedite time-to-market

Take Their Word for It, Not Ours

Here's what Biopharmas and CROs have had to say about their experience with SMi Trial:

EVP, Global Clinical Trial Optimization — Top 5 CRO
"With the complexity of current trials, it is more important than ever before to ensure research sites and project teams are well trained and truly comprehend the indications and protocols. We're leveraging SMi Trial to reduce the risk of errors by mandating compelling training focused on the highest risks within a trial to raise the clinical competency of sites throughout the duration of the trial."

EVP, Clinical Trial Delivery — Top 5 Biopharma
"As an SIV surrogate, this approach is phenomenal. I was pleasantly surprised by the neatness of the presentation. This is great for SIV supplement."

Director of Training Operations — Top 5 CRO
"The format is a refreshing solution that allows training to be developed that provides interest and education, allowing the key elements of the study to be emphasized and most importantly, easily facilitates tailored education based on role and level of experience."

CRA — Top 10 Biopharma
"The multimedia format was by far the best approach as it enabled us to convey & reinforce specific objectives for our complex program. The training modules provided our team foundational knowledge and details about study endpoints and objectives which could not be easily drawn from the protocol, IB, or other core documents."

EVP, Medical Affairs — Top 5 CRO
"SMi Trial leverages industry leading approaches to improve retention & comprehension and will improve trial compliance & performance."

Medical Monitor — Top 10 Biopharma
"The assessments for site staff enabled CRAs to focus on those elements of the study that needed additional attention during the SIV."

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