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Optimus

Optimise Your Clinical Trials Safety Desk Procedures

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Our Services

Automatic Event Resolution Actions

Resolution actions in the system are triggered automatically, up-to-date policies and utilise pre configured reporting forms to ensure compliance

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Comprehensive Adverse Event Analysis

Tailored analytical recommendations based on data chosen by the sponsor, enhancing precision in studies.

AI Assisted Adverse Event Reporting

Accurate and complete event documentation through medically self-correcting features

Blogs

Enhancing Clinical Trial Safety: AI Assisted Event Reporting

In today's rapidly advancing healthcare landscape, optimizing clinical trials safety procedures is crucial to ensure the well-being of...

Optimizing Desk Procedures with Real-Time Notification Systems

In the fast-paced world of clinical trials, optimizing desk procedures is crucial for ensuring the safety and success of trials. One key...

AI-Driven Event Processing: Improving Clinical Trials Efficiency

In the ever-evolving landscape of healthcare, the utilization of artificial intelligence (AI) technology has become increasingly...

Knowledge Base

Alexa Young, CA

The collection, reporting and analysis of AE data in clinical trials is inconsistent and RCTs as a source of safety data are underused. Implementation of standard reporting practices could enable a more accurate synthesis of safety data and development of guidance for statistical methodology to assess causality of AEs could facilitate better statistical practice.

BMJ Open - Analysis and reporting of adverse events in randomised controlled trials: a review

Morgan James, NY

We identified several pitfalls in adverse effects reporting in clinical trials. These include heterogeneous disease definitions, reporting thresholds, and incomplete reporting. Trial bias may have great impact on risk assessments in systematic reviews and meta-analyses.

BCPT - Biases in reporting of adverse effects in clinical trials, and potential impact on safety assessments in systematic reviews and therapy guidelines

Lisa Driver, MI

To improve drug safety assessments, trials should include predefined monitoring for predictable adverse events and ensure thorough follow-up, while innovative methods are explored.