Empiric One

Solutions

By Customer Type

Pharma & Biotech

Digital Health & Medtech

Health Service Organisations

Academic Consortia

By Use Case

Rare Diseases & Rare Cancers

Value-Based Healthcare

Condition-specific Solutions

About

About Us Our Impact Theory of Change Team & Advisors

One Software Platform, Nine AutomationSolutions

Empiric One is an integrated suite of workflow automation tools designed to make clinical trials smarter and faster.

Module 1: Ready

Assess readiness, identify gaps, and manage risk.

Features:

Perform automated gap analysis to identify readiness shortfalls
Automate generation of risk management plans based on identified gaps.
Calculate readiness scores to determine trial initiation preparedness.

Benefits:

Accelerate trial initiation by quickly identifying and addressing readiness issues.
Reduce risk with comprehensive preparation before trial commencement.
Gain clear oversight with visibility into readiness metrics.

Module 2: Specify

Generate data-first trial design specifications.

Features:

Automatically generate design specifications tailored to your trial objectives.
Develop data-first strategies that align with your trial design.
Automatically generate data complexity ratings, enabling smarter trial design.

Benefits:

Enhance design precision by automating specification creation.
Ensure data alignment with trial objectives from the outset.
Enable smarter trial design by understanding and managing data complexity.

Module 3: Simulate

Perform statistical simulations to optimise trial designs.

Features:

Run advanced statistical models to optimise trial designs.
Evaluate multiple trial designs through scenario analysis.
Make data-driven adjustments based on simulation outcomes.

Benefits:

Increase trial success by identifying the most effective design.
Reduce costs by avoiding suboptimal trial configurations.
Make proactive adjustments to trial design before implementation.

Module 4: Collect

Design intelligent, dynamic Case Report Forms.

Features:

Automatically design CRFs based on your trial requirements.
Use dynamic form logic for intelligent data capture.
Integrate with EDC systems for seamless data entry.

Benefits:

Improve data accuracy with intelligent, dynamic CRFs.
Streamline data collection through automated form design.
Reduce data entry errors, enhancing trial data quality.

Module 5: Comply

Automate ethics, GCP compliance, and data privacy.

Features:

Automate the preparation of ethics submissions.
Monitor and report GCP compliance effectively.
Manage data privacy compliance, including region specific requirements.

Benefits:

Ensure regulatory compliance with minimal manual effort.
Speed up ethics approvals through automated submission generation.
Protect patient data by maintaining high integrity privacy standards.

Module 6: Analyse

Orchestrate interim data analysis to speed up trial adjustments.

Features:

Execute interim analysis submissions automatically.
Orchestrate data flow to and from statistical scientists for streamlined analysis.
Rapidly adapt analysis plans based on emerging data.

Benefits:

Facilitate timely decisions through efficient interim analysis.
Enhance collaboration by integrating external statistical expertise.
Improve trial outcomes by enabling adaptive responses to data trends.

Module 7: Alert

Manage adverse events and safety data seamlessly.

Features:

Automate the management of adverse events.
Monitor safety in real-time with dynamic dashboards.
Identify and automate external reporting.

Benefits:

Enhance patient safety with real-time monitoring and reporting.
Reduce manual workload in managing safety data.
Ensure regulatory compliance with streamlined reporting processes.

Module 8: Audit

Track audit trails, record decisions, and control documents.

Features:

Manage comprehensive audit trails with automated logging.
Track decision logs to record key trial management decisions.
Control document versions with a robust management system.

Benefits:

Enhance transparency with detailed audit trails.
Improve compliance by tracking all trial-related decisions.
Streamline document management with robust version control.

Module 9: Report

Generate reports and perform analysis to gain insight.

Features:

Generate custom reports with automated scheduling.
Conduct real-time data analysis across multiple trial metrics.
Use interactive dashboards to visualise trial progress.

Benefits:

Inform stakeholders with clear, actionable insights.
Improve trial management through comprehensive reporting.
Enable real-time adjustments by providing timely data analysis.

Solutions

By Customer Type

Pharma & Biotech Digital Health & Medtech Health Service Organisations Academic Consortia

By Use Case

Rare Diseases & Rare Cancers Mental Health Value-Based Healthcare Condition-specific Solutions

About

About Us Our Impact
Theory of Change
Team & Advisors

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