Data Analysis & VisualizationFrom Static to Interactive

Artem Zharkov & Nav Coelho

Background

Background Objective: Enhanced understanding of clinical trial data to enable better decision making for Safety Science

SPA Solution: Core Safety Visualization Templates - Add customized new interface to existing data to enable interactive exploration of the data

Result:

★ Visual interactive display of safety data proves to be an effective way to analyze and communicate findings.

★ Shorter response times; speed for decision making★ Empowering colleagues to gain better understanding of the data

Enhanced Understanding of Data, Reduced Workload

●

●

●

●

●

●

What is Core Safety Visualizations (CoreSV)?

Safety and Biometrics: Smarter Together ★ Improved information flow and analytics for safety data★ Standardized suite with safety-focused data (i.e. adverse events, laboratory

values, concomitant medications)★ Consistent with analysis criteria used for clinical safety reporting purposes★ Able to be further customized for molecule- or study-specific needs★ Provide controlled access to reports via web browser, no additional software

is needed

CoreSV Functionality: High-level overview

What Are Common Adverse Events?

What is the Trend for Laboratory Tests in Patients?

Patient Example: Clinical Course with Neutropenia (Low White Blood Cell Count)

Confounding Concomitant Medications

Implementation ChallengesChallenge Solution

No universal solution, needs customization to adapt to study/molecule requirements

★ Set of standard templates (80%) ★ Customized outputs (20%)★ Continuous evolvement of standard templates

Technical proficiency of teams ★ Introductory + in depth Spotfire / CoreSV trainings★ Statistical programmer support readily available★ Leveraging functional Subject Matter Experts in Safety

Science

Global implementation leading to geographical differences

★ Different roll-out strategy and timing for North American and European molecule teams

★ Global alignment in CoreSV strategy

Mindset change, change of data ownership ★ Tool roll-out linked to project milestones with advance technical training available

★ Targeted training and experience sharing group sessions by Therapeutic Area within Safety Science

Learnings ★ Seizing the opportunity★ Managing rollouts in a large organization★ Collaborative model★ Shifting mindsets★ Tackling technical uptake ★ Importance of engaging stakeholders (not

directly involved)★ Thinking about the future