Trial XLTM

Accelerate Decision Makingfor Clinical Trial Operations

Cognika’s Approach: Data driven unbiased analysis

• Exhaustive Learning

– ESP learning engine applied to all available data

• Unbiased Analysis

– Models purely emergent from data

• Modeling and Simulation

– Patient Profiling

– Criteria Evaluation that have an effect on patient recruitment

– Site Ranking

– Investigator selection

Case Study – Study of novel indication area

• Challenge

– Indication area with limited prior knowledge.

• Approach

– Used Trial XL with analogous inclusion and exclusion criteria.

• Results

– A targeted subset of inclusion criteria that has most impact on the recruitment rate and outcomes.

– Better estimates of patient accrual rates using proprietary simulation and modeling techniques.

– Improved recruitment program based on the insights generated by the Cognika team.

Case Study - Reducing enrollment delays

• Challenge

– Delays in an important Phase III clinical trial in MS due to slower patient recruitment than expected

– The trial landscape was crowded by four other ongoing and competing trials in similar disease indication

• Approach

– Used Trial XL with expanded results to generate unknown and unexpected insights

• Results

In a three hour session the Cognika team was able to:

– locate three new investigators at academic medical centers

– provide all information about efficient clinical trial sites that the sponsor had not previously considered.

Trial XLTM

Improves Operational Success of Clinical Trials

• Leverages all the learning from the past

• Applies state of the art analytics to extract insights

• Accelerates decision making

Trial XLTM

www.TrialXL.comWeb based tool for Clinical Operations

Improvement

Highly Customizable

• Data Sources Indexed

– Provenance

– Predictive Analytics

• Visualization

– Concept Maps

– Drill downs

• Relevance cut offs

– False Positive / Negative

– Expand – Collapse

• Report Options

• Meta Analysis (Safety, Efficacy)

Initial Context

Summary of relevant clinical trials

Find Important factors influencing the outcomes

Unbiased Site and Investigator rankings

Profiles Generated in Real Time

Insights from past data

Created Using Cognika ESPTM Learning Engine

Trial XL

Public

Knowledge Base

80K + Clinical TrialsUpdated Daily

24 Million +AbstractsUpdated Weekly

Daily Web Crawl

Trial XL

Public

Knowledge base

Trial XL Results: Insights for more efficient clinical operations

Query / Response

Over Internet

Insights

• Trial sites and predicted enrollments.

• All relevant clinical trials

• Locations, expert investigators virtual profiles.

• Protocol design parameters

• Critical parameters that affected the outcomes of past clinical trials

• Additional analytics subject to internal data

Cognika

ESP

Internal

Operations

RecordsProject

Reports

CRO

Data

Trial

ResultsCDMS

Trial XL

Enterprise

Knowledge base

Trial XL

Public

Knowledge base

Trial XL Enterprise version combines internal data to ensure exhaustive learning from the past

Cognika

ESPTrial XL

Enterprise

Knowledge base

Trial XL

Public

Knowledge base

Query / Response

Over Intra / Internet

Trial XL Enterprise Results: Insights for clinical program success

Additional Insights

• Factors influencing outcomes

– Success vs. Failure

• Lessons learned

Advantages

• Comprehensive Source Data– Uses all available data– Real time Update

• Quick Answers– Unique ESPTM Analytics

• Predictive & Diagnostic • Media Agnostic• Continuous Learning• Complete Backup