Cognika's Trial XL uses machine learning to analyze clinical trial data and provide insights to improve trial operations. It profiles investigators and sites, evaluates criteria that impact recruitment and outcomes, and ranks investigators. Case studies showed it identified criteria impacting recruitment, better accrual estimates, and new investigators, helping reduce delays. Trial XL leverages all past learning, applies analytics to extract insights, and accelerates decision making for clinical trials.

1. Trial XLTMAccelerate Decision Making for Clinical Trial Operations

2. Cognika’s Approach: Data driven unbiased analysisExhaustive LearningESP learning engine applied to all available dataUnbiased AnalysisModels purely emergent from dataModeling and SimulationPatient ProfilingCriteria Evaluation that have an effect on patient recruitmentSite Ranking Investigator selection

3. Case Study – Study of novel indication areaChallengeIndication area with limited prior knowledge.ApproachUsed Trial XL with analogous inclusion and exclusion criteria.ResultsA 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.

4. Case Study - Reducing enrollment delaysChallengeDelays in an important Phase III clinical trial in MS due to slower patient recruitment than expectedThe trial landscape was crowded by four other ongoing and competing trials in similar disease indicationApproachUsed Trial XL with expanded results to generate unknown and unexpected insightsResultsIn a three hour session the Cognika team was able to:locate three new investigators at academic medical centersprovide all information about efficient clinical trial sites that the sponsor had not previously considered.

5. Trial XLTMImproves Operational Success of Clinical TrialsLeverages all the learning from the pastApplies state of the art analytics to extract insightsAccelerates decision making Trial XLTMwww.TrialXL.comWeb based tool for Clinical Operations Improvement

6. Highly CustomizableData Sources IndexedProvenancePredictive AnalyticsVisualization Concept MapsDrill downsRelevance cut offsFalse Positive / NegativeExpand – CollapseReport OptionsMeta Analysis (Safety, Efficacy)

7. Initial Context

8. Summary of relevant clinical trials

9. Find Important factors influencing the outcomes

10. Unbiased Site and Investigator rankings

11. Profiles Generated in Real Time

12. Insights from past data

13. Created Using Cognika ESPTM Learning Engine24 Million +AbstractsUpdated WeeklyDaily Web Crawl80K + Clinical TrialsUpdated DailyTrial XLPublic Knowledge Base

14. Trial XLPublic Knowledge baseTrial XL Results: Insights for more efficient clinical operationsInsightsTrial sites and predicted enrollments. All relevant clinical trialsLocations, expert investigators virtual profiles.Protocol design parametersCritical parameters that affected the outcomes of past clinical trialsAdditional analytics subject to internal dataQuery / ResponseOver Internet

15. ProjectReportsCRODataTrial XLPublic Knowledge baseTrial XLEnterprise Knowledge baseCognikaESPInternalOperationsRecordsTrialResultsCDMSTrial XL Enterprise version combines internal data to ensure exhaustive learning from the past

16. Trial XLPublic Knowledge baseAdditional InsightsFactors influencing outcomesSuccess vs. FailureLessons learnedTrial XLEnterpriseKnowledge baseQuery / ResponseOver Intra / InternetCognikaESPTrial XL Enterprise Results: Insights for clinical program success

17. AdvantagesComprehensive Source DataUses all available dataReal time UpdateQuick AnswersUnique ESPTM AnalyticsPredictive & Diagnostic Media AgnosticContinuous LearningComplete Backup