Dramatic Change in Data Review Handling with Analytical Tools

Topics for Discussion Magic of Analytics Intro & History New Digital World Types of Analytics Analytics in Health Care Challenges in Healthcare Analytics Powering healthcare transformation Data Review & tools Advantages 2

Magic of Analytics Discovery Interpretation Statistical Modeling Insight Meaningful Patterns Analytical Application Smart Decision Making

History Of Analytics 4 RDB Data Mining Data warehouse Tabulating Machine Computers RDB Data warehouse Data Mining Google Web Search Big Data Cloud AI BI

New Digital World

Analytics in Clinical trails Compound Selection Site Selection Site Monitoring Patient recruitment Patient retention EDC Preparation Cleansing Early monitoring Safety and Efficacy review Submission Readiness RBMS (Risk based monitoring system) ICH GCP requires: 2.10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification. 5.1.1 The sponsor is responsible …… and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). 5.1.3 Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.

Clinical Flow and Data review TOOLS Excel SAS JMP R J-review Spotfire MATLAB Medictiv Pyton Planning Development Site Selection Patient Enrollment Data Collection Design Review Site Monitoring & Patient retention Early Medical Monitoring Data Analysis Data Standardization Data Validation Data entry Data Standardization and Submission readiness Cleansing Safety and Efficacy review Reports Development Review and Finalization Agency Submission

Advantages of Analytics in data review Automation of reports development Adequate & Accurate data collection Compound Selection Result based amendment of trial flow Auto Query the sites Early Prediction of results Site, Patient & Lab data management Direct Inference reports Site Selection

Power of Analytics

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