1. Dramatic Change in Data Review Handling with Analytical Tools

2. 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

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

4. 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

5. New Digital World

7. 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.

9. 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

10. 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

11. Power of Analytics

12. Thanks !!!