Technology adoption in the clinical trial space has lagged other industries resulting in high cost / risk of new drug development and ongoing safety concerns of clinical trials. The focus of this presentation is to educate bio-pharma companies, data managers and CROs on technological advances in the clinical trial space.

1. 11
Reducing Risk, Cost & Duration
For a Successful Clinical Trial

2. 2
99 % of Clinical Trials Fail – Key Points of Failure
High Site Monitoring Costs
- 20 % of study budget
50 % data related
FDA rejection rate
Legacy Technologies &
Data Processing Methods
In-adequate Oversight
and Governance
Changing Regulatory
Requirements & Stds
Sub-Optimal Risk
Management

3. 3
Legacy Data Standardization Methodology – The Root Cause
Phase I, II, III
Clinical Trials
Manual Data
Standardization
& Analytics
5 Months Submission Lag
$1.5M standardization Costs
FDA
Submission Pkg
20 % of Study Cost
Site Monitoring
50 % Rejection rate
3 months approval delay
Data Silos
Across Trial(s)
Lost Revenue Lost Revenue
Q4, 2016 - FDA mandates clinical data submissions to comply with Clinical Data
Interchange Standards Consortium(CDISC) data Standards.
Risk Based Monitoring (RBM) reduces Site Monitoring Costs by ~ 25 % as per FDA

4. 4
Our Solution : Clinical Data Standardization & RBM Platform
Phase I, II, III
Clinical Trials
Automatic Data
Standardization
& Analytics
FDA
Submission
Package
• Our platform “Clindata Cloud” automatically generates FDA submission ready
CDISC datasets and analytics in real time, throughout the life of the Clinical Trial
• Clindata Cloud is the technology platform for Risk Based Monitoring

5. 5
Clindata Cloud – Clinical Data Standardization & RBM Platform
Data Security – Role based authorizations
and compliance with FISMA, PCI DSS, ISO
27001, SOC 1/SSAE 16/ISAE 3402, SOC
2, and HIPAA regulations.
Regulatory Compliance – Built-in
compliance with FDA CFR part-11, GMP,
GCDMP & CDISC and Audit Trials
Big Data Framework Massive data
processing @ blazing speeds ( One
million raw data study records converted
to SDTM datasets in 10 mins)
Private Cloud: Dynamically elastic, HA ,
Massive Scalability, Insulated and Secure
Clindata Cloud platform consolidates study
data from all sources and automatically
generates submission ready (eCTD Module
5) CDISC datasets and analytics in real
time through out the life of the study.

6. 6
Submission ready
standardized CDISC Datasets
Browser based Study Portal
Disparate Study data sources (SAS
XPT, SAS DAT, XLS, CSV, TSV..)
Consolidated Study Data
Real Time - Risk Based Monitoring (RBM)
Clinical Data Warehouse
CDISC Data Standardization
Engine
Predictive
Analytics
Engine
Risk Based
Monitoring
Engine
Study Data Portal & Mobility
Engine
CRO 1 CRO 2 CRO 3
FDA / EMA / PMDA Submission ready
Datasets, Analytics & RBM
Clindata Cloud: Clinical Data Standardization & RBM Platform

7. 7
Clindata Cloud: High Level Value Proposition
Consolidated & harmonized
view of study data from all
data sources
FDA Mandated CDISC
compliant datasets, in real
time from day 1 of the study

8. 8
Risk Based Monitoring (RBM) – Three Pillars

9. 9
RBM - Centralized Monitoring Pillar
Centralized Monitoring - Real Time
• Data Quality
 Completeness
 Integrity & Consistency
 Outliers & Errors
• Data Trends
 Unusual data distribution within and between study sites
 Fraud and data fabrication
 Severe Adverse Events

10. 10
Performance Metrics
 Subject screen failure rate
 Eligibility criteria violations
 Subject withdrawal rates
 Recruitment rates
 High frequency of eligibility violations
 Delays in reporting data
 Regulatory Non- noncompliance Incidents
 Severe Adverse Events & Deaths
 Others
RBM - CRO Oversight Pillar ( FDA 21 CFR Part 312 )

11. 11
 Good Clinical Practices - GCP
 Good Laboratory Practices - GLP
 Good Data Management Practices - GDMP
 Good Manufacturing Practices - GMP
 Good Pharmacovigilance Practices - GPvP
 Electronic Records – 21 CFR -Part 11
 HIPAA
RBM - Enterprise Wide Regulatory Compliance

12. 12
Real time data insights / Risk Mgmt. across all studies
1. Study compression by 8 Months & proactive risk management
2. Consolidated view of data across the study and cross study analytics
3. Enterprise wide platform for instantaneous regulatory safety / audit reporting
4. Single version of the truth across the enterprise
5. Study based SaaS pricing eliminates need for high IT capital expenditure
6. 25 % reduction in Site Monitoring costs 40 % reduction on data standardization
7. Code re-use reduces ongoing costs tremendously

13. 1313
Thank You !
info@clindatainc.com |
THANK YOU
www.clindatainc.com
Will be happy to hear from you !