11

Reducing Risk, Cost & Duration

For a Successful Clinical Trial

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

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

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

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

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

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

Risk Based Monitoring (RBM) – Three Pillars

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

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

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

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

1313

Thank You !

info@clindatainc.com |

THANK YOU

www.clindatainc.com

Will be happy to hear from you !