CONFIDENCEAT EVERY TURNCONFIDENCEAT EVERY TURN
Prakriteswar Santikary, PhDVice President and Global Chief Data Officer
ERT’S MODERN DATA AND AI PLATFORM AT SCALE IN THE CLOUD – A PERSPECTIVE FROM DATA SECURITY, PRIVACY AND PROTECTION
ABOUT ERT
│ © Copyright ERT 20182
Founded in 1977; privately held
Supporting Pharmacos, Biotechs & CROs around the world
Operations in 12 countries
2500+ employeesMINIMIZING RISK &
UNCERTAINTY, SO
YOU CAN MOVE
AHEAD QUICKLY
WITH CONFIDENCE
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GLOBAL REACH & EXPERIENCE
│ © Copyright ERT 20183
Boston, MA
Boulder, CO
Bridgewater, NJ
Cleveland, OH
Philadelphia, PA
Raleigh, NC
Rochester, NY
Scotts Valley, CA
St. Louis, MO
Brussels, BE
Estenfeld, GER
Geneva
Nottingham, UK
Peterborough, UK
Tokyo, JP
>50%
new drug
approvals
trials
sites spanning 114
languages & 106
countries
of all FDA
approvals over
the past 4 years
550+
13K+
230K+
patients3M+
SUPPORT FOR…
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CLINICAL TRIAL INDUSTRY CHALLENGES
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Complexity In clinical
trials
§ Multiple data sources§ Multiple devices§ Multiple data types§ Multiple vendors§ Patient recruitment§ Site qualification
§ real time data ingestion at scale§ Real time data processing§ Data siloes – lack of governance§ Difficult to identify issues and
resolve them in real time§ Lack of visibility into actions
being taken to address issues
§ Patient compliance§ Site compliance§ Query resolution§ Visit compliance§ Regulatory compliance
§ Oversight of trials and sites§ Oversight of vendors§ Oversight of systems§ Monitoring of trial risks§ Data security and privacy
Data Collection
Oversight and Monitoring
Data Processing and Access01 02
0304 Data Quality
SYSTEM DISPARITY IS GROWING WITH SPECIALIZATION
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MORE SYSTEMS ARE INTRODUCED IN CLINICAL RESEARCH EACH YEAR
EDC
CTMS
IVR
mHealth
Labs
Images
Esta
blis
hed
eClin
ical
Sys
tem
s
eCOA
mHEALTH
PATIENT IDENTIFICATION
HOME MONITORING EMR
PATIENT ENGAGEMENT
TRIALS GETTING MORE COMPLEX
│ © Copyright ERT 20186
Increasing interest in building protocols based on real-time
outcomes; mitigating risk of protocol change
mid trial
Increase in Complex Trials
Continued move to a single Cloud-
based platform as trial methodology of choice powered by
data. Allows for agility and speed to
market.
Key
Insi
ght
Impl
icat
ions
Technology advancements driving highly individualized
patient therapeutics administration.
Advancement of Precision Medicine
Ability to do smaller targeted trials
improving outcomes based on
lifestyle, environment and genetic makeup.
Shift in more active patient engagement - improving access
to trials via mHealth, virtual
trials and focusing on outcomes.
Patient Centricity
Further investment in clinical trials that meet patient needs – less burdensome, increased diversity
and better outcomes.
An explosion of data from
wearables, genomics, social,
imaging, etc. –driving advances in data interaction and
visualization.
More Big Data & AI Modeling
Need to standardize data
sets - mine previous data sets, and better ingest,
analyze and manager larger, more complex
data.
The promise of Blockchain to help
concerns over privacy, data sharing and
reproducibility.
Blockchain
Increased investment in
blockchain technology to improve data
security –competitive
differentiation.
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VOLUME
VELOCITY
VARIETY
VERACITY
EXPONENTIAL DATA GROWTH IN LIFE SCIENCES
│ © Copyright ERT 20187
Clinical, compliance, medical, RWE/commercial and actimetry
Ability to gain insight from aligned data sets
Digitization has increased the speed of information
More types along with more endpoints
Organizations must implement scalable infrastructures to deal with increased data volumes
Leading customer experiences require contemporary insights that can be acted on
Flexible data models are required to integrate customer information
Need to enable multiple user groups with consumable insights
Implications
RECENT SECURITY TRENDS / EVENTS**Pharma expanding security / cyber-security organizations:
● Amgen - 88 open security roles● Eli Lily - 11 open security roles● Pfizer - 35 open security roles● Merck - 22 open security roles● Sanofi - 11 open security roles
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Pharma & Other cyber security incidents:
● Charles River Labs - data breach - April 2019● Merck / NHS (UK) - zero-day virus attack - June
2017● Qwest Diagnostics – Data Breach – 11.9 M patient
data compromised ( PII, Financial Data) - June 2019● *The average cost of a security attack on a company
is $2.4 M● *The average cost in time of a security attack is 50
days● *From 2016 to 2017 there was an 22.7 percentage
increase in cybersecurity costs● *Malware and web-based attacks are the two most
costly attack types — companies spent an average of US $2.4M in defense.
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CONDUCTING CLINICAL TRIALS COMES WITH UNCERTAINTY AND RISK
│ © Copyright ERT 20189
TRIALSTART
TRIALEND
<10%OF
TRIALS END ON TIME
48%OF SITES
UNDER-ENROLL SUBJECTS
5-12SYSTEMS
PER GLOBALSTUDY
58%INCREASEIN SITES
PER TRIAL
71%INCREASE IN
AVERAGE ENDPOINTS
30%AVG PATIENT
DROPOUT RATE
GROWING TRIAL COMPLEXITY ADDS TO DECLINING PERFORMANCE
High administrative burden to extract and re-enter data Into other systems Difficult to filter out noise to identify real issues that require attentionMore effort is spent confirming the accuracy of data than interpreting it for decision-makingCost overrun and delay to time-to-market
Our customers are crying out for help –“Please simplify the complex!”
CLINICAL TRIAL TEAMS ARE DROWNING IN DATA
WAVES OF INFORMATION THAT AREN’T ACTIONABLE
│ © Copyright ERT 201810
TRANSFORMING DATA INTO STRATEGIC BUSINESS ASSETS USING MODERN, SECURE, CLOUD-BASED DATA PLATFORM
SCALEMODERN TECH STACK GOVERNED
REAL TIME REPORTING ANALYTICS AND DATA SCIENCE
│ © Copyright ERT 201811
Data platform architecture at a glance• Lambda architecture (batch and speed layers)• Modular microservices architecture• Serverless Computing• Master data management/data governance• Data ingestion at scale• Adapters and connectors for third party data
integration• Modern data visualization architecture
Customer benefits at a glance• Enables real time decision making• Enables self-service reporting and analytics• Enables data monetization;• Reduces complexity and improves quality• Enables Data-driven decision making• Enable Speed to market of life-saving drugs• Centralizes risk and performance management of trials• Enables cost savings & operational efficiencies• Enables AI and ML capabilities – anticipatory oversight
CLOUD BASED
ERT’ AI and ML Approach
ERT’S DATA SECURITY APPROACH
│ © Copyright ERT 2017 13
Assure data security & compliance as required by regulatory
Build security in requirements (PLC) and development (DLC) of ERT products & services.
Improve ERT’s security awareness
Unify ERT’s security posture across all LOBs
Achieve industry-recognized security
management certification
Establish standard security controls and audit evidence
SecureERT
▪ Establish Sponsor confidence in ERT security controls to protect clincial data
▪ Reduce applications security vulnerabilities
▪ Standardize ERT security posture across all applications and hosting facilities
▪ Reduce ERT internal security vulnerabilities
ERT PLATFORM SECURITY OPERATION
DEFENSE (SECURITY) IN DEPTH
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Security Enhancement Program to address ERT Security Posture Gaps and associate Security Risks.
Security in Depth is an information assurance (IA) methodology that implements security controls in layers.
KEY TAKEAWAYS FROM TODAY’S DISCUSSION
│ © Copyri
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Data Governance
To unleash the potential of data - Master data management, data quality, data profiling, data policies and standards – fosters cross-organizational collaboration
Modern Data Foundation
Ingest any data of any type of any velocityData processing at scale, easy data access, provides self service, provides advanced analytics capabilities including AI and ML
Data security and access Governed data store, transparency, regulatory compliance,
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