SCOPE 2018 - Clinical Data Analytics – A Solutions Approach in the Cloud

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Karim Damji, SVP at Saama, and Amit Gulwadi, Executive Director at Celgene, discuss how Celgene leveraged new technologies to improve data quality, evidence generation, and time-to-insights.

Dados e análise

Copyright © 2018, Saama Technologies
Clinical Data Analytics –
A Solutions approach in the Cloud
February, 2018

2
Copyright © 2018, Saama Technologies
Karim Damji
SVP – Saama (Head of Clinical
Analytic Products)
Amit Gulwadi
Executive Director – Celgene (Clinical
Trial Planning and Analytics)

3
Copyright © 2018, Saama Technologies
Agenda
Business Problem
1
Solution
2
Solution Capabilities
3
Business Benefits
4
Partnership
5

4
Copyright © 2018, Saama Technologies
We had a Problem
We were GROWING, so was our DATA.
We were running into a huge problem “SCALABILITY”
We started off with a local problem
We soon realized we had a global problem
Each geography had built their own local set of clinical operational processes, CTMS systems,
Data Definitions and Metrics ..data collection procedures and data management standards
Multiple different systems

5
Copyright © 2018, Saama Technologies
1 Week
10 days
2 days
Resulting in Inconsistencies and Trust
How are MM
studies doing?
Great
Not so Great
Let me get
back to you

6
Copyright © 2018, Saama Technologies
My State: Preparing for Global ELT meeting
CTMS saying
something else
CRO’s saying
something else
I ran the reports
myself
A completely new
answer
What do I report back ?
We Need CHANGE

7
Copyright © 2018, Saama Technologies
We had to CHANGE
Medidata CTMS, RaveX
(Done Globally)
Business
Processes
Business
Processes
Business
Processes

8
Copyright © 2018, Saama Technologies
Data had to be CENTRALIZED
Big Data Clinical Analytics Solution
in AWS – by Saama (VeRA)
VeRA means TRUTHTRUTH has TRUSTTRUTH has SPEEDTRUTH had
SCALABILITY
Consistent
Clinical Ops
Data
Clinical Ops
Data
Clinical Ops
Data

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Copyright © 2018, Saama Technologies
Data from all CRO’s had to be standardized & centralized too
Big Data Clinical Analytics Solution
in AWS – by Saama (VeRA)
Consistent
CRO 1
CRO 2
CRO 3

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Copyright © 2018, Saama Technologies
User Personas
Study Manager
What is the screen failure rate for CK
–XXX-YZ ?
Global Clinical Operations Head
Across therapeutic areas how many studies are at risk ?
Franchise Head
Are we above budget for Multiple
Myeloma studies

11
Copyright © 2018, Saama Technologies
User Experience at Portfolio, Study, Countries had to be Standardized

12
Copyright © 2018, Saama Technologies
User Experience at Portfolio, Region, Country, Study had to be Standardized

13
Copyright © 2018, Saama Technologies
Today
Everyone has a standardized, consistent view of their
portfolio, region, country and studies
Teams start their day within VeRA, insights are INSTANT
Study Managers start
their day in VeRA
ELT has the same view
as Regional heads
Metrics are standardized
across all regions, studies

14
Copyright © 2018, Saama Technologies
Nuts ‘n Bolts
A scalable engine to collect, standardize and
transform Clinical data

15
Copyright © 2018, Saama Technologies
Centralize (and contextualize) Data in Flight

16
Copyright © 2018, Saama Technologies
Workflows had to be Centralized, Simplified and Self Service

17
Copyright © 2018, Saama Technologies
Data Quality had to be Managed within the Solution

18
Copyright © 2018, Saama Technologies
The Future
Speak to Me (Smart) and Tell us the Future (Deep Learning)

19
Copyright © 2018, Saama Technologies
2011 – CNN, TechCrunch interview with Mary Meeker:
She believes that voice input is the “new QWERTY”
UX CX
A way forward with your analytics

20
Copyright © 2018, Saama Technologies
Introducing “Smart Assistant” for Clinical Operations

21
Copyright © 2018, Saama Technologies
Benefits

22
Copyright © 2018, Saama Technologies
Before - After
Before
Access
Source
Efficiency
Trust
Action Intuition, Limited to
Study Managers
2 Weeks to Insights
Multiple Disparate Sets of Data
and Reports
Study Managers have Access to
Study Data using Spreadsheets
Rely on CRO’s for Study Insights
After
Consistent Fact-based
Significant Reduction in Time to
Convert Data into Insights (Daily
Now)
Single Source of Truth
Accessible to Executive
Leadership
Entire Organization has Access
to Study Performance Metrics
Self Service Exploratory Access
to Study Performance Insights

23
Copyright © 2018, Saama Technologies
Partnership

24
Copyright © 2018, Saama Technologies
The Partnership between Business Acumen and Insights
Business Problem
Data
Visions
Business Solution
Novel Data Management
Consistent Business Insights

25
Copyright © 2018, Saama Technologies
Visit us in booth 316 and join us tonight
Continuing the Conversation

26
Copyright © 2018, Saama Technologies
THANK YOU

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4. 4 Copyright © 2018, Saama Technologies We had a Problem We were GROWING, so was our DATA. We were running into a huge problem “SCALABILITY” We started off with a local problem We soon realized we had a global problem Each geography had built their own local set of clinical operational processes, CTMS systems, Data Definitions and Metrics ..data collection procedures and data management standards Multiple different systems

6. 6 Copyright © 2018, Saama Technologies My State: Preparing for Global ELT meeting CTMS saying something else CRO’s saying something else I ran the reports myself A completely new answer What do I report back ? We Need CHANGE

8. 8 Copyright © 2018, Saama Technologies Data had to be CENTRALIZED Big Data Clinical Analytics Solution in AWS – by Saama (VeRA) VeRA means TRUTHTRUTH has TRUSTTRUTH has SPEEDTRUTH had SCALABILITY Consistent Clinical Ops Data Clinical Ops Data Clinical Ops Data

10. 10 Copyright © 2018, Saama Technologies User Personas Study Manager What is the screen failure rate for CK –XXX-YZ ? Global Clinical Operations Head Across therapeutic areas how many studies are at risk ? Franchise Head Are we above budget for Multiple Myeloma studies

13. 13 Copyright © 2018, Saama Technologies Today Everyone has a standardized, consistent view of their portfolio, region, country and studies Teams start their day within VeRA, insights are INSTANT Study Managers start their day in VeRA ELT has the same view as Regional heads Metrics are standardized across all regions, studies

22. 22 Copyright © 2018, Saama Technologies Before - After Before Access Source Efficiency Trust Action Intuition, Limited to Study Managers 2 Weeks to Insights Multiple Disparate Sets of Data and Reports Study Managers have Access to Study Data using Spreadsheets Rely on CRO’s for Study Insights After Consistent Fact-based Significant Reduction in Time to Convert Data into Insights (Daily Now) Single Source of Truth Accessible to Executive Leadership Entire Organization has Access to Study Performance Metrics Self Service Exploratory Access to Study Performance Insights

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