Saama and Pharmacyclics Present at CTI: Clinical Data Analytics – A Solutions approach in the Cloud

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This document discusses a clinical data analytics solution implemented in the cloud by Saama Technologies to address the challenges of centralized access and reporting across dispersed clinical operations for a pharmaceutical company. The key points are: 1. The company previously had isolated data silos across different clinical systems which made comprehensive reporting difficult and time-consuming. 2. Saama implemented a centralized clinical data analytics platform in AWS that standardized data ingestion and metrics across studies to provide integrated insights. 3. This has improved access to insights, reduced reporting time from weeks to instantaneous, and established a single source of truth for study oversight.

Données & analyses

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

2
Copyright © 2018, Saama Technologies
Nikhil Gopinath
Sr. Product Manager,
Saama Technologies
Pawan Parihar
Senior Director, Ent Apps & Analytics
Pharmacyclics (An AbbVie Company)

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

4
Copyright © 2018, Saama Technologies
We had a Challenge
We started off with autonomous data management
within each clinical operations team.
Globally Expanding Clinical Operations
We later realized that with expansion of clinical operations, it became
challenging to get a quick and integrated view of the data from the clinical
operations teams.
The existing functional data silos made it difficult to access and get a
comprehensive view of the operational data.
Multiple different systems

5
Copyright © 2018, Saama Technologies
1 Week
10 days
2 days
Manual and Effort Intensive Data Reporting
How are our
studies doing?
Great
Not so Great
Let me get
back to you

6
Copyright © 2018, Saama Technologies
Data had to be CENTRALIZED and STANDARDIZED
Consistent
Big Data Clinical Analytics Solution
in AWS – by Saama (TMA)
CTMS
Protocol
Deviation Data
(CROs)
Screening &
Enrollment
( IRT
Systems)
Study
Milestones
Clinical
Quality Data

7
Copyright © 2018, Saama Technologies
User Experience at Portfolio, Study, Countries had to be Standardized

8
Copyright © 2018, Saama Technologies
User Experience at Portfolio, Region, Country, Study had to be Standardized

9
Copyright © 2018, Saama Technologies
User Experience at Portfolio, Region, Country, Study had to be Standardized

10
Copyright © 2018, Saama Technologies
Today
Everyone has a standardized, consistent view of their
portfolio, region, country and studies
Teams start their day within TMA, insights are INSTANT
Clinical Operations has
quick access to the
comprehensive view of
the Global Study
Portfolio.
Clinical Trial Manages
have the same view as
Clinical Operations
Executives.
Metrics are standardized
across all regions, studies.

11
Copyright © 2018, Saama Technologies
Nuts ‘n Bolts
A scalable engine to collect, standardize and
transform Clinical Data

12
Copyright © 2018, Saama Technologies
Centralize (and contextualize) Data in Flight
Ingest &
Rules Apply
Standardize
(CODM)
Apply
Metrics
Analytic
Ready Data
Analytic
Ready Data
Covert
ADaM
Standardize
SDTM
Ingest &
Rules Apply
CTMS
Project
Management
CRO
EDC
Labs
Biomarker
KPI/Metrics Pipeline
Subject Analytics Pipeline
Clinical Operations
Clinical Sciences

13
Copyright © 2018, Saama Technologies
Workflows had to be Centralized, Simplified and Self Service

14
Copyright © 2018, Saama Technologies
Data Quality had to be Managed within the Solution

15
Copyright © 2018, Saama Technologies
The Future
Speak to Me (Smart) and Tell us the Future (Deep Learning)

16
Copyright © 2018, Saama Technologies
Introducing “Smart Assistant” for Clinical Operations

17
Copyright © 2018, Saama Technologies
Benefits

18
Copyright © 2018, Saama Technologies
Before - After
Before
Access
Efficiency
Trust
Action Siloed view of data from
individual data sources
2 Weeks to Insights
Multiple Disparate Sets of Data
and Reports
Study Managers have Access to
Study Data using Spreadsheets
After
Integrated view of data using
Trial Management Analytics
Platform
Significant Reduction in Time to
Convert Data into Insights
(almost instantaneous)
Single Source of Truth
Accessible to Executive
Leadership
Approved users have quick
access to Trial Management
Analytics dashboards

19
Copyright © 2018, Saama Technologies
Partnership

20
Copyright © 2018, Saama Technologies
The Partnership between Business Acumen and Insights
Business Challenge
Data
Visions
Business Solution
Novel Data Management
Consistent Business Insights

21
Copyright © 2018, Saama Technologies
Thank You

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4. 4 Copyright © 2018, Saama Technologies We had a Challenge We started off with autonomous data management within each clinical operations team. Globally Expanding Clinical Operations We later realized that with expansion of clinical operations, it became challenging to get a quick and integrated view of the data from the clinical operations teams. The existing functional data silos made it difficult to access and get a comprehensive view of the operational data. Multiple different systems

6. 6 Copyright © 2018, Saama Technologies Data had to be CENTRALIZED and STANDARDIZED Consistent Big Data Clinical Analytics Solution in AWS – by Saama (TMA) CTMS Protocol Deviation Data (CROs) Screening & Enrollment ( IRT Systems) Study Milestones Clinical Quality Data

10. 10 Copyright © 2018, Saama Technologies Today Everyone has a standardized, consistent view of their portfolio, region, country and studies Teams start their day within TMA, insights are INSTANT Clinical Operations has quick access to the comprehensive view of the Global Study Portfolio. Clinical Trial Manages have the same view as Clinical Operations Executives. Metrics are standardized across all regions, studies.

12. 12 Copyright © 2018, Saama Technologies Centralize (and contextualize) Data in Flight Ingest & Rules Apply Standardize (CODM) Apply Metrics Analytic Ready Data Analytic Ready Data Covert ADaM Standardize SDTM Ingest & Rules Apply CTMS Project Management CRO EDC Labs Biomarker KPI/Metrics Pipeline Subject Analytics Pipeline Clinical Operations Clinical Sciences

18. 18 Copyright © 2018, Saama Technologies Before - After Before Access Efficiency Trust Action Siloed view of data from individual data sources 2 Weeks to Insights Multiple Disparate Sets of Data and Reports Study Managers have Access to Study Data using Spreadsheets After Integrated view of data using Trial Management Analytics Platform Significant Reduction in Time to Convert Data into Insights (almost instantaneous) Single Source of Truth Accessible to Executive Leadership Approved users have quick access to Trial Management Analytics dashboards

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