HySynth Clinical Data Repository

HySynth BioTechnologies
Robert V Chandran Tower
#149, Velachery ‐ Tambaram Main Road,
Chennai, Tamilnadu, INDIA
biometrics@hysynth.com
HySynth’s Clinical Data Repository

Pharmacovigilance
Bio‐Similar and Biomarker Research
Life Science Technology
Clinical Data Management

confidential
Life Science
Technologies
Implementation &
Customization
Clinical Data
Repository
Clinical
Development
Analytics
Upgradation Migration
Integration
Study Setup

confidential
We provide,
Business case development and cost analysis
Requirements and design management
Best practice analysis and recommendations
Installation and configuration
Oracle CDA and LSH pilots and proofs of concept
Hosting
Oracle CDA and LSH implementation
CDA and LSH validation
CDA and LSH training
CDA and LSH extension development
Life Science Technology (LST)

LST on the following applications
Argus Safety Suite
Oracle Clinical / Remote Data Capture (RDC) /
Thesaurus Management System (TMS)
Oracle Inform EDC / Central Designer / Central Coding
Life Sciences Data Hub (LSH)
Oracle Data Management Workbench (DMW)
Oracle Clinical Development Analytics (CDA)
Adverse Event Reporting System (AERS)
SAS
Life Science Technology (LST)

Need for LST
Key issues faced by the industry include:
Non‐uniform sets of data from EDC, CRO, Purchased Trial.
(Patient Data, Metadata, Financial Data)
Data not integrated between Clinical Trial & Clinical Safety
Performance Metrics – delay in getting
Safety Signal Detection not effective on insufficient & poor quality of data.
Double Data Entry
Reporting is mostly manual, time consuming & costly.
Manual reconciliation of data
High down time & maintenance window.

Ability to pool data across phases
Review safety data across products
Analyze data trends using a review tool
Use data mining for targeted populations
Allow project teams to oversee and manage clinical trials through a
single user interface with role‐based access
Get rapid, near real‐time access to data on clinicians' desktops
Respond to regulatory authority questions quickly and confidently
Use data to make go/no‐go decisions in product development
Look for data trends on marketed products for best practices in
patient care
Provide access to investors and clinical development partners to
make business decisions
Need for LST

confidential
Increase adoption of CDISC Standards
• SDTM
• CDASH
• New CDISC Standards (Therapeutic area specific)
Clinical data integration
• eCRFs
• ePRO
• IVRS
• CTMS
• Central Lab
Increase use of
• Clinical Data Repository (CDR)
• Clinical Development Analytics (CDA)
LST Emerging Scenario

• CDR is used for storing, integrating ,managing and reporting on clinical
studies.
• It enables pooling of clinical and nonclinical data from multiple sources into
a single environment.
• Better regulatory compliance with comprehensive security, an audit trail,
and traceability
• More‐informed decision‐making through pooling and analysis of clinical
and nonclinical data
• CDR has been developed to revolutionize ability to:
• Address complex health authority questions quickly and completely
• Produce CDISC compliant submissions
• Review safety data in real‐time, mine our overall database for
scientific and commercial queries
Clinical Data Repository (CDR)

confidential
Clinical Data Repository (CDR)

CDR architecture
The CDR framework can be effectively built using the
appropriate platform
Anticipating the movement of the industry and its
governing regulatory bodies toward standards
(CDISC data models)
Clinical data analysis, the FDA standard for electronic
submissions;
CDR assure research data must be accurate, consistent
and reliable

Data
Sources
Staging
Layer
Data
Warehouse
Layer
Reporting
Layer
CDR architecture

The CDR system extracts data from both the structured and
unstructured datasets.
Structured data sources ‐ CRO Data, EDC Data, Safety data,
AERS data, Prescription Data, Patient Data, Purchased Trial
data, Dictionary Data and Coding Systems.
Unstructured datasets ‐ the documents such as IVRS.
The Source System Interface Architecture Component
manages the extraction, verification and integration of
“changed data” from the Source System into the “Interface
Design Framework” and facilitates its transfer to the Data
Staging Subcomponent.
Data Sources
Data
Sources

Data in the staging
layer
Verification
Cleaned Integrated
Transformed
Perform
conversions,
summarization and
condensation
Fails verification
Suspended
Processing
Quality Assurance
alert
Source System
Custodian
Resolution
Staging Layer
Staging
Layer

The key functionalities of this layer are:
• Discard any unwanted data
• Convert to common data names and definition
• Calculate summaries, aggregation and derived data
• Establish defaults for missing data
• Accommodate source data definition changes
Staging Layer
Staging
Layer

Slowly Changing Dimension Policy‐
This technique provides a data
warehouse with the flexibility of
preserving the representation of data.
Data entering the data warehouse has an integrated
structure and format. In addition, as the data
warehouse contains historical data, it must be capable
of holding and managing large volumes of data as well
as different data structures.
Data Warehouse Layer
Data
Warehouse
Layer

Reporting Layer
Reporting
Layer

CDR Framework

confidential

• Clinical and operational data reporting
• ensures the comply with regulatory requirements
• Enables comprehensive auditing of all programs, data, and reports
• Built to work with various analytics/visualization tools
• Offers workflow standardization for analysis and reporting
• Supports various standards such as SDTM and JANUS
• Provides out‐of‐the‐box integration with Oracle Clinical
CDR Advantages

Team Strength
confidential
HySynth personnel are proficient to use a wide range of technologies
including ARGUS Safety, Electronic Data Capture, Oracle Clinical, RDC,
SAS, TMS, FrameMaker and optical scanning
Technical Experts in OC/RDC, Argus, TMS, LSH, DMW, CDA, SAS, Inform,
Informatica, Java, PL/SQL, OBIEE, EntimICE, BIP, MDR, Medidata RAVE,
Business Objects, JReview, Spotfire, Oracle Ebusiness Suite, Oracle ADF,
Forms, OA Framework, DAC and Oracle Database programming and
administration.
A fully scalable, user friendly, FDA 21 CFR Part 11 compliant clinical data
management system
Over 100+ employees working in Multiple location and having capacity
to expand as per requirement (40000 sq. ft)
Department specific SOP’s, Work instructions and work flows

• 21 2U‐Rack mounted servers with tape backup (Dell 2950 with
21 Quad core Zeon processor servers and Raid 5 for Data
security)
• Business continuity plan/Disaster Recovery procedures
• Redundant on‐site/off‐site backup
• Information Security Policies and Rigorous IT SOPs
• Latest hardware/software (Dell Systems, Cisco powered
Networks, Sonic firewall, etc)
• UPS, Power backup/Generator facility
• 24/7 managed infrastructure by a team of skilled
Administrators
confidential
Infrastructure

Facility

IT Infrastructure

Maintenance and Support
confidential
• Help business for Troubleshooting functional issues
• Application maintenance
• Administration of OC/RDC/TMS, Argus, Inform, LSH, CDA, DMW and Oracle Database.
• Regular health checkups
• Applying bug and security Pâtés
• Troubleshooting and fixing technical issues
With multiple support channels:
• Live phone
• E‐mail
• Remote Access
• Knowledge base

HySynth Value proposition
confidential
Data Security &
Business Continuity
We follow information
security and recovery
polices in compliance with
applicable regulatory
requirements.
Data Quality
We ensure quality through
internal quality control,
adhering to our SOPs and
to best practices in the
industry
Validated Infrastructure
We operate in a fully
validated environment and
our systems have gone
through IQ/OQ/PQ. and
are 21CFR Part 11
compliant.
Personalized
Care/Customized Solution
Personalized service
through a project manager
who is a single point of
contact to provide
customized solutions for
the clients
Technical Expertise
Our SME’s have exposure
to a variety of projects
with varying degrees of
complexity will be able to
provide extensive support.
Qualified Team
Consistent and intensive
company‐wide training
program to build teams
before they start to work
on your project.
Time/Price Advantage
Faster completion of
projects due to
involvement of team
members from multiple
shift. Our business model
ensures huge cost savings.

Why HySynth
Life
Science
Technology
Medical
Coding
Biometrics
ICSR
processing
confidential

Contact Us
confidential
Head Quarters:
Robert V Chandran Tower
#149, Velachery ‐ Tambaram Main Road,
Pallikaranai, Chennai – 600 100
Tamilnadu, INDIA
Phone: +91 44 6452 1705 / 06
Fax: + 91 44 3042 0132
Email: info@hysynth.com

HySynth Clinical Data Repository

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