HySynth Clinical Data Repository
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HySynth BioTechnologies
Robert V Chandran Tower#149, Velachery ‐ Tambaram Main Road,
Chennai, Tamilnadu, [email protected]
HySynth’s Clinical Data Repository
HySynth BioTechnologies
Pharmacovigilance
Bio‐Similar and Biomarker Research
Life Science Technology
Clinical Data Management
HySynth BioTechnologies
confidential
Life Science Technologies
Implementation & Customization
Clinical Data Repository
Clinical Development Analytics
Upgradation Migration
Integration
Study Setup
HySynth BioTechnologies
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)
HySynth BioTechnologies
LST on the following applicationsArgus 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)
HySynth BioTechnologies
HySynth BioTechnologiesNeed 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.
HySynth BioTechnologies
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
HySynth BioTechnologies
confidential
Increase adoption of CDISC Standards• SDTM• CDASH• New CDISC Standards (Therapeutic area specific)Clinical data integration• eCRFs• ePRO• IVRS• CTMS• Central LabIncrease use of • Clinical Data Repository (CDR)• Clinical Development Analytics (CDA)
LST Emerging Scenario
HySynth BioTechnologies
• CDR is used for storing, integrating ,managing and reporting on clinicalstudies.
• It enables pooling of clinical and nonclinical data from multiple sources intoa single environment.
• Better regulatory compliance with comprehensive security, an audit trail,and traceability
• More‐informed decision‐making through pooling and analysis of clinicaland 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)
HySynth BioTechnologies
confidential
Clinical Data Repository (CDR)
HySynth BioTechnologiesCDR 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
HySynth BioTechnologies
Data Sources
Staging Layer
Data Warehouse
Layer
Reporting Layer
CDR architecture
HySynth BioTechnologies
The CDR system extracts data from both the structured andunstructured datasets.
Structured data sources ‐ CRO Data, EDC Data, Safety data,AERS data, Prescription Data, Patient Data, Purchased Trialdata, Dictionary Data and Coding Systems.
Unstructured datasets ‐ the documents such as IVRS.
The Source System Interface Architecture Componentmanages the extraction, verification and integration of“changed data” from the Source System into the “InterfaceDesign Framework” and facilitates its transfer to the DataStaging Subcomponent.
Data Sources
Data Sources
HySynth BioTechnologies
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
HySynth BioTechnologies
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
HySynth BioTechnologies
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
HySynth BioTechnologiesReporting Layer
Reporting Layer
HySynth BioTechnologiesCDR Framework
HySynth BioTechnologies
confidential
HySynth BioTechnologies
• 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
HySynth BioTechnologies 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
HySynth BioTechnologies
• 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
HySynth BioTechnologies Facility
HySynth BioTechnologies IT Infrastructure
HySynth BioTechnologiesMaintenance 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 BioTechnologiesHySynth 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.
HySynth BioTechnologies Why HySynth
Life Science
Technology
Medical Coding
Biometrics
ICSR processing
confidential
HySynth BioTechnologiesContact Us
confidential
Head Quarters:Robert V Chandran Tower#149, Velachery ‐ Tambaram Main Road,Pallikaranai, Chennai – 600 100Tamilnadu, INDIAPhone: +91 44 6452 1705 / 06Fax: + 91 44 3042 0132Email: [email protected]