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HySynth BioTechnologies Robert V Chandran Tower #149, Velachery Tambaram Main Road, Chennai, Tamilnadu, INDIA [email protected] HySynth’s Clinical Data Repository

HySynth Clinical Data Repository

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HySynth Clinical Data Repository 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 At HySynth 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 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

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Page 1: HySynth Clinical Data Repository

HySynth BioTechnologies

Robert V Chandran Tower#149, Velachery ‐ Tambaram Main Road,

Chennai, Tamilnadu, [email protected]

HySynth’s Clinical Data Repository 

Page 2: HySynth Clinical Data Repository

HySynth BioTechnologies

Pharmacovigilance 

Bio‐Similar and Biomarker Research

Life Science Technology

Clinical Data Management

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HySynth BioTechnologies

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Life Science Technologies

Implementation & Customization

Clinical Data Repository

Clinical Development Analytics

Upgradation Migration

Integration

Study Setup

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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)

Page 5: HySynth Clinical Data Repository

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)

Page 6: HySynth Clinical Data Repository

HySynth BioTechnologies

Page 7: HySynth Clinical Data Repository

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.

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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

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HySynth BioTechnologies

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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

Page 10: HySynth Clinical Data Repository

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) 

Page 11: HySynth Clinical Data Repository

HySynth BioTechnologies

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Clinical Data Repository (CDR) 

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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

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HySynth BioTechnologies

Data Sources

Staging Layer

Data Warehouse 

Layer

Reporting Layer

CDR architecture

Page 14: HySynth Clinical Data Repository

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

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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

Page 16: HySynth Clinical Data Repository

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

Page 17: HySynth Clinical Data Repository

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

Page 18: HySynth Clinical Data Repository

HySynth BioTechnologiesReporting Layer

Reporting Layer

Page 19: HySynth Clinical Data Repository

HySynth BioTechnologiesCDR Framework

Page 20: HySynth Clinical Data Repository

HySynth BioTechnologies

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Page 21: HySynth Clinical Data Repository

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

Page 22: HySynth Clinical Data Repository

HySynth BioTechnologies Team Strength

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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

Page 23: HySynth Clinical Data Repository

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

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Infrastructure

Page 24: HySynth Clinical Data Repository

HySynth BioTechnologies Facility

Page 25: HySynth Clinical Data Repository

HySynth BioTechnologies IT Infrastructure

Page 26: HySynth Clinical Data Repository

HySynth BioTechnologiesMaintenance and Support

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• 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

Page 27: HySynth Clinical Data Repository

HySynth BioTechnologiesHySynth Value proposition

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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.

Page 28: HySynth Clinical Data Repository

HySynth BioTechnologies Why HySynth

Life Science 

Technology

Medical Coding

Biometrics

ICSR processing

confidential

Page 29: HySynth Clinical Data Repository

HySynth BioTechnologiesContact Us

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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]