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)

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HySynth Clinical Data Repository

  1. 1. HySynth BioTechnologies Robert V Chandran Tower #149, Velachery ‐ Tambaram Main Road, Chennai, Tamilnadu, INDIA biometrics@hysynth.com HySynth’s Clinical Data Repository 
  2. 2. HySynth BioTechnologies Pharmacovigilance  Bio‐Similar and Biomarker Research Life Science Technology Clinical Data Management
  3. 3. HySynth BioTechnologies confidential Life Science  Technologies Implementation &  Customization Clinical Data  Repository Clinical  Development  Analytics Upgradation Migration Integration Study Setup
  4. 4. 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)
  5. 5. HySynth BioTechnologies 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)
  6. 6. HySynth BioTechnologies
  7. 7. HySynth BioTechnologies 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.
  8. 8. 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
  9. 9. HySynth BioTechnologies 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
  10. 10. HySynth BioTechnologies • 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) 
  11. 11. HySynth BioTechnologies confidential Clinical Data Repository (CDR) 
  12. 12. HySynth BioTechnologies 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
  13. 13. HySynth BioTechnologies Data  Sources Staging  Layer Data  Warehouse  Layer Reporting  Layer CDR architecture
  14. 14. HySynth BioTechnologies 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
  15. 15. 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
  16. 16. 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
  17. 17. 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
  18. 18. HySynth BioTechnologies Reporting Layer Reporting  Layer
  19. 19. HySynth BioTechnologies CDR Framework
  20. 20. HySynth BioTechnologies confidential
  21. 21. 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
  22. 22. 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
  23. 23. 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
  24. 24. HySynth BioTechnologies Facility
  25. 25. HySynth BioTechnologies IT Infrastructure
  26. 26. HySynth BioTechnologies 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
  27. 27. HySynth BioTechnologies 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.
  28. 28. HySynth BioTechnologies Why HySynth Life  Science  Technology Medical  Coding Biometrics ICSR  processing confidential
  29. 29. HySynth BioTechnologies 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