HySynth BioTechnologies
Robert V Chandran Tower
#149, Velachery ‐ Tambaram Main Road,
Chennai, Tamilnadu, INDIA
biometrics...
HySynth BioTechnologies
Pharmacovigilance 
Bio‐Similar and Biomarker Research
Life Science Technology
Clinical Data Manage...
HySynth BioTechnologies
confidential
Life Science 
Technologies
Implementation & 
Customization
Clinical Data 
Repository
...
HySynth BioTechnologies
confidential
We provide,
Business case development and cost analysis 
Requirements and design mana...
HySynth BioTechnologies
LST on the following applications
Argus Safety Suite
Oracle Clinical / Remote Data Capture (RDC) /...
HySynth BioTechnologies
HySynth BioTechnologies
confidential
Clinical Research
HySynth BioTechnologies
confidential
Emerging Scenario
HySynth BioTechnologies
confidential
Integration and Analytics 
HySynth BioTechnologies
Clinical Development Analytics (CDA)
• CDA is branch of clinical science which is examining raw 
d...
HySynth BioTechnologies
confidential
CDA Benefits
• Make better cross functional business decisions ‐ identify risks & 
mi...
HySynth BioTechnologies
Scenarios
– CRF Workload
– Discrepancy workload
– How long does a site takes to resolve discrepanc...
HySynth BioTechnologies
CDA Answers
– an ad‐hoc query and analysis tool that processes the data from 
multiple data source...
HySynth BioTechnologies
confidential
HySynth BioTechnologies
CDA Performance Management
HySynth BioTechnologies
CDA Products 
• CDA v1.0 supports data source as OC and RDC. This support 
only EDC/CDMS
• CDA v2....
HySynth BioTechnologies CDA Dashboards
– CRA Dashboard
– Data Manager – EDC Dashboard
– Data Manager‐ Paper Dashboard
– St...
HySynth BioTechnologies
CDA SECURITY
– Study Manager : Access to Index and all dashboards
– CRA   : Access to Index, Study...
HySynth BioTechnologies
CDA Reports and Dashboards 
• Ad ‐ hoc  Requests 
• Filter
• Calculations
• Data format
• Column p...
HySynth BioTechnologies
CDA Work Flow
HySynth BioTechnologies
Team Strength
confidential
HySynth personnel are proficient to use a wide range of technologies 
i...
HySynth BioTechnologies
• 21 2U‐Rack mounted servers with tape backup (Dell 2950 with 
21 Quad core Zeon  processor server...
HySynth BioTechnologies
Facility
HySynth BioTechnologies
IT Infrastructure
HySynth BioTechnologies
Maintenance and Support
confidential
• Help business for Troubleshooting functional issues
• Appli...
HySynth BioTechnologies
HySynth Value proposition
confidential
Data Security & 
Business Continuity
We follow information ...
HySynth BioTechnologies
Why HySynth
Life 
Science 
Technology
Medical 
Coding
Biometrics
ICSR 
processing
confidential
HySynth BioTechnologies
Contact Us
confidential
Head Quarters:
Robert V Chandran Tower
#149, Velachery ‐ Tambaram Main Roa...
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Hysynth Clinical Development Analytics, Data Migration, Integration, Analytics

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CDA is branch of clinical science which is examining raw data with the purpose of drawing conclusions about clinical information.
CDA is an extensible repository and reporting solution that supports clinical operation and clinical data management.
CDA includes pre-packaged interactive dashboards and reports.

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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Hysynth Clinical Development Analytics, Data Migration, Integration, Analytics

  1. 1. HySynth BioTechnologies Robert V Chandran Tower #149, Velachery ‐ Tambaram Main Road, Chennai, Tamilnadu, INDIA biometrics@hysynth.com HySynth’s Clinical Development Analytics (CDA)
  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 confidential Clinical Research
  8. 8. HySynth BioTechnologies confidential Emerging Scenario
  9. 9. HySynth BioTechnologies confidential Integration and Analytics 
  10. 10. HySynth BioTechnologies Clinical Development Analytics (CDA) • CDA is branch of clinical science which is examining raw  data with the purpose of drawing conclusions about  clinical information  • CDA is an extensible repository and reporting solution  that supports clinical operation and clinical data  management. • CDA includes pre‐packaged interactive dashboards and  reports
  11. 11. HySynth BioTechnologies confidential CDA Benefits • Make better cross functional business decisions ‐ identify risks &  mitigate them in timely manner e.g. need of additional trainings for staff  at a site, fraud detection, signal detection, protocol deviations.  • Greater transparency into the status of a clinical trial subject  • Enhanced safety and efficacy monitoring via a holistic review of  individual and aggregated subject data  • Increased operational efficiency and quality made possible through a  transparent and holistic view of data 
  12. 12. HySynth BioTechnologies Scenarios – CRF Workload – Discrepancy workload – How long does a site takes to resolve discrepancies? – On Which CRF page, the no. of Discrepancies are high? – Which procedure generates more discrepancies? – Approval and verification – worst performers – Quality  – Patients awaiting first pass, second pass, verification and approval. – Average days for verification and approval. – Processing volumes.
  13. 13. HySynth BioTechnologies CDA Answers – an ad‐hoc query and analysis tool that processes the data from  multiple data sources in a pure web environment.  – Users are isolated from data structure complexity and they view and  work with a logical view of the information.  – Users can create interactive charts, pivot tables, reports, and  dashboards.  – Analysis can be saved, shared, modified, formatted, or integrated in  the user's dashboards.
  14. 14. HySynth BioTechnologies confidential
  15. 15. HySynth BioTechnologies CDA Performance Management
  16. 16. HySynth BioTechnologies CDA Products  • CDA v1.0 supports data source as OC and RDC. This support  only EDC/CDMS • CDA v2.0 supports both CTMS and OC/RDC. • Current version 2.1
  17. 17. HySynth BioTechnologies CDA Dashboards – CRA Dashboard – Data Manager – EDC Dashboard – Data Manager‐ Paper Dashboard – Study Manager Dashboard – Study Overview Dashboard – Study‐Site Overview Dashboard – Index Dashboard 
  18. 18. HySynth BioTechnologies CDA SECURITY – Study Manager : Access to Index and all dashboards – CRA   : Access to Index, Study Overview, Study‐Site  Overview and CRA dashboards – Data Manager : Access to Index, Data Manager Paper, Data  Manager ‐EDC, Study Overview and Study‐Site  Overview dashboards – Project Manager : Access to Index and all dashboards – Admin  : Access to all
  19. 19. HySynth BioTechnologies CDA Reports and Dashboards  • Ad ‐ hoc  Requests  • Filter • Calculations • Data format • Column properties and Condition formatting • Save as new report • Add graphs  • Add prompts • Create dashboards and flexibility • Dash board link • Alerts • Direct SQLs • Advanced Tab
  20. 20. HySynth BioTechnologies CDA Work Flow
  21. 21. 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
  22. 22. 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
  23. 23. HySynth BioTechnologies Facility
  24. 24. HySynth BioTechnologies IT Infrastructure
  25. 25. 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
  26. 26. 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.
  27. 27. HySynth BioTechnologies Why HySynth Life  Science  Technology Medical  Coding Biometrics ICSR  processing confidential
  28. 28. 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

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