HySynth BioTechnologies
Robert V Chandran Tower#149, Velachery ‐ Tambaram Main Road,
Chennai, Tamilnadu, [email protected]
HySynth’s Clinical Development Analytics (CDA)
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 BioTechnologies
confidential
Clinical Research
HySynth BioTechnologies
confidential
Emerging Scenario
HySynth BioTechnologies
confidential
Integration and Analytics
HySynth BioTechnologiesClinical 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
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
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.
HySynth BioTechnologiesCDA 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.
HySynth BioTechnologies
confidential
HySynth BioTechnologiesCDA Performance Management
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
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
HySynth BioTechnologiesCDA 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
HySynth BioTechnologiesCDA 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
HySynth BioTechnologiesCDA Work Flow
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]