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HySynth CDM services includes but not limited to: - Project management & Protocol review - CRF/eCRF design - Database built ,design & programming. - Data entry & Validation. - Discrepancy Management. - External Data Handling (SAE, labs, device data, etc) - AE/Con Med/Disease coding. - Quality Review & reconciliation. - Biostatistics - Archival & documentation. - Data Migration HySynth Provides 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 CDM 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 BioTechnologies
Robert V Chandran Towers#149 , Velachery ‐Tambaram Main Road,
Chennai,Tamilnadu, INDIAinfo@hysynth.com
HySynth’s Clinical Data Management (CDM)
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
HySynth CDM services includes but not limited to:• Project management & Protocol review• CRF/eCRF design• Database built ,design & programming.• Data entry & Validation.• Discrepancy Management.• External Data Handling (SAE, labs, device data, etc)• AE/Con Med/Disease coding.• Quality Review & reconciliation.• Biostatistics• Archival & documentation.• Data Migration.
confidential
CDM services
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
CDM 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
CDM : Application
HySynth BioTechnologiesPr
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Data Management
Clinical Operations
Biostatistics
Study Conduct
Med
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ing
Study Setup
Clinical Data Management (CDM)
DM DM
Go-Live /FPFV
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Study Closeout
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IT Information Technology
IT IT
IT
FPFV: First Patient First Visit LPLV: Last Patient Last Visit
HySynth BioTechnologies
• Oracle Clinical 4.5.3• Oracle RDC and Onsite 4.5.3• Oracle TMS 4.6• ARGUS Safety 6.0• SAS PheedIT• Crystal reports• WinNonlin• FrameMaker™• Rights Management System.
confidential
CDM Platforms
HySynth BioTechnologies
Project Management
• Initiate, Execute, monitor all project related activities
• CRF Designing
Database Administration
• Database creation, updation, modification, Production & Documentation
Data Processing / Entry
• Data Entry, Scanning, Indexing & Documentation
Discrepancy Management
• Creation and testing of edit checks
• Discrepancy Management, Reconciliation, Manual Review & Documentation
Our Core Team
confidential
Coding
• Coding review, Coding Query handling
Quality Review
• Quality check of Data Entry
• Validation & Final Report Review
Biostatistics
• Creation of Tables, Listings & Figures
• Prepare integrated & Statistical Reports
HySynth BioTechnologies
confidential
Biostatistics Services
• Assistance with study design and sample size determination
• Development of statistical analysis plans
• Randomization schedules
• CDISC format and conversion of Study data
• Tables, Listings and Graphs
• Complex data integration and data conversion for integrated reporting (e.g., ISS/ISE)
• Data Migration
Hysynth’s services in Statistical Programming include all activities right from Programming to
Reporting:
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: info@hysynth.com
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