Date post: | 12-Jun-2015 |
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Health & Medicine |
Upload: | mahalingam-vasudevan |
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HySynth BioTechnologies
Robert V Chandran Tower#149, Velachery ‐ Tambaram Main Road,
Chennai, Tamilnadu, [email protected]
HySynth’s Life Science Technology (LST)
HySynth BioTechnologies
Pharmacovigilance
Bio‐Similar and Biomarker Research
Life Science Technology
Clinical Data Management
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
confidential
Life Science Technologies
Implementation & Customization
Clinical Data Repository
Clinical Development Analytics
Upgradation Migration
Integration
Study Setup
HySynth BioTechnologies
Our end‐to‐end implementation services include
Implementation strategy and roadmap
Implementation and customize to business requirements
Validation, Maintenance and support
On the following Life Sciences Oracle applicationsArgus Safety Suite
Oracle Clinical / Remote Data Capture (RDC) /Thesaurus
Management System (TMS)
Oracle Inform EDC / Central Designer / Central Coding
Oracle Life Sciences Data Hub (LSH)
Oracle Data Management Workbench (DMW)
Oracle Clinical Development Analytics (CDA)
Adverse Event Reporting System (AERS)
Implementation and Customizations
HySynth BioTechnologies
• Assessment of current IT environment
• Application performance analysis and recommendations
• Vendor and application selection
• Vendor audit
• Business case development and cost analysis
• Planning IT strategy and roadmap
• Requirements and design management
• Pilots and proofs of concept
• 21 CFR Part 11 guidance
• Business process management
• Business process reengineering , Best practice analysis and
recommendations
Consulting
HySynth BioTechnologies
confidential
CDISC Conversion
HySynth BioTechnologies
confidential
Data Integration
HySynth BioTechnologies
Our team of specialists can help you leverage the benefits of system integration
Improved and streamlined business processes
Reduction in maintenance and technology costs
Elimination of redundant tasks
Several integration projects that we completed over the years include:
• Oracle LSH with third‐party tools
• Custom / homegrown clinical and Safety applications
with any other applications.
• Oracle Clinical / Simple Forms
• Oracle Clinical / Adverse Event Management System (AERS)
• Oracle Clinical / Imaging Systems
• Oracle Clinical / Interactive Voice Response Systems (IVRS)
Data Integration
HySynth BioTechnologies
Our innovative application development process and in‐depth knowledge of
the life sciences industry allows you to
Meet organizational business objectives and requirements
Reduce total cost of ownership
Compliance with 21 CFR Part 11
Achieve flexibility and scalability
Increase productivity
Application Development
HySynth BioTechnologiesData Migration
confidential
Data migration we can help your organization, includes
• Adverse Event Reporting System (AERS) to Argus Safety
• ARISg to Argus Safety
• Excel to Argus Safety
• Clinical data between Oracle Clinical instances
• Any homegrown/legacy system to any
Oracle application
HySynth BioTechnologies
Recent versions of several systems we specialize in include
Oracle LSH version installation and upgrades
OCDA and OCDA plus installation and upgrades
Argus Safety Suite 7.0.3
Adverse Event Reporting System (AERS) 4.7.0.6
Oracle Clinical / Remote Data Capture (RDC) 4.6.6
Thesaurus Management System (TMS) 4.6.6
Simple Forms 2.6.2
Upgradation
HySynth BioTechnologiesValidation
confidential
• Our validation experts can prepare from Validation plan to Validation summary and
help in IQ/OQ and PQ process and documentation.
• We also have validation accelerators thru which the documentation process can be
speed up and achieve compliance with Computer system validation guidelines and 21
CFR Part 11 guidelines.
HySynth BioTechnologiesHosting and Managed Services
confidential
Hosting: We can host your clinical and safety applications in a state‐of‐the‐art data center and provide a
comprehensive set of services to manage them.
Server and Application Management: We proactively update, back up, monitor, and manage all your
servers and applications remotely. Every aspect is monitored and issues can be identified and fixed before they
can cause a problem. You can rest assured knowing your data and systems are being monitored and protected
24/7 from our dedicated support team.
Application Support / Help Desk: Get quick support by telephone or
submit and track a help ticket through the Internet 24 hours a day, 7 days
a week via our unique application support system. We can fix most problems
remotely, so that you can be back up and running without having to wait
for a technician to come to your office. We can help with both application
and server issues.
HySynth BioTechnologiesStudy Setup
confidential
We can help you with paper or electronic study setup activities, such as with the initial setup of
studies and ongoing support of
• Data specifications documents
• Annotated CRF/eCRFs
• Data management plans and CRF/eCRF completion guidelines
• Procedure specifications (e.g., edit checks)
• Validation and derivation procedures
• Study protocols and study sites
• Global library standard objects and procedures
• Data extract views
HySynth BioTechnologiesClinical Development Analytics
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)
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 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 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]