HySynth Life Science Technology

HySynth BioTechnologies

Robert V Chandran Tower#149, Velachery ‐ Tambaram Main Road,

Chennai, Tamilnadu, [email protected]

HySynth’s Life Science Technology (LST)


Pharmacovigilance

Bio‐Similar and Biomarker Research

Life Science Technology

Clinical Data Management


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)


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)


confidential

Life Science Technologies

Implementation & Customization

Clinical Data Repository

Clinical Development Analytics

Upgradation Migration

Integration

Study Setup


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


• 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


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CDISC Conversion


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Data Integration


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


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


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


• 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

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• 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

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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


• 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

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Infrastructure

HySynth BioTechnologies Facility

HySynth BioTechnologies IT Infrastructure

HySynth BioTechnologiesHySynth Value proposition

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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

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HySynth BioTechnologiesContact Us

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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]

mailto:[email protected]

HySynth Life Science Technology

Health & Medicine

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