HySynth Biotechnologies

HySynth BioTechnologies

Robert V Chandran Towers, 5th Floor, #149, Velachery‐Tambaram Main Road,

Pallikaranai,Chennai – 600 100.Tamilnadu, INDIA.www.hysynth.com


HySynth is an Independent Research Organization based in Chennai, South India.

HySynth provides entire gamut of Drug Development Services to the Pharmaceutical,

Biotechnology and Medical Device Companies.

HySynth committed to support the sponsor to meet the global challenges of drug

development process through quality scientific research services.

About Us


Clinical Data Management

Life Science Technology

Pharmacovigilance

HySynth BioTechnologies 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


Dr. M. Vasudevan, Managing Director

Dr. M. Vasudevan holds a Doctorate in Pharmacy and has worked inseveral pharmaceutical companies at senior management levels

Has over 20 years of pharmaceutical research experience

His expertise includes Preclinical, Clinical Research and Bioequivalencestudies

Has coordinated several Regulatory audits including ANVISA, USFDA, MHRA etc.

He is also an acclaimed academician having several research papers tohis credit


• Surya has been actively involved in the field of Healthcare IT for 20+ years.

• Over the many years he has gained extensive knowledge and experience in thedesign and development of intelligent systems in several domains including ‐therapeutic diet planning, crisis management, configuration planning,defensive/offensive campaign planning, clinical decision support systems,clinical IT support, healthcare BI and embedded systems.

• Surya has published numerous research papers in the fields of ArtificialIntelligence and Healthcare and holds patents in over 25 countries.

• He has received his masters degree specializing in artificial intelligence fromthe University of Illinois at Urbana‐Champaign.

Surya Ramachandran, Executive Director & CEO


8 KM away from Airport

Facility

HySynth BioTechnologies Facility

HySynth BioTechnologies Facility

HySynth BioTechnologies IT Infrastructure


• Licensed software's include

• ARGUS SAFETY

• Oracle Clinical with RDC

• SAS Pheedit

• Crystal Reports

• WinNonlin

• LIAS

• Rights Management System

• Dell 2950 with 21 Quad core Zeon processor servers and Raid 5 for Data security

• Production servers will be hosted at a Level III data centre with redundant ITinfrastructure like power and internet connectivity, regular scheduled backups anddisaster recovery.

• Scalable according to client requisite

Infrastructure


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FPFV: First Patient First Visit LPLV: Last Patient Last Visit


HySynth CDM services includes but not limited to:

• Project management

• CRF/eCRF design

• Database built ,design & programming

• Data entry , Validation and Discrepancy Management

• External Data Handling (SAE, labs, device data, etc)

• AE/Con Med/Disease coding

• Quality Review & reconciliation

• Biostatistics

• Data Migration

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CDM Services



Preparation, Assessment and Reporting of ICSRs and Aggregate Safety Reports

Adverse Event (AE) and Serious Adverse Event (SAE) Management

Assessment of Causality and Expectedness of Adverse/SAEs

Medical Monitoring/Signal Detection

Literature Search

HySynth BioTechnologies ICSR Case Processing Workflow

Sponsor Case Receipt Triage Case evaluation Case Prioritization

Data Processing

Non‐Expedited (within 72 hrs)

Expedited (within 24 hrs)

Quality ReviewMedical ReviewReporting (E2B/Paper mail)

Tracking, Reconciliation and Filing

HySynth BioTechnologies HB’s ICSR QR Work‐Flow

Case Intake

Case Filing

Triage

Data Entry, Coding, Narrative Writing

Medical Review

Reporting and Submission

QUALITY

REVIEW

Post Triage

Post Data Entry

Post Medical Review

Post Reporting

HySynth BioTechnologiesAggregate Report/Safety Writing

Periodic Safety Update Reports

(PSURs)

Periodic Adverse Drug Experience Reports (PADERs)

Addendum PSURs

Summary Bridging Reports

(SBRs) SUSAR Reports Annual Safety

Reports (ASRs)

Development Safety Update Reports (DSURs)

Drug Safety Reports (DSRs)

Other Related services

This service entails the analysis of grouped/aggregate data by HB’s scientists and physicians, data and the subsequent incorporation of such data into prescribed reports on behalf of our clients.

These reports include:



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Life Science Technologies

Implementation & Customization

Clinical Data Repository

Clinical Development Analytics

Upgradation Migration

Integration

Study Setup


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)


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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)


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Increase adoption of CDISC Standards• SDTM• CDASH• New CDISC Standards (Therapeutic area specific)Clinical data integration• eCRFs• ePRO• IVRS• CTMS• Central LabIncrease use of • Clinical Data Repository (CDR)• Clinical Development Analytics (CDA)

LST Emerging Scenario


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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

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 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]