HySynth Clinical Data Management

HySynth BioTechnologies

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

Chennai,Tamilnadu, [email protected]

HySynth’s Clinical Data Management (CDM)


Pharmacovigilance

Bio‐Similar and Biomarker Research

Life Science Technology

Clinical Data Management


confidential

Life Science Technologies

Implementation & Customization

Clinical Data Repository

Clinical Development Analytics

Upgradation Migration

Integration

Study Setup


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


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)


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

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Biostatistics

Study Conduct

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IT Information Technology

IT IT

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


• 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


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


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


• 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]

mailto:[email protected]

Health & Medicine

HySynth Clinical Data Management