Hysynth Clinical Development Analytics, Data Migration, Integration, Analytics

HySynth BioTechnologies

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

Chennai, Tamilnadu, [email protected]

HySynth’s Clinical Development Analytics (CDA)


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


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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)


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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Clinical Research


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Emerging Scenario


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Integration and Analytics

HySynth BioTechnologiesClinical Development Analytics (CDA)

• CDA is branch of clinical science which is examining raw

data with the purpose of drawing conclusions about

clinical information

• CDA is an extensible repository and reporting solution

that supports clinical operation and clinical data

management.

• CDA includes pre‐packaged interactive dashboards and

reports


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CDA Benefits

• Make better cross functional business decisions ‐ identify risks &

mitigate them in timely manner e.g. need of additional trainings for staff

at a site, fraud detection, signal detection, protocol deviations.

• Greater transparency into the status of a clinical trial subject

• Enhanced safety and efficacy monitoring via a holistic review of

individual and aggregated subject data

• Increased operational efficiency and quality made possible through a

transparent and holistic view of data

HySynth BioTechnologies Scenarios

– CRF Workload

– Discrepancy workload

– How long does a site takes to resolve discrepancies?

– On Which CRF page, the no. of Discrepancies are high?

– Which procedure generates more discrepancies?

– Approval and verification – worst performers

– Quality

– Patients awaiting first pass, second pass, verification and approval.

– Average days for verification and approval.

– Processing volumes.

HySynth BioTechnologiesCDA Answers

– an ad‐hoc query and analysis tool that processes the data from

multiple data sources in a pure web environment.

– Users are isolated from data structure complexity and they view and

work with a logical view of the information.

– Users can create interactive charts, pivot tables, reports, and

dashboards.

– Analysis can be saved, shared, modified, formatted, or integrated in

the user's dashboards.


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HySynth BioTechnologiesCDA Performance Management

HySynth BioTechnologies CDA Products • CDA v1.0 supports data source as OC and RDC. This support

only EDC/CDMS• CDA v2.0 supports both CTMS and OC/RDC.• Current version 2.1

HySynth BioTechnologies CDA Dashboards

– CRA Dashboard

– Data Manager – EDC Dashboard

– Data Manager‐ Paper Dashboard

– Study Manager Dashboard

– Study Overview Dashboard

– Study‐Site Overview Dashboard

– Index Dashboard

HySynth BioTechnologiesCDA SECURITY

– Study Manager : Access to Index and all dashboards

– CRA : Access to Index, Study Overview, Study‐Site

Overview and CRA dashboards

– Data Manager : Access to Index, Data Manager Paper, Data

Manager ‐EDC, Study Overview and Study‐Site

Overview dashboards

– Project Manager : Access to Index and all dashboards

– Admin : Access to all

HySynth BioTechnologiesCDA Reports and Dashboards

• Ad ‐ hoc Requests • Filter• Calculations• Data format• Column properties and Condition formatting• Save as new report• Add graphs • Add prompts• Create dashboards and flexibility• Dash board link• Alerts• Direct SQLs• Advanced Tab

HySynth BioTechnologiesCDA Work Flow

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 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]

Hysynth Clinical Development Analytics, Data Migration, Integration, Analytics

Technology

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