HySynth Pharmacovigilance

HySynth BioTechnologies

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

Chennai, Tamilnadu, [email protected]

HySynth’s Pharmacovigilance


Pharmacovigilance

Bio‐Similar and Biomarker Research

Life Science Technology

Clinical Data Management


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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)

HySynth BioTechnologiesPharmacovigilance Services

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PV Services

ICSR processing

Support Services

Aggregate reporting

Medical Coding

Literature Search

Hemovigilance / Biovigilance

Safety Writing


• HySynth Biotechnologies’s Pharmacovigilance group provides a range of tailoredPharmacovigilance (PV) and Biovigilance (Hemovigilance) services that can effectivelyaddress the needs of biopharmaceutical companies of all sizes.

• With people over 10 years of medical, technology and compliance expertise, we are able toprovide diligently managed, flexible and cost‐effective solutions.

• With a full suite of scalable and flexible solutions, we can provide tools and techniques toachieve patient safety, regulatory compliance and long‐term strategic advantage.

• Our service packages are customized as per requisite of the organization and deliveredthrough a lean operational model which includes, Triage till Medical Review, CaseProcessing, Case Reporting, Single Case Narrative writing, Aggregate Report writing,Literature Search, etc.

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• MedDRA and WHO DD Coding

• Assessment on expedited and electronic reporting of ICSR & additional safety information for authorized medicinal products

• Adverse events case quality review

• literature monitoring to identify adverse events and safety data

• Aggregate Reporting

• Signal detection and evaluation

• Risk management plan

Core Area Training

• Good PV Practices

• Case Processing – ARISg and ARGUS

• Narrative writing

• PV – Query Handling

• Refresher training

• Reference Safety Information

• Quality management system

• EEA‐QPPV Roles and Responsibilities

HySynth BioTechnologiesMedical Analysis

• AE and SAE evaluations

• MedDRA and WHO‐DD Coding

• SAE narrative writing

• Causality and Labeling Assessments

• Physician medical review and signal detection

• Literature reviews and summaries

• Updating CCDS and other Core documents

Regulatory Reporting

• Expedited Reporting: Generation of MedWatch 3500A/CIOMS I forms

• Preparation of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)

• Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction (SUSAR) reports via E2B and Paper mail

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Process Approach

HySynth BioTechnologiesProcess Approach

Electronic Adverse Event Processing and Reporting

• Flexibility to use our clients’ proprietary or licensed electronic reporting

systems.

• Argus Safety™, a leading technology for SAE and AE case management

and reporting. Our Argus Safety license allows us to provide a fully

validated 21 CFR Part 11 compliant system that can be customized to

meet your needs.

End‐User Focused Approach

• We follow the ICH Efficacy guidelines, FDA's Good Pharmacovigilance

Practice, EMEA's European Directive 2001/20/EC guidelines and EU

Modules (released) focus our work‐products on the end‐user

perspective

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HySynth BioTechnologiesICSR Processing

• The processing of individual case safety reports (ICSRs) originating from various sourceswhich includes,

• Post‐marketing non‐solicited/ Spontaneous reports

• Clinical Reports

• Special reports (Medico‐legal, Literature & E2B)

• Related Sources

• Following established guidelines, data from source documents sent by clients are processed(data entry, MedDRA coding and safety narrative) in to a Drug Safety/Pharmacovigilancedatabase, after a duplicate check.

• This involves an initial triage followed by Data processing and a subsequent medical reviewby a physician. After the review process, the case reports are submitted to the regulatoryauthorities/business partners.

• HySynth’s people have extensive experience across all case types and have worked with allcommercially available drug safety databases, such as Argus Safety, ARISg, Empirica Trace andproprietary client databases.

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HySynth BioTechnologiesICSR Processing Workflow

Sponsor Case Receipt Triage Case evaluation Case Prioritization

Data Processing

Non‐Expedited (within 72 hrs or as expected)

Expedited (within 24 hrs or as expected)

Quality ReviewMedical ReviewReporting (E2B/Paper mail)

Tracking, Reconciliation and Filing

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HySynth BioTechnologiesAggregate Report/Safety Writing

Safety Writing involves the analysis of data aggregated by HySynth’s scientists and physicians. The data is subsequently incorporated into prescribed reports.

The reports include:

• Periodic Safety Update Reports (PSUR) / (PBRER)

• 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

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HySynth BioTechnologiesQuality Approach

Case Intake

Case Filing

Triage

Data Entry, Coding, Narrative Writing

Medical Review

Reporting and Submission

QUALITY

REVIEW (if

needed)

Post Triage

Post Data Entry

Post Medical Review

Post Reporting

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HySynth BioTechnologiesLiterature Search

The main services includes,

• Search on various databases like PubMed, DataStar etc.

• Review of abstracts for inclusion in ICSR, PSURs and other specialized reports

• Request for articles through libraries and portals

• Request for translation if needed

• Review of articles for inclusion in ICSR, PSURs and other specialized reports

Literature search is performed on the various databases and reviewed

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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 Pharmacovigilance

Health & Medicine

Transcript of HySynth Pharmacovigilance