HySynth BioTechnologies Robert V Chandran Tower #149, Velachery ‐ Tambaram Main Road, Chennai, Tamilnadu, INDIA [email protected] HySynth’s Pharmacovigilance
May 10, 2015
HySynth BioTechnologies
Robert V Chandran Tower#149, Velachery ‐ Tambaram Main Road,
Chennai, Tamilnadu, [email protected]
HySynth’s Pharmacovigilance
HySynth BioTechnologies
Pharmacovigilance
Bio‐Similar and Biomarker Research
Life Science Technology
Clinical Data Management
HySynth BioTechnologies
confidential
Life Science Technologies
Implementation & Customization
Clinical Data Repository
Clinical Development Analytics
Upgradation Migration
Integration
Study Setup
HySynth BioTechnologies
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
• 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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HySynth BioTechnologies
• 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
HySynth BioTechnologies
• 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]