HySynth Pharmacovigilance
HySynth Biotechnologies’s Pharmacovigilance group provides a range of tailored Pharmacovigilance (PV) and Biovigilance (Hemovigilance) services that can effectively address the needs of biopharmaceutical companies of all sizes. With people over 10 years of medical, technology and compliance expertise, we are able to provide diligently managed, flexible and cost-effective solutions. With a full suite of scalable and flexible solutions, we can provide tools and techniques to achieve patient safety, regulatory compliance and long-term strategic advantage. Our service packages are customized as per requisite of the organization and delivered through a lean operational model which includes, Triage till Medical Review, Case Processing, Case Reporting, Single Case Narrative writing, Aggregate Report writing, Literature Search, etc. Medical 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. ICSR Processing: The processing of individual case safety reports (ICSRs) originating from various sources which 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/Pharmacovigilance database, after a duplicate check. This involves an initial triage followed by Data processing and a subsequent medical review by a physician. After the review process, the case reports are submitted to the regulatory authorities/business partners. HySynth’s people have extensive experience across all case types and have worked with all commercially available drug safety databases, such as Argus Safety, ARISg, Empirica Trace and proprietary client databases.
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HySynth Pharmacovigilance
- 6. HySynth BioTechnologies • HySynth Biotechnologies’s Pharmacovigilance group provides a range of tailored Pharmacovigilance (PV) and Biovigilance (Hemovigilance) services that can effectively address the needs of biopharmaceutical companies of all sizes. • With people over 10 years of medical, technology and compliance expertise, we are able to provide diligently managed, flexible and cost‐effective solutions. • With a full suite of scalable and flexible solutions, we can provide tools and techniques to achieve patient safety, regulatory compliance and long‐term strategic advantage. • Our service packages are customized as per requisite of the organization and delivered through a lean operational model which includes, Triage till Medical Review, Case Processing, Case Reporting, Single Case Narrative writing, Aggregate Report writing, Literature Search, etc. confidential
- 7. 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
- 8. HySynth BioTechnologies Medical 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 confidential Process Approach
- 9. HySynth BioTechnologies Process 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 confidential
- 10. HySynth BioTechnologies ICSR Processing • The processing of individual case safety reports (ICSRs) originating from various sources which 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/Pharmacovigilance database, after a duplicate check. • This involves an initial triage followed by Data processing and a subsequent medical review by a physician. After the review process, the case reports are submitted to the regulatory authorities/business partners. • HySynth’s people have extensive experience across all case types and have worked with all commercially available drug safety databases, such as Argus Safety, ARISg, Empirica Trace and proprietary client databases. confidential
- 11. HySynth BioTechnologies ICSR 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 confidential
- 12. HySynth BioTechnologies Aggregate 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 confidential
- 14. HySynth BioTechnologies Literature 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 confidential
- 15. 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
- 16. 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 confidential Infrastructure
- 19. HySynth BioTechnologies Maintenance 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