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REAL WORLD CASE STUDY

REAL WORLD CASE STUDY. Real-World Case Study. 1. Case Intake/Case Processing. 100% compliance to timelines and quality. ~ 2000 cases processed per month. 24/7 contact Centre. Outcomes. Business Need. Solution.

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REAL WORLD CASE STUDY

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  1. REAL WORLD CASE STUDY

  2. Real-World Case Study 1. Case Intake/Case Processing 100% compliance to timelines and quality ~ 2000cases processed per month 24/7contact Centre Outcomes Business Need Solution • Client was looking for a comprehensive solution to streamline case processing and drive productivity and compliance • Heavy volume overload of ICSRs, aggregate reports and other safety documents • Dedicated team of PV Executives, Drug Safety Associates, Medical Reviewers, and Operational Specialists • Dedicated call centre team to manage day-to-day case flow for global and regional requirement (all EU Regions) • Literature cases, spontaneous/ post-marketing and legal cases • Met timelines - 100% for serious case and >98% for non-serious cases • Met quality ≥ 98% and regulatory submission compliance ≥ 98% • Rapid improvement in regulatory submissions and sustained compliance • Scope of work expanded to provide support in literature screening, authoring aggregate reports and other safety documents

  3. Real-World Case Study 2. Case Processing and Aggregate Report Quality Assurance Activities 100% compliance to timelines <0.2% inappropriate errors flagged 2-week Transition period Outcomes Business Need Solution • Client was facing quality issues with case processing by existing vendor, and required a QA layer to manage quality of ICSR • Expected QA activities included SOP compliance, reviewing sources documents, verification of case receipt and creation date • QA activity also included checking literature screening process output and PBRERs • Complete offshore CoE team of QA specialists for monthly 10% sample review • All the findings were sent back to the originator vendor for root cause and CAPA • Annual Volumes: 3000 ICSRs, 1200 literature screening, 360 search check and 20 PBRERs • 100% compliance to turn around time and <0.2% inaccurate/inappropriate errors flagged • 3000+ data entry errors and 2000+ QC errors captured in ICSR • 100% CAPA tracked till closure • On-going QA support for ICSRs and periodic reports with dedicated 5 QA specialists

  4. Real-World Case Study 3. CoE for Authoring Safety Documents 100% compliance to timelines and Quality Consistently <0.5% Errors/ page >3000 documents* Outcomes Business Need Solution • Extended partnership model to manage a number of safety documents with the objective of driving overall productivity • Engagement to be initiated as pilot project and encompassed authoring, updating, and quality checking simple/complex medical documents • Deployed medical reviewer, senior authors, and a scientific editor; Authors took up end-to-end responsibility for the assigned documents • Created a 1-many hub to collaborate with multiple stakeholders across 15 countries • Entered into a multi-year contract with scope and volume expansion; team size increased to 25 resources • Currently, in the 3rd year of engagement, over 3000 simple/complex documents authored and updated in the last 2 years

  5. Real-World Case Study 4. CoE for Authoring Aggregate Reports 100% compliance to timelines and Quality Consistently <0.5% Errors/ page >3000 documents* Outcomes Business Need Solution • To expand pharmacovigilance outsourcing initiative beyond case processing to include the authoring of aggregated reports • Scope included call for coordination for contributions, to author non-safety sections of PSURs/PBRERs/PADERs, and final compilation of reports • A team of reviewers and aggregate report writers were deployed to support aggregate report preparation for OTC and generic products • Additional resources were deployed to support ad hoc request to author addendum report and CO, SBRs, and commented line-listings • Consistent positive feedback of ‘Exceeds Expectation’ for quality, timelines, and communication • ~90 reports were developed in 6 months • The scope was expanded to include authoring of all sections of PSURs/PBRERs/PADERs, aggregate report preparation for innovator products • Multi-year contract in place with average volume of 250 reports per year; team size increased to 15

  6. Real-World Case Study 5. Risk Management Plan 100% compliance to timelines <0.5 errors per page ~600 Products managed Outcomes Business Need Solution • Develop/ update Risk Management Plans (RMPs) for both innovator and generic products. • Preparation of RMP: Aggregate Analysis, Risk-Benefit Assessment, medical analysis and medical writing • Updates to RMPs and REMS Medication guide • Deployed a team of senior authors, safety scientist, medical reviewers and medical literature search associate • Literature screened from multiple external and client databases for risk benefit analysis • Aggregate analysis, risk-benefit assessment and medical analysis was performed by safety scientist and medical reviewer • Developed RMP templates and transferred the legacy RMPs with relevant sections updated • Successful collaboration for 3+ years • Conversion of over 100+ RMPs as per new EU PV legislation in 6 months • 75+ HA submission ready RMPs/REMS documents updated/ developed in one year. • Currently, multi-year engagement in place to support authoring and maintenance of RMPs and REMS

  7. Real-World Case Study 6. Safety Data Exchange Agreements Hybrid Delivery model 3 weeks Onsite Client training End-to-end SDEA development work Outcomes Business Need Solution • HA Inspection identified lack of SDEAs contractual arrangements with business partners • Support required for CAPA measures and roll out ~50 SDEAs in 3 months • Along with CAPA measure, client wanted BAU support in preparation and maintenance of SDEA ~100 SDEAs per year • Multi geographic COE setup for flexibility and time zone coverage • UK-based Program Director based, with offshore team of Safety Lead and five (5) Safety Associates • End-to-end SME support to assess master contract and partner PV capabilities, draft SDEAs, negotiate with stakeholders and finalize the SDEA for approval • Also involved in formal announcement of SDEA with effective dates to relevant stakeholders • Train-the-trainer approach implemented for offshore team. • Seamless integration with 100% off-shore team on-boarded to client system within a week of onsite training • Communication strategies, project management plan and tracker developed to ensure compliance to timeline • Fortnightly status report and monthly Governance meeting to review the progress

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