Real-World Case Study
                                             1. Case Intake/Case Processing
         100% compliance to                        ~ 2000 cases                             24/7 contact Centre 
          timelines and quality                   processed per month
               Business Need                                 Solution                                 Outcomes
      Client was looking for a                  Dedicated team of PV Executives,         Met timelines - 100% for serious 
       comprehensive solution to                 Drug Safety Associates, Medical           case and >98% for non-serious 
       streamline case processing and            Reviewers, and Operational                cases
       drive productivity and compliance         Specialists                               Met quality ≥ 98% and regulatory 
      Heavy volume overload of ICSRs,           Dedicated call centre team to            submission compliance ≥ 98%
       aggregate reports and other safety        manage day-to-day case flow for           Rapid improvement in regulatory 
       documents                                 global and regional requirement (all      submissions and sustained 
                                                 EU Regions)                               compliance
                                                 Literature cases, spontaneous/ post-     Scope of work expanded to provide 
                                                 marketing  and legal cases                support in literature screening, 
                                                                                           authoring aggregate reports and 
                                                                                           other safety documents
     Real-World Case Study
                    2. Case Processing and Aggregate Report Quality Assurance Activities
         100% compliance to                                <0.2%                                          2-week
                  timelines                           inappropriate errors                             Transition period
                                                              flagged
                Business Need                                    Solution                                    Outcomes
       Client was facing quality issues with       Complete offshore CoE team of QA            100% compliance to turn around 
        case processing by existing vendor,          specialists for monthly 10% sample           time and <0.2% 
        and required a QA layer to manage            review                                       inaccurate/inappropriate errors 
        quality of ICSR                             All the findings were sent back to           flagged
       Expected QA activities included SOP          the originator vendor for root cause        3000+ data entry errors and 2000+ 
        compliance, reviewing sources                and CAPA                                     QC errors captured in ICSR
        documents, verification of case             Annual Volumes:  3000 ICSRs, 1200           100% CAPA tracked till closure
        receipt and creation date                    literature screening, 360 search 
                                                                                                 On-going QA support for ICSRs and 
       QA activity also included checking           check and 20 PBRERs                          periodic reports with dedicated  5 
        literature screening process output                                                       QA specialists
        and PBRERs
     Real-World Case Study
                                       3. CoE for Authoring Safety Documents
         100% compliance to                    Consistently <0.5%                                 >3000 
          timelines and Quality                        Errors/ page                               documents*
               Business Need                                Solution                                Outcomes
      Extended partnership model to            Deployed medical reviewer, senior       Entered into a multi-year contract 
       manage a number of safety                 authors, and a scientific editor;        with scope and volume expansion; 
       documents with the objective of           Authors took up end-to-end               team size increased to 25 resources
       driving overall productivity              responsibility for the assigned         Currently, in the 3rd year of 
      Engagement to be initiated as pilot       documents                                engagement, over 3000 
       project and encompassed authoring,       Created a 1-many hub to collaborate      simple/complex documents 
       updating, and quality checking            with multiple stakeholders across 15     authored and updated in the last 2 
       simple/complex medical documents          countries                                years
     Real-World Case Study
                                      4. CoE for Authoring Aggregate Reports
         100% compliance to                   Consistently <0.5%                                >3000 
          timelines and Quality                       Errors/ page                               documents*
              Business Need                                Solution                                Outcomes
      To expand pharmacovigilance             A team of reviewers and aggregate       Consistent positive feedback of 
       outsourcing initiative beyond case       report writers were deployed to          ‘Exceeds Expectation’ for quality, 
       processing to include the authoring      support aggregate report                 timelines, and communication
       of aggregated reports                    preparation for OTC and generic         ~90 reports were developed in 6 
      Scope included  call for coordination    products                                 months 
       for contributions, to author non-       Additional resources were deployed      The scope was expanded to include 
       safety sections of                       to support ad hoc request to author      authoring of all sections of 
       PSURs/PBRERs/PADERs, and final           addendum report and CO, SBRs, and        PSURs/PBRERs/PADERs, aggregate 
       compilation of reports                   commented line-listings                  report preparation for innovator 
                                                                                         products
                                                                                        Multi-year contract in place with 
                                                                                         average volume of 250 reports per 
                                                                                         year; team size increased to 15 
     Real-World Case Study
                                              5. Risk Management Plan
        100% compliance to                             <0.5                                    ~600
                timelines                         errors per page                         Products managed
              Business Need                              Solution                               Outcomes
      Develop/ update Risk Management        Deployed a team of senior authors,    Successful collaboration for 3+ 
       Plans (RMPs) for both innovator and    safety scientist, medical reviewers     years
       generic products.                      and medical literature search          Conversion of over 100+ RMPs as 
      Preparation of RMP: Aggregate          associate                               per new EU PV legislation in 6 
       Analysis, Risk-Benefit Assessment,     Literature screened from multiple      months
       medical analysis and medical           external and client databases for      75+ HA submission ready 
       writing                                risk benefit analysis                   RMPs/REMS documents updated/ 
      Updates to RMPs and REMS               Aggregate analysis, risk-benefit       developed in one year. 
       Medication guide                       assessment and medical analysis        Currently, multi-year engagement in 
                                              was performed by safety scientist       place to support authoring and 
                                              and medical reviewer                    maintenance of RMPs and REMS
                                              Developed RMP templates and 
                                              transferred the legacy RMPs with 
                                              relevant sections updated