REAL WORLD CASE STUDY

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

inappropriate errors flagged 100% compliance to timelines Real-World Case Study 2. Case Processing and Aggregate Report Quality Assurance Activities <0.2% inappropriate errors flagged 100% compliance to timelines 2-week Transition period Business Need Solution Outcomes 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

100% compliance to timelines and Quality Real-World Case Study 3. CoE for Authoring Safety Documents Consistently <0.5% Errors/ page 100% compliance to timelines and Quality >3000 documents* Business Need Solution Outcomes 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

100% compliance to timelines and Quality Real-World Case Study 4. CoE for Authoring Aggregate Reports Consistently <0.5% Errors/ page 100% compliance to timelines and Quality >3000 documents* Business Need Solution Outcomes 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

100% compliance to timelines Real-World Case Study 5. Risk Management Plan <0.5 errors per page 100% compliance to timelines ~600 Products managed Business Need Solution Outcomes 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

Onsite Client training Real-World Case Study 6. Safety Data Exchange Agreements 3 weeks Onsite Client training Hybrid Delivery model End-to-end SDEA development work Business Need Solution Outcomes 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