1. REAL WORLD CASE STUDY

2. ~ 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

3. 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: ICSRs, 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 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. 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

5. 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

6. 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

7. 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