Client Background

• One of the top 5 global pharmaceutical companies
• Present in APAC, EU & US regions

Challenge

The Client required services related to end-to-end case management that included timely regulatory submission for all case types. The inability to submit cases on time led to non-compliance and critical audit findings by regulatory authorities. Further, the quality of completed cases were not above 95%, which was a criterion to meet regulatory compliance. This impacted both business revenue as well as overall product lifecycle.

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91¿ì»îÁÖ provided end to end case management services from receipt to timely submission of serious and non-serious cases received from different sources in unstructured formats. To this end, we adhered to all Quality checklists and maintained close communication with internal and external stakeholders for data collection and verification. We ensured:

1. Introduction of Standardized Operating Procedures (SOPs) and a centralized process. This helped develop internal competencies for case processors who were processing serious and non-serious cases
2. Online process and quality checklist was introduced at each step of ICSR workflow to avoid multiple iterations and duplicate checks. This resulted in timely submission to global regulatory authorities
3. SLAs and metrics were stringent and transparent to achieve >98.75% quality for all cases 
4. 100% turnaround time ensured that the Client was able to submit all cases on time without any delay or product recall 
5. Triaging of serious cases were completed by Medical reviewers ensuring correct evaluation and assessment of cases at initial stage resulted in meeting SLAs

Business Impact

1. Cost Containment - Around 65% reduction in overall operational cost achieved through economies of scale
2. Compliance - 100% compliance adherence
3. Scalability – Improved average handling time (AHT), resource optimization, case allocation, training compliance, and digitization. Reduced manual efforts optimized seat utilization through resource planning tool
4. Operational Efficiency -  Significant improvement in volume, quality and turnaround time due to process standardization/ Centralization
5. Regulatory Adherence - 98.79% of submitted documents were approved and accepted by health authorities