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Indegene

Top 50 pharma optimizes adverse event case management with best practices and efficiency improvements

The Customer

A top 50 global pharmaceutical company had grown its portfolio through product acquisitions from other pharma. While consolidating safety systems, the client realized the processes for different products and teams remained disintegrated and non-uniform.

For the customer, it was imperative to standardized the processes across different products for better quality, compliance and efficiencies.

The Need

Client wanted to carry out a study of the end-to-end process of adverse event case management to understand current practices, nuances, and best practices being followed

With that knowledge, the client wanted to

Standardize ways of working

Ensure that investments in safety systems accrue to every product

Adopt best practices across the products

Measure and monitor performance of different teams against defined quality, compliance and cost standards

The Solution

Indegene deployed its proprietary Indegene Pharmacovigilance Maturity Framework for in-depth process study and benchmarked client’s processes against industry best-practices

We arrived at maturity levels of individual product processes with a data and evidence-based approach and identified the gaps

We used parameters such as the extent of manual effort/ steps, quality guardrails adopted, training methods & resource expertise, monitoring methods, etc. to arrive at the maturity score

In re-drafting ways of working, SoPs and work instructions, we created best practices such as 'Risk-based tiered case processing' and 20+ parameter governance models

Example gaps

Common pitfalls first approach for better QC coverage

Inadequate guideline for combination product coding

Narrative for solicited cases inconsistent in required detail

Outcomes

20%

Jump in quality & compliance score for particular products

>35%

Efficiency gain from low touch approach to low-risk cases

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