#FutureReadyHealthcare
Top 50 Pharma Implements Best Practices for Streamlined Adverse Event Management and Efficiency in Pharma
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 efficiency in healthcare.
The Need: Best Practices for Adverse Event Management
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 compliance, cost standards and quality control in pharmaceutical
The Solution: A Compliant Medical Device QMS
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
Ready to optimizing adverse event case management and improve pharma efficiency ? Contact us now to explore innovative solutions tailored to your unique needs.