top of page
Stanley Joel
Jun 123 min read

How to address the Pain Points in Case Processing?


Pharmacovigilance (PV) is a cornerstone of drug safety and public health, yet the process of case processing in PV is laden with challenges. These pain points can severely impact efficiency, accuracy, and regulatory compliance. Fortunately, Salvus, an advanced drug safety database, is designed to address these issues effectively. In this blog, we'll explore the common pain points in PV case processing, how Salvus addresses them, and the impressive results achieved by its implementation.


Pain Points in Pharmacovigilance Case Processing


1. Quality-Related Issues During Data Entry

Data entry in PV is susceptible to errors, including inconsistent data, incomplete information, and human mistakes. These quality issues can compromise the integrity of case data, leading to inaccurate safety profiles and potential regulatory non-compliance.


2. High Effort Consumption

The process of case processing is labor-intensive. Tasks such as data entry, narrative writing, coding, and assessment require significant manpower and meticulous attention, which increases operational costs and resource strain.


3. Timeliness in Case Processing

Meeting regulatory deadlines is crucial in PV. Delays in processing cases can lead to fines, compliance issues, and potential harm to patients due to delayed identification of safety signals. Ensuring cases are processed on time is a persistent challenge.


4. Volume Fluctuations

Pharmaceutical companies often face unpredictable spikes or drops in case volumes. These fluctuations can strain resources during peaks and lead to underutilization during troughs, making it difficult to maintain consistent quality and efficiency.


5. Case Migration

Shifting from one safety database to another involves complex case migration, which can be fraught with data loss, integrity issues, and downtime, disrupting PV operations.



How Salvus Addresses These Pain Points?

Salvus offers a comprehensive suite of automated features to tackle these pain points:


1. Automated Duplicate Check

Salvus employs sophisticated algorithms to automatically detect and eliminate duplicate cases, ensuring data integrity and reducing manual effort.


2. Automated Coding

With advanced coding capabilities, Salvus automates the process of coding adverse events and medical histories, significantly reducing manual effort and errors.


3. Automated Labelling

Salvus automates the labelling of cases, ensuring consistency and accuracy, and freeing up valuable human resources for more critical tasks.


4. Automated Narratives

Salvus generates comprehensive and accurate narratives automatically, reducing the time and effort required for this traditionally labor-intensive task.


5. Automated Follow-Up Generation

The system automatically generates follow-up actions and reminders, ensuring timely processing and adherence to regulatory timelines.


6. Automated IME (Important Medical Events)

Salvus automates the identification and management of Important Medical Events (IMEs), ensuring prompt attention and compliance with regulatory requirements.


7. E2B R2 & R3 XML Import

Salvus supports the seamless import of E2B R2 and R3 XML files, facilitating efficient case migration and integration with other systems.



Results After Implementing Salvus

Pharmaceutical companies that have integrated Salvus into their PV operations have reported significant improvements:


1. Improved Data Quality

By automating data entry and duplicate checks, Salvus has led to a 40% reduction in data entry errors, resulting in more reliable and accurate safety profiles.


2. Increased Efficiency

Automation of routine tasks has reduced the time and effort required for case processing, leading to a 35% reduction in Full-Time Equivalent (FTE) requirements and a 25% reduction in operational costs.


3. Enhanced Compliance and Timeliness

With automated follow-up generation and workflow management, companies are consistently meeting regulatory deadlines, improving compliance rates by 30%.


4. Better Resource Management

Salvus's scalable architecture ensures efficient handling of fluctuating case volumes, optimizing resource utilization and reducing operational strain. This has led to a 20% increase in profit margins by preventing resource wastage and improving efficiency.


5. Smooth Case Migration

Support for E2B R2 and R3 XML import has facilitated seamless case migration, reducing downtime and ensuring data integrity. Companies have reported a 50% reduction in migration-related issues.


6. Positive Impact on Patient Safety

Improved accuracy and timeliness in case processing have enhanced the early detection of safety signals, ultimately improving patient safety and public health outcomes.


In conclusion, Salvus addresses the critical pain points in pharmacovigilance case processing with its advanced automation capabilities. By improving data quality, increasing efficiency, ensuring compliance, and facilitating smooth case migration, Salvus has transformed PV operations, delivering substantial benefits in terms of cost savings, resource optimization, and patient safety. For pharmaceutical companies looking to enhance their PV workflows, Salvus offers a robust and reliable solution.


Interested to know more about Savus! Book a demo!




162 views0 comments

Comments

bottom of page