Good Vigilance Practices

Through Technology

Pharmacovigilance System

Maintaining a robust Pharmacovigilance system has become vital for Marketing Authorization Holders (MAHs) because of stringent regulations and increasing regulatory focus on patient safety and data security.

“Medicines and vaccines have transformed the prevention and treatment of diseases. In addition to benefits, medicinal products may also have side effects, some of which may be undesirable and / or unexpected. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.

All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before those are authorized for use. However, the clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time. Certain side effects may only emerge once these products have been used by a heterogenous large population, including people with other concurrent diseases, and over a long period of time.”
– World Health Organization (WHO)

Over the years, Pharmacovigilance systems have upgraded significantly through technology advancement. Introduction of artificial intelligence in Pharmacovigilance system has the ability to improve further through automation and intelligent decision making.

An ideal Pharmacovigilance application should be fully validated before implementation to ensure flawless execution, and scalable to enhance functionalities as per future needs and cost effective for better adaptability.

Our Expertise

We provide technical solution for Clinical Trial Safety and Post-marketing Pharmacovigilance Activities.

Pharmacovigilance System

While emulating technologies to expedite the safety analysis and reporting, artificial intelligence should be adopted in a stepped manner as artificial intelligence cannot replace human potential with evolving challenges faced with advancement in medical treatment modalities.

GVP technology can play a vital role in transitioning Pharmacovigilance system to technology enabled futuristic process and system ensuring the applicable regulations.

Industry Challenges

Although there are ongoing advancements in technology there are challenges need to be addressed carefully with adequate domain knowledge to ensure compliance with latest regulations and regulatory expectations.

Regulatory Requirements

Regulatory Authorities upgrade the regulations periodically to address gaps or introduce additional requirements for effective Pharmacovigilance system. Regulatory scrutiny and inspections have also increased in recent past. The changes in regulations in different countries create challenges for established Pharmacovigilance system.

Data Quality

Quality of data is crucial for benefit risk assessment of medicinal products. Since safety data are collected from different sources, it becomes more important to convert the data into structured format for analysis. Inaccurate handling of data results in erroneous assessment and interpretation, that can impact benefit risk profile.

Volume of Data

Volume of data is big challenge for database management. Handling of such large volume of data requires robust architecture for seamless operations. Improper handling of data and outdated technology can lead to erroneous outcome.

Data Integration

In Pharmacovigilance domain, the organizations use multiple applications or databases to record and store safety data for various purposes. Hence, database integration is crucial for flawless sharing and migration of data between databases.

Manual Process

Allocation of optimal resources for maintenance of effective Pharmacovigilance system.
Challenging to maintain good quality due to interpersonal and intrapersonal variability.
High volume of safety information increases workload.
High operational cost due to increasing number of FTEs.

Pharmacovigilance Application


Pharmacovigilance application should be scalable to adopt the requirements to comply with new regulations. It is required to implement additional features to address new regulatory requirements quickly and effectively to avoid non-compliance.


Pharmacovigilance application should be able to record, process, and store the data in a way that allows its accurate interpretation, assessment, and verification. The application should be able to handle large volume of data seamlessly.


A poorly designed application faces challenges because of compatibility issues that results system breakdown, shaky performance, data inconsistency, missing information etc. which eventually affect the data assessment and interpretation. The application should be developed with robust architecture to ensure flawless data flow and to avoid data integrity related issues.


Different types of technology are used for safety data collection from various sources throughout the product lifecycle. Sometimes, because of technological incompatibility, integration might be challenging which poses risk. Selection of technology in application development is crucial to ensure compatibility and data integration to meet the regulatory requirements.

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