AI Powered Pharmacovigilance CRO Services

Pharmacovigilance automation holds considerable potential for large-scale transformation, particularly during a period of heightened emphasis on safety and the reporting of adverse drug effects—fundamental aspects of pharmacovigilance. This automation represents a potent tool for enhancing literature search in pharmacovigilance, revolutionizing signal detection practices, and ultimately delivering superior pharmacovigilance services.

At Navitas Life Sciences, we specialize in Pharmacovigilance CRO services, offering comprehensive solutions tailored to meet your needs. With over 30 years at the forefront of Pharmacovigilance, our team of skilled Pharmacovigilance scientists excels in pharmacovigilance services, ensuring timely identification and management of adverse drug reactions. Leveraging cutting-edge Pharmacovigilance automation, we streamline processes to enhance efficiency and accuracy. Our pharmacovigilance consulting team has defined and implemented Pharmacovigilance processes, governance practices, and even organizations in more than 300 Life Sciences companies, making us a trusted partner for pharmacovigilance consultancy services.

In this blog, three Pharmacovigilance experts discuss various aspects of managing end-to-end PV services, signal detection in pharmacovigilance, adopting AI-driven solutions in PV, and more. Dr Pushpa Basavanapalli is the Director of PV at Navitas Life sciences responsible for managing end-to-end PV services and known for her ability to establish strong relationships with sponsors. V S N Raju Datla, as the Associate Director of Pharmacovigilance at Navitas Life Sciences, brings to the table extensive proficiency in processing, reviewing, and managing end-to-end PV services across clinical and post-marketing realms, encompassing ICSR handling, literature monitoring, aggregate reports, signal management, and RMP. Shabana Banu Shaik is a senior drug safety associate in PV operations at Navitas Life Sciences and possesses multiple years of experience in literature search in Pharmacovigilance and end-to-end ICSR processing. Shaik is fascinated by streamlining and automating global literature monitoring. Recently, these three experts collaborated on a new article titled "Automation of Literature Search and Review," which was published in Pharmaphorum.

V S N Raju Datla

Associate Director of Pharmacovigilance,

Navitas Life Sciences

How do you see the role of pharmacovigilance (PV) professionals evolving with the integration of technology in literature review processes, particularly in terms of managing end-to-end PV services?

When it comes to literature surveillance, we deal with big data. AI powered solutions can eliminate the unnecessary noise, duplication of articles in different journals, pick the relevant information and provide medicinal related safety information. This in turn helps in reducing the work stress on the Literature review professionals and helps them to focus on quality/scientific work, successively reducing the stress on PV professionals.

As someone with extensive experience in PV, how do you anticipate technology-enabled approaches impacting the efficiency and effectiveness of signal management within PV operations?

The literature tool enables you to scan large volumes of literature quickly and efficiently. It would extract relevant information from the abstracts, by highlighting the drug-event pair, thereby allowing for identification of signals or possible trends. It increases the accuracy of finding important and potential safety concerns pertaining to a drug or a therapeutic class. The literature tool can also be integrated with various signal databases which can facilitate assessment within one system.

Please share insights on the potential challenges and opportunities associated with adopting AI-driven solutions in PV?

The literature data covers adverse reactions associated with medicinal products and vaccines. Sometimes, there might be adverse events followed by vaccination or any medicinal products that are not common, different, and often unknown. So, analytics of any of this type can become challenging. The other one is language used by the authors in publication. There is a critical need to understand and interpret ambiguities and hence, careful curation is required. Moreover, very rarely, yet unexpected malfunctioning can happen any time which may lead to non-compliance with regulatory standards.

Learning is a continuous process. Reskilling and upskilling with technology can drive many opportunities in Pharmacovigilance. As rightly said “AI won't replace humans, but people who can use it will”. Partnering with reputable pharmacovigilance companies and leveraging pharmacovigilance consulting services can further enhance efficiency and compliance in this dynamic field.

Shabana Banu Shaik

Senior Drug Safety Associate in PV Operations,

Navitas Life Sciences

Please highlight the key benefits that AI-driven solutions bring to the process, especially in terms of scalability and adaptability to regulatory requirements?

There is immense data that must be screened during literature monitoring. As repetitive and time-consuming tasks are automated in AI-driven solutions, Pharmacovigilance scientists or professionals can focus on the relevant articles and submit the cases within timelines.

With your experience in literature monitoring and end-to-end Individual Case Safety Report (ICSR) processing, how do you envision AI tools improving the identification and reporting of adverse events from scientific and medical publications?

Expertise in Pharmacovigilance, coupled with technology solutions, can optimize the literature monitoring process, aiding in identifying and reporting adverse events effortlessly and effectively. This integration of skills and technology enhances the efficiency of pharmacovigilance jobs and operations.

Can you provide examples of how AI-powered literature monitoring platforms have enhanced the accuracy and efficiency of adverse event detection, thus contributing to the overall pharmacovigilance process?

As the AI tool is loaded with relevant terms, it can identify and trace the adverse event information in the articles making it easier for the specialists to decide the validity and reportability.

Dr Pushpa Basavanapalli

Director of PV,

Navitas Life Sciences

What is the impact of AI on resource utilization and operational costs within pharmacovigilance operations?

Switching to AI-based solutions enables the identification and resolution of inefficiencies, optimizing resource utilization by significantly reducing the manual hours required from pharmacovigilance professionals. This reduction in manual effort not only lowers operational costs but also minimizes lead time and eliminates waste, leading to a smoother workflow. Incorporating AI into pharmacovigilance CRO operations streamlines processes and enhances overall efficiency.

With your expertise in establishing strong relationships with sponsors, how do you think the adoption of AI-driven solutions in pharmacovigilance will influence collaboration and communication between stakeholders?

The AI platform can search multiple databases simultaneously, and the results are documented. Sponsors can access real-time adverse event information. Reconciliation and consolidated information can be provided whenever needed. User actions are fully auditable. This ensures trust between the sponsor and the pharmacovigilance CRO.

What are the potential benefits of AI-enabled literature monitoring platforms in terms of enhancing audit/inspection readiness and ensuring compliance with regulatory standards in pharmacovigilance?

No manual entering of data and hence, no room for errors. There is a track of all the user actions, and it is audit ready at any given point of time.

Automation of literature search and review

By V S N Raju Datla, Dr Pushpa Basavanapalli, Shabana Banu Shaik

• Learn about the benefits of automating literature search and review in Pharmacovigilance (PV).
• Explore how technology solutions can optimize PV processes, saving time and costs.
• Understand the advantages of integrating natural language processing technology in scientific literature review for PV.
• Discover a simple three-step approach to incorporating technology into PV literature monitoring workflows

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