Pharma 4.0, quality management, sorting pills into tray
Drug Safety

Drug Safety and Pharmacovigilance in the Cloud is shaking up the Pharma Industry

- Elena Jimenez Gutierrez, Senior Business Consultant, NNIT

The use of cloud-based technologies, services and tools enables most life sciences companies to accelerate their digital transformation in drug safety and pharmacovigilance (PV). Learn how to leverage the cloud to streamline drug development, drug safety and signal management.

The life sciences industry has witnessed a significant shift towards cloud-based drug safety database platforms that facilitate collection, processing, analysis and reporting of adverse event reports.

Most life sciences companies face an urgent need to adopt new technological capabilities and modernise business strategies, models, and solutions to support drug development and safety surveillance. By embracing cloud technology, life sciences companies can achieve more streamlined and data-driven drug safety processes while consistently improving patient care and support.

Cloud computing empowers digital transformation by providing a platform that is much more scalable, cost-effective, secure, and efficient at managing vast volumes of data, automating critical processes and maintaining systems.

– Drug safety and PV are among life sciences’ most challenging and complex business areas due to the high impact on patient health risks. Accurate reports, evaluated signals and informed decisions must be captured promptly to secure quality, safety and compliance throughout the whole product lifecycle, says Elena Jimenez Gutierrez, Senior Business Consultant, Safety Consulting at NNIT. She continues:

– Most pharma companies are experiencing exponential growth in data due to the increasing complexity of conducting clinical trials and ever-changing regulatory requirements for pre- and post-marketed products. Therefore, the cloud’s improved scalable architecture, AI-enabled services and advanced analytical tools are powerful platforms and enablers for more sustainable research and development. We’re currently facing a much higher demand for the cloud than on-premises, says Elena Jimenez Gutierrez.

Improving efficiency and compliance

Once a product is on the market, a massive quantity of individual case safety reports are available from multiple sources in both structured and unstructured data formats. Hence, continuous monitoring of spontaneous reports is essential for effective signal detection and management.

This includes identifying safety alerts and signals using external databases as sources besides the company’s core safety databases, e.g. the World Health Organization’s (WHO) VigiBase, the FDA Adverse Event Reporting System (FAERS) and the EudraVigilance Data Analysis System (EVDAS). Additionally, use of Real-World Data (RWD) and Electronic Health Records (EHR) are also in the horizon, and these will surely revolutionize signal identification.

To improve signal detection, cloud-based safety platforms provide tools for data mining, visualization and business intelligence. If the signals are valid, they still need comprehensive evaluation to provide additional information for risk management.

Cloud-based safety systems also excel at addressing data privacy concerns that align with regulations such as 21 CFR and GDPR. This encapsulation of compliance measures within the vendor's product development further eases the resource burden on pharma companies.

– Pharma companies are increasingly adopting compliant cloud-based safety applications, reducing the burden of compliance. These applications save a lot of effort because the vendor handles the quality and compliance framework. This means that cloud-enabled tools allow businesses to optimize resources and reduce costs while improving patient safety, says Elena Jimenez Gutierrez.

The future belongs to cloud-enabled tools

Depending on the cloud vendor, different software components are at play when considering a cloud platform. However, many include advanced options for analytics and AI, and they encompass multiple modules ranging from signal management to gateway interchange.

– We’re entering an era of more AI-based cloud computing in which we integrate data science with more intelligent predictive analytics. In 3-5 years, AI will be an integral part of every cloud system, but even now, many tools already effectively manage and analyze safety cases in quantitative methods, says Elena Jimenez Gutierrez.

Modern cloud-enabled architectures are equally effective when sharing data across different business areas.

– A unified single platform enables quick access to a single source of data internally within the enterprise, or externally. By having one platform in the cloud to manage your pharmacovigilance, the burden of drug safety is considerably reduced, says Elena Jimenez Gutierrez.

Choosing the right solution

While most businesses in life sciences are already in the cloud, some companies maintain their databases on-premises due to complex integrations, highly customized legacy systems or other feasibility concerns. According, to Elena Jimenez Gutierrez, considering the options carefully is vital for success.

– Switching to the cloud is no easy task. Feasibility studies including data quality reviews are crucial to determine the efficiency of cloud solutions and which systems or vendor partnership is suitable for your business. You need in-depth knowledge about end-to-end business processes and a certain technical proficiency to be able to make the right choice, says Elena Jimenez Gutierrez.

– There are multiple factors and decisions to consider when selecting the best technology foundation for your specific business. At NNIT, we’re well adept at drug safety and PV from an end-to-end perspective, in data quality as well as in system testing and validation during implementation, support and maintenance of any safety platforms whilst constantly innovating new strategies, solutions and automations. We can always help you make the best choice for your needs and assist you throughout your digital transformation journey.

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Interested in how NNIT can help you leverage the cloud to improve drug safety? Feel free to contact us with any questions.