In the realm of pharmacovigilance, is the cloud solution the latest development?
- New technology and systems support every aspect of the drug development process, which is changing exponentially.
- Before biological products are submitted for market clearance, pharmacovigilance (PV) is one of the most important steps in the medication development cycle. It makes sure that the products fit the intended safety profile.
- One of the innovative and promising developments aimed at enhancing the PV process as a whole is cloud-based solutions.
- Before being approved for commercial use, all biopharmaceuticals go through extensive clinical trial testing to ensure their safety and effectiveness. The three components of PV are systems, operations, and surveillance. It is a comprehensive process.
- To ensure that safety is upheld, PV requires significant data entry and analysis. It also looks for adverse events (AEs) that have not been discovered yet or for variations in the severity of AEs that have.
- The industry is working to address several major issues that persist despite the process’s significant advancements.
- These issues include more consistency in reporting adverse events, difficulties with spontaneous reporting, the preference for efficacy over safety, constraints on presented reports, analysis of digital medical records, and combining systems.
The industry’s present obstacles
One problem that arises in clinical practice is the inconsistent reporting of adverse events. Because adverse effects can happen even days after taking a medication, people may not always recognize them at the time and may not appropriately report them to a healthcare provider.
This is critical information for the pharmaceutical company since it may point to a possible problem with the drug’s safety, particularly if a certain adverse event is reported frequently.
The number of adverse event cases is increasing in tandem with the complexity of the disease, creating a challenge in the development of a therapeutic that is both efficacious and has a suitable safety profile.
The industry is currently facing a special problem with system integration, as many organizations find it difficult to incorporate new technologies like cloud computing into their established systems. To guarantee high-quality signal analysis, it is essential to standardize medical domains, signal definitions, adverse events, and medical coding. Regrettably, system integration is still difficult because there isn’t a common framework.
Systems designed to identify adverse events (AEs) are receiving real-time data from telehealth devices such as social media and activity bracelets. As more and more organizations use telehealth in their research, new information sources are being introduced. To develop the advanced analytical tools needed to assess the data’s worth, new PV protocols will be needed.
There will continue to be a need for more PV capabilities in the future as the global rules continue to get more complicated. In nations with developing regulatory environments, policies will be codified and adapted accordingly. This is according to an industry report.
The field of pharmacovigilance is changing due to rapidly advancing technology and shifts in the delivery of healthcare worldwide. As a result, many organizations are having to incur substantial costs for system upgrades and maintenance.
The industry has since changed as a result, and many biopharma companies are now thinking about how new technologies and advanced analytics could enhance their current PV systems.
PV technology of the future
Many pharmaceutical companies are now placing a high premium on developing next-generation PV systems to lower costs while simultaneously enhancing patient safety, which is of utmost importance.
It has been observed that a new system ought to have the following four essential elements:
• Intellectual case processing to help increase the effectiveness and caliber of the AE life cycle by automating data input and processing.
• Operational and aggregate reporting that is scalable, easy to use, and built to handle big data sets and high-volume usage.
• Signal detection, assessment, and management that combine and simplify systems and procedures to enable analysts to carry out validation and assessment tasks without ever leaving the system, resulting in more accurate and efficient data management.
• Safety measures that find benefits that can enhance patient outcomes while detecting, evaluating, and assisting in the prevention of safety-related problems. These metrics make use of newly developed real-world sources, safety data that already exists, and supervised and unsupervised machine learning.
Solutions leveraging the cloud
Cloud-based solutions represent a novel approach to pharmacovigilance assistance.
Pharmacovigilance has several benefits, one of which is the ease of upgrading systems. Every time new developments in technology or modifications are made to drug safety regulations, systems that evaluate data on drug adverse events (AEs) are automatically updated to comply with the new requirements.
Upgrades to on-premises safety software are regarded as very expensive and oftentimes time-consuming, which can create company disruption. Pharma organizations can greatly benefit from this.
One other benefit of using cloud-based technologies in PV is that it makes data integration easier. Traditional PV systems require manual data transmission to an external solution.
As technology has advanced over the past few years, cloud-based PV solutions have become more and more popular. It has been observed that incorporating cloud technology can facilitate healthcare professionals’ access to medication safety information, regardless of whether the data was reported during clinical studies, in addition to the pharmaceutical business.
