Today, empowered patients and increased attention to drug safety have made pharmacovigilance more essential than before. Besides, the traditional pharmacovigilance process is highly manual and resource-intensive. As a consequence, pharmaceutical industries require deploying more robust processes and systems to detect, assess, report, and prevent adverse effects.
When it comes to accumulating information on adverse events (AEs), it starts right from clinical trials and continues even after the drug's market release. AEs are reported across the globe in different languages and formats. Some are structured or unstructured, whereas others can be reported as hand-written documents. Moreover, this data comes from multiple data sources – distributors, affiliates, partners, and even patients.
Estimates put that a huge pharma company receives 300,000 to 500,000 adverse events in a year. Large teams analyze these documents manually, identify the relevant information, and then enter them into the safety system. This data is followed by quality and medical review and later submitted to regulatory bodies.
With increasing patient awareness, regulatory pressure, and emerging data sources, there will be an exponential growth in data volume. Thus, pharmaceutical companies require shifting their focus from manual data entry to proactive management. With document automation technologies, pharma companies can decrease their efforts, time, and resources spent on manual data assessment; thus, freeing resources to concentrate on more crucial PV activities.
When it comes to creating a stack of documents every day, there is no doubt that it is painstaking and takes up a lot of time. But what if there is a way that could make this process easier and faster? Well, this is what document automation comes up along with a host of other benefits. Yet, many pharma companies deny from taking up such benefits, thinking that document automation cannot generate complex documents, it might require specialized training to learn how to use it, or it is too expensive for their organization.
But, with varied data sources and immensely growing PV data, it is high time pharmaceutical companies bust these myths and adapt to the most efficient document automation systems.
Once deployed, the document automation system will reduce manual efforts by 70-80%, while ensuring zero data entry errors. Besides, it eliminates time-squandering processes like data extraction, data entry, document generation, and report creation, ensures accuracy, and saves money.
There are a lot of processes involved in pharmacovigilance from the collection of Adverse Events, processing, signal generation, and more. It takes up a lot of human resources, money, and skilled management. As pharmacovigilance must have minimum errors, quality workforce and management are crucial. Document automation in pharmacovigilance circumvents the need for human resources. As most of the tasks performed are repetitive, they can be automated.
Employing document automation in data processing will not only reduce costs but also accelerate the processing. Moreover, it will eliminate the risk of human error while improving quality and accuracy. This can help PV industries establish a robust pharmacovigilance system that utilizes modern technology to capture and analyze new data sources. The document automation system thus enables pharma industries to automate the extraction of data and the process of reporting.