A good information management platform for PV reduces the scope for human error and allows certain aspects to be automated. This saves cost and man power for companies; one of the main benefits of this is that it enables them to refocus their resources on other functions such as R&D. Moreover, in certain companies, product portfolios can be disorganised which can further affect compliance, efficiency, and finances. It can also compromise the ultimate goal of the pharmaceutical industry: the safety and the health of patients.
Despite its huge importance, there are many difficulties in managing pharmacovigilance complexities in a single system. Pharmacovigilance is a multi-faceted process, and there are several ongoing tasks such as maintaining the labels, paying various fees and having traceability of safety information across markets. General changes contribute to the difficulties in managing pharmacovigilance, for example the increasing prevalence of chronic diseases which require patients to take a combination of drugs. This complicates the issue and means that maintaining clear and accessible records for every drug is more important than ever, as healthcare professionals need to be able to see all the information about a single drug and how it interacts with others.
There are many ways in which this process can be greatly simplified, namely having adequate software which allows users to manage pharmacovigilance. So, what are the main requirements? Automation is one of the umbrella trends, this makes the business processes of PV much easier (reducing the level of manual data input required) and thus less susceptible to human error, as well as faster. PV requires management not only of data but associated content in a secure, version controlled and re-usable manner. Information about adverse events comes from a number of different sources and gets used in multiple output ways (safety reports, service level agreement reporting, updates to regulatory content), so the software requirement is a single platform which can bring all of them together and report on it in a way which is clear and accessible.
As a full end to end platform, CARA actually resolves many of the issues associated with managing Pharmacovigilance. One particular benefit is the ease of traceability from case data to associated documentation and reports, this facilitates having numerous open cases for a user. CARA also makes versioning simple so that the users can easily see the progress and different stages, in one place. Integrated workflows are another huge benefit of using CARA. And while CARA is available on premise, it is the cloud version on a SaaS model which is a huge benefit to customers in life sciences as it limits the need for extra workforce and expensive imposed upgrades.