A recent report by the American Medical Association stated that as many as one out of three drugs in the US market might have safety issues. In 2017, the European Medicines Agency (EMA) had also reported that about 200,000 lives would have been saved had safety issues with drugs been addressed on time. While these developments underline the need and importance of stringent pharmacovigilance, they also necessitate the implementation of an automated solution to improve the accuracy and efficiency of safety case intake and processing activities. This will help minimize manual errors in reporting adverse events and enable pharmaceutical companies to meet regulatory requirements faster than before and cost-effectively.
Implementing a Touch-Free Cognitive Automation Pharmacovigilance Solution
The first step toward implementing a full-scale pharmacovigilance solution is to successfully execute a pilot for customers that would demonstrate the viability of cognitive automation. It is also imperative to incorporate a collaborative program management structure that mirrors roles within the pharma organization and the technology partner across all workstream levels.
The range of activities within program management that help shape a concept into a full-scale production implementation are:
Scheduling meetings to exchange progress information, communicate constraints, and obtain periodic guidance from project sponsors.
Maintaining production readiness of the cognitive solution, especially when the program involves a 'bespoke' solution using a 'novel' technology for which the regulators issue no validation guidelines, and no best practices exist in the industry.
Introducing a step-change in program management when many individual and mutually exclusive threads (i.e. workstream levels) get tangled.
Considering a course correction to formally introduce the ‘workstream’ structure in the program.
Nominating leads from technology and customer organizations for each workstream and entrusting them with an independent charge to pursue activities within their workstream purview and reporting to a larger team and program managers at least on a weekly basis.
Ensuring focused discussions between individuals excelling in a given domain and consensus-based decision making. The program managers are responsible for creating a ‘coherent’ view at the program level.
Emphasizing on one of the essential pieces in the pharmaceutical automation journey, i.e. business analysis. This ensures that the technology solution providers employ cognition to automate the most efficient process as against automating the existing process, which may not be conducive for automation.
Digitizing applicable documented business conventions, protocols, and procedural steps to facilitate cognition. Besides, program teams should conduct multiple simulations of ‘what if’ scenarios to ascertain if every facet of business operations and scenarios have been evaluated in this pharmaceutical automation journey.
A key validation tenet for any technology partner is to ensure 'anytime inspection-ready state' of its solution. This is vital since, as a technology provider, it can extend the benefits of thought leadership. To meet this goal, a detailed set of in-house activities need to be identified. And as a natural extension, an exhaustive list of procedural documents has to be either created or updated to support the new and niche manner in which business operations are conducted. The program team can empower the Good Pharmacovigilance Practices (GVP) validation workstream members to identify the extent of changes required to support business operations. All documents can be classified as product-related and implementation-related. The technology provider can also collaborate with customers for reviews, updates, and approval of implementation-related documents within the stipulated project timelines.
The Way Forward
Implementing a cognitive pharmaceutical automation solution or automating identified business processes with cognitive/artificial technology is a process akin to a thousand moving parts. When synchronized together, this becomes a movement within an organization to embrace innovation. On the flip side, poor management can lead to severe setbacks that will be detrimental to the program. The unifying cord that holds all intricate processes together is the project plan and the project manager of the technology provider. The latter is responsible for creating a detailed project plan along with the customer's project manager to provide an insight into the activities on the critical and non-critical paths. All workstream meetings should begin with progress updates, followed by a discussion, and conclude with a review of the project plan and updates, thus keeping all stakeholders, including the sponsors, abreast with the pace of the program and readiness for any unforeseen issues.