Job two: finding the right digital technologies for RA
Technology has come a long way since companies first started using spreadsheets. Today, developments in robotic process automation, artificial intelligence (AI), machine learning (ML), and natural language processing are revolutionizing industries in every sector. They're poised to have a true impact on RA, too. As regulators place more focus than ever on standardization, increasingly stringent data management becomes critical. While new laws are driving this push, a beneficial side effect for competitive pharma companies is improved productivity.
One technology that has already proven itself useful to RA, for example, is RPA. Many activities in RA lend themselves to this kind of automation because they're repetitive and rules based. Case in point: RPA can gather information from documents like summaries of product characteristics (SmPCs) for use in EVMPDs, or it can identify and extract updated 1572 forms for investigator submissions.
Meanwhile, AI and its subset, ML, are coming into their own in the RA realm as well. ML is the perfect tool for identifying the data you need from legitimate and up-to-date sources. It then extracts the appropriate material to help RA create items like a Module 3 baseline file of the most currently registered information.
The point is this: new technologies are disrupting traditional means of doing business. Not every new technology is appropriate for the RA function. But if practitioners keep an open mind about its possibilities, they can move out of the bureaucratic trenches and into their rightful place as full partners in the business.
With the right technology in place, a company can improve productivity and make its devices and medicines safer. It can hasten the time it takes to get new drugs to market. And it can spur growth by enhancing consumer trust and confidence.
And you have to admit: no spreadsheet can do any of that.