Without aligned improvements, R&D processes will never be optimal

For a whole range of commercial and strategic reasons, there is now enormous pressure on life science R&D organisations to hone their operational processes and make these as efficient as possible. Soaring cost pressures, downward pressure on pricing and margins, intensifying global competition, and increased product sophistication/complexity are all palpable drivers for change that are becoming increasingly impossible to ignore. Certainly, once the clock starts ticking on a new product patent, speed to registration and maximised sales potential are paramount. All of this is increasing the impetus to streamline core processes and then, in many cases, apply technology appropriately.Yet, today, across pharma Regulatory Affairs, Quality and Pharmacovigilance/Drug Safety functions, process rigour is dictated primarily by standard operating procedures (SOPs) and their evolution over time. SOPs are highly detailed, step-by-step descriptions of how things are done, to ensure a standardised way of working. Those SOPs are in most cases PDF versions of Word files, managed in an electronic document management system to ensure compliance. These snapshot definitions of processes do not, of themselves, foster efficiency nor effectiveness however.

Even where processes are improved and optimised over time, as long as these improvements are taking place discretely – within a single function or sub-area – the benefits are often confined to that immediate context and do not look at the overall, end-to-end process. Problems can commonly arise at points of handover. That could be between teams working in the same department, or as workloads pass between different functions (or potentially out to an external service provider, and then back again). If the interfaces where processes join inhibit seamless continuity or clear visibility, momentum can be lost and initial efficiency gains undermined.