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.
Extending benefits beyond the joins: an end-to-end approach to improvement
Where companies take a more holistic view, which places the focus on the output of processes and the goals this is designed to serve, there are multiple gains on offer. These range from true improvements to overall efficiency, as well as new clarity about roles and requirements within each process. These developments, in turn, can inform new IT systems implementation, as well as outsourcing arrangements – ensuring that these deliver maximum value. It makes good business sense, then, to review and optimise processes on a broader scale.
Fuller process transformation requires a more extensive review of what is going on, on an end-to-end basis. Without that, the potential benefits will always be compromised.
What is holding companies back in their process ambitions?
So why hasn’t more progress been made, given the scope for holistic process improvement? What is holding back pharma R&D organisations from being bolder and more innovative in their process transformation?
Culturally, some reservations are linked to an instinctive fear of extended transparency, especially during inspections. Where processes are viewed, treated and managed more holistically and continuously across the traditional boundaries or departmental divides in a process management suite, there may be concern that inspectors might extend their curiosity and raise their gaze when reviewing current procedures. This concern is heightened where companies use business process management (BPM) suites to represent their entire process landscape within a single system (with the risk that inspectors can freely “jump” from one process to another). Yet, if processes have been well-defined and are running smoothly, in a closely-tracked way, the ability to see all of this at a glance is a positive development.
More practically, it is the lack of clear process definition (beyond the scope of individual SOPs) that is the greater sticking point. It is only when process owners and process ‘customers’ (those on the receiving end of the output) are agreed on what a good process looks like that this knowledge can be applied effectively to streamline it. This is because, in many cases, there has been a loss of sight of the deliverables of processes, and who and what they are designed to serve – beyond inspectors’ satisfaction that no corners are being cut; that procedure repeatability is ensuring the highest standards of quality, safety and regulatory compliance of a created output. If the output is ultimately wrong, for instance, any gains in ‘throwing it over the wall’ more swiftly will be lost. If the output is a document (e.g. part of a regulatory dossier) which fails to meet the requirements, it will be sent back to the author – creating a costly and timely rework cycle.
Another common fear of investing in real process change is linked to concerns about the likely resources this will consume, both financial and in terms of people’s time – potentially detracting from business as usual. As long as process reviews and transformation plans are designed for and adapted to the particular needs of the organisation, the justification for the improvements become clear and these barriers to change are soon brought down.
Converting inertia: strategies for moving forward
True process improvement, especially end-to-end transformation across an extended environment, needs to start with clear, ideally in-person communication between the main parties involved – the process owner(s), process participants and the process customer(s). The goal of this should be to identify the most efficient process to create the output as expected by the customer leveraging experiences where repeated issues emerged in the past (e.g. repeated pushback, rework cycles.
Alongside, or to help provide a focus for, discussions about scope for process improvements, process stakeholders can harness intelligent “process mining” tools to identify common bottlenecks and repeat loops.
The greater the scope of the process elaboration, and the broader the range of stakeholders, the greater the timescale needed to evaluate, redesign and optimise the new agreed scenario.
Again, staying focused on the common goals will be important – such as improved and more effortless compliance; greater clarity for all parties about what is needed, when and why; and the scope to alleviate resource pressures through the targeted automation of labour-intensive tasks using appropriate technology (e.g. modern RIM capabilities).
The pay-off – clearer roles, user requirements, and training pathways
Once good, streamlined and aligned processes are in place, teams can pull this content and create SOPs. Clear definition of process roles (“swim lanes”) meanwhile can help identify the specific activities linked to them. This in turn could be used to inform role-based training, for the individuals fulfilling the processes.
Ultimately, good process elaboration, oriented towards the process customer, enables greater operational efficiency. It also makes it much easier to introduce new technology systems and features, since well-described processes inherently force robust descriptions of user requirements. Certainly, no business ever suffered from having a better understanding of its end-to-end processes. By contrast, where a lack of clarity persists – of how process output and any efficiencies gained will flow back into the company and be harnessed by adjacent teams or functions – the scope for transformation (at any level, let alone inter-department process streamlining) will be significantly compromised.
At a time when data-based transformation and intelligent automation (harnessing AI) register highly on pharma R&D digital transformation wish-lists, the scope for associated process review cannot be ignored. IDC is just one of the major technology analysts pointing to the need for deeper, more fundamental capability shifts in 2025, for organisations in all markets. It points to the move toward a “data-as-a-product” architecture (a way of producing and consuming data that makes processes repeatable and data-enabled outcomes more consistent and reliable) for all major enterprises (1). Delivering and optimising this kind of setup will demand a full process review as much as a breakdown of data silos and the disconnections these cause.
References and notes
- IDC Unveils 2025 FutureScapes: Worldwide IT Industry Predictions, IDC, October 2024: https://www.idc.com/getdoc.jsp?containerId=prUS52691924
