Anna Lukyanova, Chief Operating Officer of Arriello, identifies the importance of not leaving outsourcing outcomes to chance.
When biotech and pharma organisations outsource activities that are seemingly less ‘critical’ than the running of clinical trials, it’s too easy to neglect the importance of tight project management and stakeholder coordination to keep delivery on track. Whether the processes are around international pharmacovigilance or regulatory information management and filing activities, it is essential to ensure that outsourcing outcomes are not left to chance.
“Firms need to be ready for anything as they plan and process their workloads and fulfil their obligations”
In a clinical trials context, the need for tight project management is self-explanatory, especially when entrusting the operations to a third-party research organisation. Keeping strict control over quality, process, resourcing, data management, audit trails and cross-party communications is essential to the success and credibility of outcomes, the management of costs, and the containment of risk.
But move outside of clinical research, and biotech and pharma organisations quickly become more lax in their expectations of formal project management. If they are outsourcing processes such as pharmacovigilance or regulatory submissions management, firms’ chief priorities tend to be buying in particular technical prowess and access to scalable resources, placing all emphasis on the relevant technical expertise and capacity of the teams they are engaging.
Yet this preoccupation with the technical logistics can come at a price. While it goes without saying that service providers must be expected to field qualified talent with relevant experience of processing the given type of work, these qualities alone do not guarantee an optimum and tightly managed engagement. Trained scientists don’t necessarily make for natural project managers or communicators, so there is always a risk that the ins and outs of successful process coordination could suffer if there isn’t a designated person or team to bring all of the different strands together.
Often the project originator may underestimate what’s involved, as what seems to be a straightforward process is transferred to the outsourced service provider. If the brief is to deliver pharmacovigilance (PV) case reporting for 30 countries, for example, their primary objective will be to identify PV experts in sufficient supply. But by neglecting to vet the surrounding provision for coordinating ongoing communication with internal and external stakeholders (including business development people, technical teams, external vendors, contract/procurement departments, HR and even accounting and finance), any number of issues could emerge which – unchecked – could lead to project scope creep, missed deadlines, exceeded budgets and more.
No matter how well defined an initial project is, requirements and other parameters will frequently change across the delivery lifecycle. Ideally most of these variables will be planned for upfront as part of a risk assessment, and resources calculated to allow for potential peaks and troughs of demand. But it will be critical to the smooth running of the project that an accountable individual or team has their finger on the pulse, monitoring for changes to the requirements of the service, or any other factors that have influenced throughput and the ability to deliver as expected.
Expecting technical ‘do-ers’ to step up to the project manager role is unrealistic. This is something that happens routinely, but typically with unwelcome results. The pressure to coordinate stakeholders, keep everyone in the loop, push forward action plans with individuals, and handle issues wherever these might spring up, can overwhelm someone not primed for this role. In the worst cases it has led to those people leaving their job, at which point stakeholders might finally realise that complex engagements might even need a team of project managers to keep all the strands together.
The importance of the project manager role may be further underestimated further in a regulatory submissions context. Assuming the assignment is ‘simply’ to file documents on time, life sciences firms and their service provider partners might question where the role is for a project manager. Yet managing the transfer of a remit from the process owner to a third-party service provider, especially if multiple business entities, locations or regulatory jurisdictions are involved, needs to be meticulously organised.
The helicopter view
A project manager will be primed to think outside of the box, not looking solely at the immediate requirement and the job specified, but at process interdependencies. If they are doing their job well, they will also be proactively scanning for scope to introduce more efficient ways of working or strategic automation – where it could help to expedite delivery and contain or reduce long-term costs, even when work volumes spiral.
If the immediate project is international regulatory submissions filing, for instance, the broader remit might include staying ahead of evolving updates or additions to regulators’ demands – which can be hard to keep track of without a dedicated, coordinated focus. In a PV context, the expanded role may involve exploring opportunities to streamline and automate translations of international case reports, towards greater efficiency and reporting consistency. Technical experts, focused on the immediate task in hand, wouldn’t necessarily take this broader view.
Among the expected benefits of using an external service provider is not just the ability to draw on superior economies of scale (because the investment of skilled resources and advanced technology aids can be shared between multiple clients); there is also the potential opportunity to access best-practice approaches to delivery. A project manager with a higher- level view of operations, is in an ideal position to distill key learnings from across multiple engagements, so that all clients are better off.
There may be an additional charge for having the advantage of a project manager as part of a business process outsourcing engagement, but typically the value they bring to the table – not least in identifying additional scope for efficiency and service improvements – can pay dividends.
As compliance demands grow and become more bureaucratic, and as regulatory audits and inspections become more commonplace, firms need to be ready for anything as they plan and process their workloads and fulfil their obligations. Sharing ownership of these activities with a trusted provider can bring comforting reassurance that all is as it should be, and nothing has been left to chance, which by no coincidence is the mantra of every good project manager.
Anna Lukyanova is Chief Operating Officer of Arriello. Go to www.arriello.com