Raising the bar in pharmacovigilance and regulatory outsourcing
It’s all too easy to underestimate the importance of tight project management when the work being outsourced is something other than clinical trials. Yet, whether the processes involved concern international pharmacovigilance or regulatory information filing, Anna Lukyanova, COO of Arriello, warns life sciences firms not to leave outcomes to chance.
Keeping strict control over quality, process, resourcing, data management, audit trails and cross-party communications is essential to the success and credibility of outsourcing outcomes, and critical to the management of costs, and containment of risk. This is true not just in a clinical trials context, but for all engagements.
In a research context, the value of tight project management is self-explanatory when entrusting the operations to a third party. Yet when it comes to more routine requirements, biotech and pharma organisations tend to lower their expectations. For (PV) pharmacovigilance, or regulatory submissions and associated information management, firms’ priorities typically revolve around specific technical capabilities and capacity, rather than how the engagement will be coordinated and delivered. If the brief is to deliver pharmacovigilance operations for 30 countries, for instance, the chief aim will be to ensure the partner organisations has PV experts in sufficient supply.
But if there is inadequate provision for coordinating all of the various stakeholders (including business development people, technical teams, IT, external vendors, contract/procurement departments, HR and even accounting and finance), any number of issues could emerge which could lead to project scope creep, missed deadlines, exceeded budgets and more.
Adapting to changing requirements
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 is important, too, to have an accountable individual or team in place to monitor changes to the requirements of the service, or any other factors that have influenced throughput and the ability to deliver as expected.
Assigning technical experts to the project management role rarely goes well. The pressure to keep everyone in the loop, progress action plans with individuals, and handle issues wherever these emerge, can overwhelm someone not primed for the role. In some cases the stress of project coordination has led to good people leaving their job.
In a regulatory submissions context, it’s particularly easy to downplay the project management role. Where the assignment is ‘simply’ to file documents on time, life sciences firms and even their service provider partners might question how a project manager could add value. 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.
Seeing the bigger picture
A good project manager will also be primed to think outside of the box, not looking solely at the immediate requirement and the job specified, but also at process interdependencies. They will also be proactively scanning for potential for more efficient ways of working, or strategic automation - where it could help to expedite delivery and contain long-term costs, even as workloads grow.
In relation to regulatory submissions filing, the broader remit might include staying ahead of evolving updates or additions to regulators’ demands. In a PV context, it may involve identifying the potential to automate translations of international case reports, with a view to greater efficiency and reporting consistency. Technical experts, focused on the immediate task in hand, wouldn’t necessarily take this broader view.
And of course among the expected benefits of using an external service provider is not just the ability to draw on superior economies of scale, but also access to best-practice approaches to delivery. A project manager, with a higher-level view of operations, is in an ideal position to distil 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 the additional value they bring to the table can pay dividends.
As compliance demands escalate and inspections become more commonplace, firms must also be prepared for anything. Sharing this burden with a trusted provider can bring reassurance that all is as it should be, and nothing has been left to chance, something any decent project manager will have under control.