The global-local continuum: tips for a joined-up approach to Regulatory & PV outsourcing

Local affiliates are arguably just as in need of outsourcing support as primary pharma locations. But drawing on such services should be frictionless, and involve close coordination with the vision and goals of HQ. Anna Lukyanova COO of Arriello, explores where biotech and pharma firms can go awry in their international service use, and offers tips on how to ease the transition for all. 


n a global market, where speed of delivery, agility and cost-efficiency are high priorities competitively, it is important that life sciences brands are not held back by their respective regulatory obligations in each country or region. But this can happen when there is a missing link between corporate HQ and dispersed operations or affiliates doing frontline work in local markets, leading to a number of issues.

One is that group head office loses sight of the specific requirements in each territory as these evolve and change, as well as the ability to track how effectively these are being met. Another is that teams may be duplicating processes such as collating, updating and checking information at a global and at a local level. This can result in an uneconomical use of resources which local offices can ill afford. More worryingly, this could introduce inconsistencies and errors because there is ambiguous ownership and stewardship of the overall process.

In the meantime many local market operations, especially smaller affiliates, are struggling to manage their time between routine compliance work, including regulatory filings and pharmacovigilance (PV), and their core remit – of growing the local business, conducting scientific work with local patient groups, and other day-to-day responsibilities. As global regulatory and safety demands continue to grow more onerous and bureaucratic, this situation is becoming more acute.

So how are global pharmaceutical and biotech brands adapting?

Learning to let go.

Today we are seeing a sharp and steady rise in regulated requirements - around more detailed product reporting; greater transparency and traceability; and the proactive real-world monitoring and reporting required as part of ongoing patient safety/pharmacovigilance obligations. Yet there is nothing to say that this essential work has to be completed by local people on the ground.

The argument for centralising such activities is growing ever stronger, offering the scope for a clearer overview across all markets, and greater continuity in how the work is managed and done, if there is a single team taking overall responsibility. Centralised coordination ensures that processes don’t become disjointed, that important steps aren’t missed, and that HQ isn’t left out of the loop if something changes or goes awry in a particular market. It also makes it easier to introduce and replicate best practice, maximise resources, sharpen processes and accelerate delivery over time.

Rather than threaten people’s jobs, removing bureaucratic regulatory/safety reporting burdens from local teams will often come as a relief to them. As non-core activities are moved across to someone with a helicopter view of what needs to happen, local experts reclaim valuable time to devote to the skilled work they are qualified and paid to do.

Leaning on coordinated partners.

Outsourcing is still not used as extensively or consistently as it might be to bring closer alignment, coordination and consolidation of routine regulatory and pharmacovigilance work between the corporate core and satellite offices. Inertia, and the fear of immediate disruption, keep too many firms wedded to traditional ways of working - even if they know this is hurting them. That might be because it is costing more than it should; tying up valuable resources; and risking process repetition, data duplication and error - because of inconsistent oversight, quality control, and application of supporting technology.

There are signs, though, that accepted norms are beginning to shift. Increasingly, we are seeing companies look to cluster their use of external services - grouping together markets across a defined geographical region, and offloading repeatable activities to a single outsourced service provider or to a closely-linked network of partners.

As long as there is strong project management on the service provider’s side, workloads will become fully absorbed by the new team, requiring minimal client-side input. For an organisation with a fairly straightforward affiliate structure, the transition could be effected within as short a timeframe as 3-4 weeks.

Retaining valued staff.

When global organisations restructure their international regulatory/safety reporting, this is rarely from a perspective of wanting to cut staff. Rather, this is about refocusing skilled and expensive people’s time on more pressing commercial and scientific priorities.

Yet there is no reason why there couldn’t be provision for local team members to move into the service provider operations, or even vice versa. The point of the broader exercise really is about increasing process consistency, coordination and robustness - and providing scope for all levels and locations of the global business to benefit from corporate rigour, best practice and technology-enabled process transformation. All of which is about making it easier to do a great job well.

For instance, rather than each individual country team keep their own records of the latest local regulatory obligations and each set of updates, along with status information of where products are up to, the central service provider can keep a definitive central record of everything, as it applies to each client/market/particular set of circumstances. Which will make life easier for everyone.

Spreading the risk is important for business continuity reasons

An optimised approach to outsourcing will generally involve consolidating project management at a single point, rather than creating new work in coordinating and managing different suppliers. Yet it is important too to have backup delivery options.

A good way to achieve this balance is to bring in a global service provider capability with a range of different partners in each territory, to arrive at the optimum overall service. It is rare for a single outsourcing partner to have its own direct facilities in 140+ countries, but a well-coordinated network or ecosystem of quality-controlled service providers, with a strong project lead, will deliver the best of both worlds.

The important thing is that resources are scalable and available on demand, and combine deep subject expertise with expert local consultants, all brought together via central project control and coordination of communications.

Future-proofing should be an important part of the planning.

Finally, companies expand, merge, consolidate and change direction with regularity, which means their priorities and needs won’t always be constant. This applies to life sciences organisations whose strategic direction and market coverage plans may shift over time, and to service providers whose own commercial priorities may metamorphose with evolving market trends.

Rather than try to pre-empt all future possibilities, it is important to allow for evolution as part of service scoping, and focus as much on the cultural/relationship aspects of the new service contract as on the technical specifications of the work that needs to be done. Regular communication, too, will help identify how work or aspects of the engagement can be further honed over time.

A further consideration is the service provider’s technology roadmap. From use of document management systems, to real-time project management tools and at-a-glance dashboard performance/status displays, strategic software tools can transform global project coordination.

With due consideration to each of these five areas, companies stand a decent chance of bringing greater harmonisation to their global and local regulatory and safety activities, whatever lies ahead.

About the author

Anna Lukyanova

Anna Lukyanova is COO of Arriello, a provider of innovative, high-impact market access, regulatory Affairs & pharmacovigilance solutions and services for small to mid-sized biotech and speciality pharma firms.

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