Adapting at the pace of development: Why operating model flexibility is key to success

As anyone in biopharma or biotech can attest, the speed and complexity of clinical development are only escalating. Science progresses quickly. Research expands to include new indications and geographies and grows increasingly nuanced as we pursue highly tailored therapies. New technologies improve efficiency but also test the limits of our governance structures. Pathways to regulatory approval shift and post-approval commitments intensify. 

To capitalize on every opportunity, developers must be able to quickly accelerate, expand, or pause programs and reprioritize resources to match emerging needs. The challenge? Portfolios are becoming far more dynamic than the operating models behind them. That impedes agility, which impedes innovation. 

In an earlier era, when development demands were more predictable, sponsors could build up and rely on internal capacity — an approach that creates stability but also rigidity. In today’s environment, however, the ability to adapt is essential. A sponsor’s operating model must evolve as quickly as the science it supports.  

Capability over capacity  

The organizations that outperform will be the ones most committed to agility. Success will be determined not by the size of your internal team but by your access to capabilities, expertise, and technological innovation — at speed and without organizational complexity or fragmentation. 

Functional Service Provider (FSP) outsourcing can be a fundamental part of an agile operating model. FSP arrangements have always been an avenue for flexible staffing, but as sponsors face new opportunities and new pressures, the approach is moving beyond headcount-based strategies. At Parexel, we’ve introduced FSP Integrated Solutions: an enterprise-capability partnership that offers unified service delivery focused on outcomes, and a single point of accountability. 

Through conversations and collaborations with customers, I’ve seen that sponsors need more than just individual functional support from their CRO. We believe the future is connected capabilities — a coordinated, cross-functional outsourcing model that provides expertise, technology, and talent. Thanks to its streamlined nature, this model also creates clearer accountability based on outcomes, not hours worked. The connected operating model lets us work faster, with fewer handoffs and greater insight. 

A bespoke approach to outsourcing 

In helping customers design fit-for-purpose outsourcing partnerships, we begin by assessing the ideal ownership mix. Which capabilities should a sponsor manage internally? Which should be automated? Which should be entrusted to the drug development partner? 

In recent qualitative research commissioned by Parexel with senior clinical development and operational leaders, participants described actively reassessing which capabilities to retain internally and which to access through external partners. The considerations included where strategic expertise and decision-making should sit and where demand fluctuates across the portfolio. 

For a growing sponsor running several studies or expanding into new regions, that might mean retaining portfolio priorities, clinical strategy, and governance internally while accessing connected capabilities across study start-up, monitoring, data management, and statistical programming as requirements change. For an organization managing a broader portfolio across the product lifecycle, the mix may look different again: maintaining strategic regulatory and safety oversight internally while using a partner for scalable regulatory operations and pharmacovigilance delivery, alongside other capabilities needed as products move from development through approval and post-approval. 

There is no standard formula. Our goal is to help customers find the balance that provides the capabilities their portfolio needs while maintaining appropriate control, agility, and accountability. 

Beyond determining the ownership mix, sponsors can build greater flexibility into their operating models by: 

Planning for access to specific capabilities rather than specific headcounts. This might require a shift in your organizational culture as leaders learn about the value of the enterprise-capability FSP approach. 

Supporting human experts through AI-enabled tools, workflows, and automation. When implemented purposefully, AI can reduce manual activity, improve operational visibility, and accelerate execution. For example, ParexelAI™ can deliver a 50% reduction in the time required for site selection and a 30% reduction in the time required to prepare clinical study reports. 

Adopting governance structures concerned with outcomes rather than activities. Instead of dictating strict guidelines or specific actions, this style of governance sets clear expectations for results, then empowers individuals within the organization to decide how they will achieve them. 

As you evaluate your approach to outsourcing — and the partners you collaborate with — the team at Parexel is always available for a conversation. From clinical operations and biometrics to regulatory, safety, medical writing, and therapeutic expertise, we can improve your productivity without increasing organizational complexity. 

For 25 years, we’ve developed and delivered FSP models that have a 90% retention rate. And with more than 8,000 FSP professionals supporting engagements across 46 countries, we have both the experience and expertise to deliver the outcomes that matter to your organization and to the patients waiting for your next innovation.

Return to Insights Center