Key takeaways
AI and tech expertise are becoming core clin ops requirements: Success increasingly depends on integrating AI, predictive analytics, and advanced data tools—requiring teams with specialized digital and data skillsets.
Blended FSP/FSO models provide needed flexibility: Hybrid outsourcing approaches help sponsors adapt quickly by combining strategic control with scalable, tech-enabled support.
Innovation is essential, not optional: CROs and sponsors that fail to evolve operational models risk obsolescence in the face of rising complexity, competition, and patient expectations.
At a time when artificial intelligence (AI) is redefining industries at an unprecedented pace, the pharmaceutical sector stands on the brink of a progressive transformation. AI is not just a tool but a catalyst that promises to accelerate drug development timelines in ways we’ve never seen before.
However, the true potential of AI can only be realized if we simultaneously revolutionize our operational processes. As we face this pivotal moment, the future success of our industry hinges on our ability to swiftly integrate these novel technologies, ensuring we are prepared to meet the challenges and opportunities of tomorrow with agility and flexibility.
Technological innovation is revolutionizing clinical trials
Technology is fundamentally altering the landscape of clinical research across the pharmaceutical industry. The wealth of untapped potential and innovations ready to be implemented is vast, ranging from patient recruitment and retention to data analysis and trial design optimization.
Where appropriate, technology is increasingly being applied, such as in predictive analytics for site selection, real-time monitoring of patient data, and automated protocol design. This shift is driving efficiency, which is being internalized by pharmaceutical companies and contract research organizations (CROs) alike. In turn, the industry is moving toward a more integrated and holistic approach, where technological solutions cross functions and businesses break down traditional silos.
There is also a growing recognition of the need for centralized solutions that can eliminate these silos, enabling seamless communication and data sharing across various stages of clinical trials. As a result, outsourcing strategies are evolving to prioritize partnerships with CROs and technology providers that can offer comprehensive solutions spanning the entire clinical trial process, from protocol development to regulatory submission.
With these technological innovations, the need for talent that understands and can implement these technologies is increasingly important. As an industry, we are facing a new challenge of finding and recruiting the specialized expertise that this work demands such as biostatisticians, data managers, and sophisticated project management capabilities who can coordinate these intricate studies effectively. The future workforce should blend new skills such as proficiency in AI with a deeper understanding of therapeutic areas while possessing a broader understanding of the entire development process. This includes fluency in data management, analysis, and visualization tools, as well as comfort navigating complex datasets, understanding data structures, and applying statistical principles.
Choosing an outsourcing approach that allows for flexibility
One of the keys to agile clinical research that can quickly adapt to changing market demands and the pharmaceutical company’s needs is creating an outsourcing strategy that enables the operating model to change as needed. Outsourcing approaches can be designed to offer flexibility and options regarding pricing, oversight, shared risk, and governance.
Both full-service outsourcing (FSO) and functional service provider (FSP) models have strengths, but also limitations. An FSO model allows pharmaceutical companies to completely outsource responsibilities to a CRO partner including accountability for overall study delivery, task performance, and resource management. This can be useful for organizations when there is a limited pipeline, or they are working with a therapeutic area with high variance in site demand.
On the other hand, FSP models are best suited for flexibility. Sponsors can rely on outsourcing partners to augment their existing teams or to fully manage certain functions, such as data management, biostatistics or site monioring, throughout their portfolio of studies. This can be useful for companies to quickly leverage innovations without requiring the resources to recruit, train, and retain an entirely new area of expertise. Through an FSP model, sponsors can have access to resources where and when they need them with additional therapeutic and indication-specific expertise to augment their staff. This support can be scaled up or down more easily than with an FSO model.
In the middle where these two models meet, a more bespoke, customized approach exists that enables CROs to leverage cutting-edge technologies that go beyond traditional boundaries while still maintaining oversight as needed. By blending FSO and FSP models, CROs can create a flexible approach that both optimizes resource allocation and efficiency to meet their organization’s needs and meets the dynamic demands of the industry.
With a broader, more strategic view into an organization’s specific challenges, these outsourcing approaches can be designed to offer flexible options. This adaptability enables CROs to seize the best opportunities and resources as they emerge, ensuring strategies remain responsive and efficient in a rapidly changing landscape. And with this blended approach, strategy is driven by expertise and best practices, not by the model itself.
Continuous innovation is paramount
It’s important to also take a moment to consider the consequences of not evolving our approaches. Thinking back to those software companies that had to change their ways of working, I’m sure it is easy to recall a few that failed to innovate and thus fell by the wayside, such as BlackBerry, Kodak, and Polaroid.
Some failed to adapt to technological changes or market shifts, others were overconfident in their brand and market position, becoming misaligned with consumer trends and needs. This is similar to what we are seeing today with changing patient expectations, regulatory requirements, and new emerging therapeutic areas—and those who are slow to respond to competitors advances or fail to anticipate shifts in trial participation will be left behind.
Ultimately, innovation is not optional, it is essential for survival and growth in our evolving industry. Even the most well-established companies can fail if they don't continuously innovate, adapt to market changes, and stay aligned with evolving needs and preferences. And if CROs fail to embrace more innovative, flexible approaches, they too risk becoming obsolete in an increasingly dynamic and competitive landscape.
Today, the pharmaceutical industry stands at a critical juncture, with a wealth of untapped potential and innovations ready to be implemented. The question is: who will take advantage and adapt their outsourcing strategies to these more fluid, customizable approaches that adapt to real-time needs and industry advances? By leveraging innovative technologies and approaches, CROs have an opportunity to create a new paradigm of intelligent, adaptive outsourcing that evolves through this era of innovation.
Michelle Verhaeghe, VP of functional service providers (FSP) clinical operations, Parexel
