SCOPE 2025: Outsourcing in the Era of Agile Biopharma Innovation

The recent SCOPE conference, which brought together over 4,000 industry professionals, offered a panoramic view of the rapidly evolving landscape of clinical drug development. It was inspiring to be a part of this global community of innovators, as we continue to work together to shape the future of drug development and drive progress forward.

Today, we stand at a critical juncture. The biopharma industry is undergoing rapid transformation, driven by technological advancements, market dynamics, and global events. From harnessing the potential of AI to strengthening site relationships and navigating the ever-evolving regulatory and reimbursement landscape, the conference challenged us to think about the role we play in pushing past boundaries to optimize trial design, enhance patient-guided development, and leverage technology effectively. The conference instilled a sense of urgency to embrace change and adopt the emerging solutions at our doorstep.

As a career life sciences professional, I was particularly struck by the innovative approaches to outsourcing that are reshaping our industry in response to the unique needs of biotech and larger biopharma companies. Here are a few insights and trends that emerged:

Agile outsourcing: A new paradigm

AI is rapidly permeating every area of the product life cycle, particularly within clinical development. Featuring prominently in multiple session tracks, conference presenters highlighted cutting edge AI applications that promise to revolutionize trial design, drug safety and pharmacovigilance, enhance patient experiences and accelerate drug development timelines through automation, content authoring, data analysis and predictive analytics, among other innovations. 

Given AI and technological advancements, we have a wealth of untapped potential and innovations ready to be implemented. The question is: how do we adapt our outsourcing strategies to leverage these advancements and the growing complexity and scale of clinical studies?

Michelle Verhaeghe, Vice President, FSP Clinical Operations at Parexel, posed this question during her presentation on "Futureproofing your outsourcing model."  Drawing parallels with the automotive and IT industries, she emphasized the need for the biopharma industry to move beyond traditional stepwise development and embrace agility. After decades of incremental progress in clinical trial design and execution, the necessary technological, regulatory, and talent infrastructure is now in place to enable accelerated innovation adoption. This is similar to the transformative advancements within the automotive industry during the Industrial Revolution and the more recent growth in the information technology sector.

With the need for operational agility, a new paradigm in outsourcing that blends the strengths of Full Service Outsourcing (FSO) and Functional Service Provider (FSP) models is emerging, creating a more customized approach. Unlike previous shifts between fully outsourced and FSP models, the current transformation represents a rebalancing to achieve a more flexible outsourcing strategy, enabling sponsors to tap into specialized expertise while maintaining control and oversight of clinical operations. This approach aims to overcome the limitations of one-size-fits-all solutions and address the increasing pace of innovation, unpredictable external factors, and growing trial complexity.

The key is to build an outsourcing strategy that allows for adaptation of the operating model as needed. This requires taking a holistic view — one that considers all functions within the sponsor’s organization, whether a biotech or larger biopharma company — and the interconnected nature of the industry. 

Strategic CRO-sponsor collaborations 

Holger Liebig, Executive Director, Partnership Center of Excellence at Parexel, and Melissa Bencivengo, Director, Alliance and Partnership Management at Bayer, showcased the power of true collaboration, further expanding on the critical elements of successful governance in strategic CRO-sponsor collaborations. 

As co-presenters, they shared a case study on the Bayer-Parexel partnership, emphasizing the need for cultural alignment, communication frameworks that break down siloes and a shared commitment to continuous improvement. The takeaway? Successful partnerships are about co-creating value and a balanced, agile, framework that prioritizes team dynamics, risk management and continuous improvement initiatives, including performance metrics and the ability to link KPIs to value creation.

Looking to the Future

SCOPE 2025 underscored that the future of outsourcing in clinical research lies in flexibility, customization, and true partnership. As we navigate this transformative period, one thing is for certain – the breakthroughs of tomorrow will be born from the collaborations we forge today.

The message is clear: our industry is evolving rapidly, and success lies in our ability to adapt quickly. We must move beyond one-size-fits-all solutions and embrace customized, agile approaches that meet each client’s unique needs, aligning with them throughout their entire drug development journey.

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