As clinical development grows more complex and globally interconnected, biotech companies are under increasing pressure to build CRO partnerships that deliver more than operational support. In this Biopharma Boardroom Q&A, Greg Plunkett discusses why strategic alignment, agility, and continuity are becoming critical to successful clinical execution. From balancing sponsor oversight with outsourced flexibility to navigating CRO consolidation and multi-partner collaboration, Plunkett shares how biotech companies can create stronger partnerships that reduce delivery risk and support long-term program success.

As clinical programs scale from early to later phases, how should biotech companies rethink the structure of their CRO partnerships to avoid inefficiencies or delays?

The CRO partnership can make or break a development program. When choosing the right CRO, biotech companies should look for partners who can grow and complement their internal team, not just simply based on a glossy leaflet or brand name. 

Applying a short term view, and selecting a CRO solely to support smaller, early-phase studies can mean that the trust, knowledge and alignment built early on are later lost when another partner needs to be brought up to speed. Equally, focusing too heavily on geographic footprint can reduce CRO selection to a question of scale, pushing biotechs toward larger providers rather than the partner best placed to support the program as it evolves.

Many CROs, including Accelagen, have developed infrastructure to support clinical programs across multiple jurisdictions, even where they may not specifically have a direct physical presence. By maintaining the relationship from the early phase, biotech companies can benefit from the experience built, creating efficiencies and gaining insight without being limited by geography.

Biotech companies should rethink CRO selection, with greater focus on true partnership and finding an extension of their team, rather than a service provider who micro-managed to deliver set tasks. The right CRO can guide the pathway based on its experience of the landscape, proactively identify key risks and navigate new opportunities.

What are the most critical factors sponsors often overlook when selecting and managing outsourced partners across clinical development?

Often, sponsors choose a clinical CRO based on size or a brand name, without fully considering whether they are the right partner. Bigger is not always better. For smaller biotech founders, partnering with a large multinational CRO in the hope that their program will be prioritised can be misguided. Instead, they risk becoming a small fish in a large pond, bound by processes, systems and execution strategies that can lead to cost creep and a loss of focus. Ultimately it can lead to disappointment, delays and unhappy investors/partners.

Companies should instead consider alignment in values and working principles, as well as the ability to adapt quickly as new information emerges. The CRO should act as an extension of the sponsor’s team, rather than replacing or duplicating it.

For emerging biotech companies in particular, how can they strike the right balance between maintaining control and leveraging the flexibility that outsourcing offers?

For emerging biotech companies, the right balance comes from maintaining clear and effective sponsor oversight of the program, while giving the CRO enough space to deliver effectively.

International regulations specify the need for sponsor oversight at all stages during the conduct of clinical trials. It's not about simply handing over responsibilities to someone else in the hope they do the best by you.  To fulfil this regulatory need, sponsors need to remain visibly involved in study conduct. Distance and time zones can make this feel more complex, which makes the choice of CRO partner especially important. The right CRO can help ensure regulatory expectations are met, Sponsor involvement is maintained, all without impacting study delivery.

This starts in the early discussions. Establishing clear communication pathways, documenting responsibilities and accountabilities and aligning on outcomes can help prevent misunderstandings later. Sponsor representatives do not need to be involved in every decision, but there should be agreed mechanisms for sharing updates, escalating issues and confirming critical decisions.

Company personnel should be active members of the study team, particularly when their input is needed. At the same time, they need to stay at a level of involvement that allows the CRO to deliver successfully within agreed processes and requirements.

For investigators and site personnel, having awareness of the company behind the study can also create stronger relationships and greater engagement.

With increasing consolidation and collaboration across the CRO landscape, how are partnership models evolving, and what does this mean for sponsors?

Recent changes in the CRO landscape, including company consolidation, have created opportunities for independent small to midsize CROs to establish a stronger presence. In a more consolidated market, these CROs can offer sponsors a more focused, efficient and responsive alternative to larger providers. 

For smaller biotech companies, consolidation can also create challenges. A program that begins with one CRO may later be managed within a larger, more complex organization, where priorities shift and the level of focus on that program may reduce.

This is where independent CROs with a collaborative model can offer a more dependable path forward. They provide the focus, agility and continuity sponsors need, while also giving access to broader expertise and more jurisdictions. This can help expand the potential patient pool without losing the close partnership smaller biotech companies rely on. 

Fragmentation across clinical, biometrics, and regulatory functions remains a challenge — what practical strategies can companies implement to better align these areas across multiple partners?

Choosing to use different vendors to support a clinical study is often seen as a way to allow specialists to deliver specific parts of the program. However, it also means the sponsor must maintain consistency across organizations with different systems, processes and priorities. This can create inefficiencies and unnecessary complexity, potentially leading to delays.

Where multiple providers are involved, there must be a central point of oversight. This often sits with the clinical project manager, who acts like a conductor of the clinical trial orchestra. This role is most effective when the project manager has full visibility of how each party interacts, communicates and delivers.

An engaged and empowered clinical project manager is therefore crucial to achieving the right outcome. Appointing this role from the start, either within the clinical CRO or the sponsor company, can help minimize barriers between providers and support better alignment.

With multiple providers being involved in program delivery, strong oversight is essential. However, sponsors can reduce some of this complexity by keeping these functions within a single organisation. Established processes between teams, such as data management and clinical monitoring, can create a more integrated way of working, support smoother collaboration and reduce the need for sponsor intervention at every handoff. 

From your experience, what defines a truly strategic, long-term CRO partnership, and how can it help reduce delivery risk and improve program continuity?

Being a strategic partner means moving beyond a transactional model and taking shared ownership of the journey. It means being present when things are going well and when challenges arise, with a genuine commitment to the outcome.

It also means understanding the client’s values and goals, then staying aligned with them throughout development. For Accelagen, this is about adding value to both the client and their development assets, whether by improving study design, finding better ways to execute or helping shape stronger outcomes.