Fit Over Formula: Choosing the Right CRO Model to De-Risk Your Clinical Trials
By Michael A. Bishop1
What’s the right CRO model for your next clinical trial? The answer isn’t found in industry trends or legacy contracts, but in how well the model aligns with your development goals, internal resources, and therapeutic strategy. In this article, Mike Bishop of Emerald Clinical Trials breaks down why fit matters more than formula, and how choosing the right model early can be the most effective way to de-risk your trial.
Over the past two decades, clinical research has weathered financial shocks, global pandemics, regulatory shifts, and wave after wave of outsourcing reinvention. But amid all this change, one challenge remains constant: how to design partnerships that de-risk trials and accelerate outcomes. Sponsors need partners who can adapt to their goals, deliver with precision, and scale strategically, all without introducing unnecessary complexity.
There is no universal outsourcing playbook. No engagement model, whether full-service, functional service provider (FSP), or hybrid, delivers results by default. The success of any model depends entirely on how well it aligns with a sponsor’s development strategy, internal capabilities, and commercial objectives.
Yet in an industry prone to rinse-and-repeat thinking, too many sponsors rely on legacy outsourcing models that no longer serve them. That misalignment can quietly inject friction, waste, and risk into even the most promising programs.
The smarter approach is simple in theory, harder in practice: select the model that matches the real demands of your trial rather than the one that’s most familiar.
Development Goals Should Define the Model
The full service CRO model is especially valuable for early-stage biotech companies, which often face intense pressure to move quickly in a highly competitive funding and drug development environment.2 Building the infrastructure required to run successful early-phase trials, such as establishing site relationships, negotiating master service agreements with a wide range of specialized vendors, and cultivating engagement with global investigators, takes years.3 These are resources and networks that a young biotech simply doesn’t have time to develop from scratch.
A seasoned CRO brings this infrastructure to the table from day one. They offer ready-to-go access to high-performing sites, pre-negotiated vendor relationships, and established trust with key investigators, especially in competitive therapeutic areas like oncology. This means trials can be activated faster, enrollment can begin sooner, and timelines can be compressed without sacrificing quality or compliance.
For an emerging biotech, partnering with a CRO isn’t just about outsourcing operational work but about gaining a strategic partner who can provide scale, experience, and global reach. In today’s market, where speed to data is critical and funding milestones are tightly tied to progress, the CRO model enables biotech companies to stay focused on innovation while ensuring their trials are powered by the infrastructure needed to succeed.
On the other hand, more mature companies may have built internal teams to handle strategic planning, scientific leadership, or site engagement for their core therapeutic areas. These sponsors may prefer to maintain control of those areas and bring in CRO partners only for specific executional functions. In these cases, FSP or hybrid models offer greater precision and cost control. However, for non-core therapeutic areas or geographic regions, the full-service model would still apply.
The Myth of the “Best” Model
It is tempting to think of one model as inherently superior. The full-service model promises simplicity and speed. The FSP model suggests control and efficiency. Hybrid models claim to offer the best of both worlds. But these are only frameworks. Execution depends on the quality of the partner, the design of the collaboration, and the match between strategy and structure.
What matters most is not the shape of the model, but how well it reflects the needs of the study and the sponsor’s broader commercial strategy. That means looking beyond standard scopes of work and thinking critically about what the trial needs to accomplish.
Is the trial meant to establish early efficacy in a rare population? Is the goal to build a robust dataset for out-licensing? Is this a pivotal trial for regulatory submission in multiple countries? These questions are not trivial. And they should define the operating structure from day one.
Therapeutic Specialization Adds Strategic Value
Model fit is important, but domain expertise can elevate even the best-designed partnership. In many therapeutic areas, especially those involving complex diseases or hard-to-reach populations, the CRO’s clinical and operational knowledge becomes a critical differentiator.
Sponsors increasingly recognize that selecting a CRO with therapeutic depth, not just general capabilities, can be better at de-risking trial design, recruitment, and interpretation.4 For example, a consultancy program focused on a specific disease area could provide sponsors with invaluable support before a single patient is enrolled, offering insight into protocol feasibility, endpoint sensitivity, investigator engagement, and regulatory considerations. This kind of early-stage collaboration helps sponsors build trials that are both scientifically sound and commercially relevant.
Therapeutic specialization by the CRO partner is particularly valuable for sponsors who lack in-house expertise in a given indication. Research sites and investigators prefer working with a familiar CRO that understands their workflow and generates a consistent volume of work for them in their therapeutic specialization.5 It also benefits those who are planning to license their asset post-Phase 2 and need to demonstrate not just efficacy, but a credible future development path.
De-Risking Through Structural Alignment
Sponsors typically think of de-risking in terms of trial operations: hitting enrollment targets, avoiding protocol amendments, managing site performance. But the deepest form of de-risking starts long before site activation. It starts with choosing a CRO model that matches the sponsor’s capabilities and anticipates the program’s likely inflection points.
When a CRO is slotted into a role they weren’t built to handle, inefficiencies emerge. Timelines slip, costs balloon, and trust erodes. Conversely, when a CRO’s responsibilities are clear, expertise is relevant, and communication is built into the process, trial execution becomes more predictable.
This kind of structural alignment also makes it easier to adapt when conditions change. If a trial expands into new geographies, shifts in design, or accelerates its recruitment goals, a well-chosen partner can flex accordingly. That responsiveness is often the difference between staying on track and falling behind.
Regional Execution Is Not a Plug-In
Another dimension of de-risking involves geography. Sponsors are increasingly turning to Asia-Pacific and other underutilized regions to access untapped patient populations, faster startup timelines, and alternative regulatory pathways.6 But success in these regions requires understanding the local environment, solid relationships with investigators, and know-how to navigate regulatory nuances.
Rather than assigning these regions to subcontractors or adding them late in the planning process, sponsors should incorporate regional strategy into their CRO model from the outset. This enables better harmonization across global trials and reduces the risk of bottlenecks or misaligned timelines.
In some cases, splitting execution by region (e.g. assigning North America and Europe to one CRO, and Asia-Pacific to another) can provide the best balance of global oversight and local execution. The key is ensuring each partner has a defined role, equal footing, and shared accountability.
Final Thought: Model Fit is a Strategic Choice
Too often, CRO engagement is seen as a one-off transaction. A sponsor defines the protocol, issues the RFP, selects a vendor, and executes the trial. But this linear approach misses an opportunity to create a strategic partnership. After all, clinical trials are complex, high-stakes endeavors and no sponsor enters them hoping for average results.
Sponsors should approach CRO engagement the same way they approach trial design: at the planning stage, with strategic intent, informed assumptions, and a clear understanding of the endgame. That means asking not just who can do the work, but who can help achieve the outcome. It means looking beyond standard offerings and selecting a structure that reflects where the sponsor is today, and where they want to go.
There is no best model. But there is always a right fit. And finding it is one of the most strategic choices a sponsor can make.
- Michael Bishop is Chief Commercial Officer at Emerald Clinical Trials. He has over 30 years of business development and life sciences experience with companies including Cardinal Health, PPD, ICON, and, most recently, Ergomed/PrimeVigilance. Over the last 16+ years, Michael has led various CRO commercial teams including those in business development and global strategic accounts driving business strategy for large pharma and biotech companies. ↩︎
- Capra, Emily, Christian Fougner, Olivier Leclerc, Ahti Mäkitie, Anthony Suberski, and Michelle Suhendra. “What Early‑Stage Investing Reveals about Biotech Innovation.” McKinsey & Company, December 12, 2023. (mckinsey.com) ↩︎
- “The Drug Development Process. Step 3: Clinical Research”. US Food and Drug Administration. 4 January 2018. ↩︎
- Gunn, Mary. “Clinical Trials as a Competitive Edge: Strategic Considerations.” Applied Clinical Trials 34, no. 3 (June 16, 2025). ↩︎
- Tinoco, Daniella, and Christine Moore. “The Value of Clinical Trial Liaisons in the Drug Development Lifecycle.” Applied Clinical Trials 34, no. 2 (February 4, 2025). ↩︎
- Incorvaia, Darren. “CRO and Clinical Trial Markets Set for Growth by 2030, Especially in Asia‑Pacific Region: Reports.” Fierce Biotech, December 4, 2024. ↩︎
