Unlike your TV remote control, big business decisions don’t come with a rewind button. In the world of large clinical research organisations (CROs), many sponsors are finding protocol changes and timeline delays have become the norm rather than the exception. Emerging biotech and mid-sized pharmaceutical companies, in particular, are discovering that their decision-making process for selecting a CRO partner left out key criteria, leaving them wishing for a magical rewind button.
The phenomenon is pervasive, with sponsors defaulting to a CROs’ brand recognition over strategic fit. This autopilot approach to one of drug development’s most consequential decisions is costing sponsors millions in hidden expenses, delayed timelines, and missed opportunities. For capital-constrained sponsors operating in today’s unforgiving funding environment, these costs are coming under scrutiny with new assessment criteria being applied.
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Where good studies go wrong
Attention economics
The mathematics of CRO prioritisation are unforgiving. Large global CROs naturally allocate their best resources, most senior staff, fastest response times, and executive attention to their highest revenue accounts. This creates a predictable dynamic for emerging sponsors, one where their trials become ‘maintenance accounts’ rather than strategic ones.
The operational impact is palpable. Sponsors report longer response times for critical decisions, assignment of junior team members to key functional roles, and delayed escalation when problems arise. In more complex areas like oncology and rare disease trials, where scientific developments can shift strategy overnight, this attention deficit translates directly to competitive disadvantage.
Process rigidity versus scientific evolution
Global CROs optimise their operations for scale and predictability. These are qualities that serve larger pharma portfolios, but this standardisation creates friction when trials require the agility to adapt to emerging data or evolving regulatory guidance.
Protocol amendments illustrate this challenge starkly. Where specialised providers might implement critical changes in weeks, large CROs with multi-layered approval processes could extend timelines by months. For innovative programmes in complex therapeutic areas, where time-to-market directly impacts commercial potential, this rigidity represents a hidden tax on innovation.
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By GlobalDataWhen working with small patient populations, the problem compounds, as creative enrollment strategies and flexible operational approaches are essential to meeting enrollment targets. Clinical sites also face increased administrative burdens from complex CRO systems designed for global scale. This can cause sites to become less enthusiastic partners, potentially slowing enrollment or causing data quality to suffer.
The real economics of CRO selection, beyond the sticker price
Industry data reveals that staff turnover at the largest CROs averages around 20% annually, with some functional areas experiencing even higher rates. Each transition creates knowledge gaps that sponsors must fill through additional oversight, relationship rebuilding, and project re-education. The hidden cost of this turnover can be measured in sponsor time, delayed decisions, and lost institutional memory. This rarely appears in initial budget calculations.
Change orders represent another hidden expense. Rigid processes that struggle to accommodate mid-study pivots often generate costly amendments that could have been avoided with more flexible operational approaches. Sponsors report that seemingly minor protocol adjustments can trigger change orders worth hundreds of thousands of dollars when they must navigate complex approval hierarchies.
Emerging sponsor programmes represent a small fraction of major CROs’ total revenue. When contrasted with mid-sized and specialised CROs, where such studies represent core business, the difference in attention, resource allocation, and strategic importance becomes immediately apparent in day-to-day operations.
Four critical assessment criteria
Before selecting a partner, sponsors should evaluate CROs through metrics that predict operational success, including team stability, decision-making velocity, amendment agility, and risk partnership.
Request specific turnover data for functional leads on similar-sized studies. Organisations with rates below 10% annually demonstrate measurable execution advantages.
Ask for specific timelines on common protocol changes. These answers distinguish streamlined processes from bureaucratic hierarchies.
Evaluate whether potential partners proactively identify problems and if team members are authorised to raise issues to sponsors. Knowing the answers here can avoid delays in development.
Ensure that specialists with expertise in a trial’s specific indication, not just the therapeutic area, will support the study. Request concrete examples of similar studies and confirm that those team members will be on the sponsor’s study.
These four factors can help predict study success along with traditional criteria such as: more therapeutic area experience, global footprint, and contract value. Treat vendor selection like due diligence, stress-testing operational claims with specific scenarios and measurable commitments.
Strategic fit over ‘safety’ in size
Selecting a CRO for whom your study represents meaningful business creates operational advantages that extend beyond attention economics. When your trial is a critical piece of a partner’s core portfolio rather than one of thousands, the difference in urgency and continuity becomes clear. Bigger may not be better.
Therapeutic specialisation amplifies this effect. A right-sized CRO running a majority of its trials in your indication is more likely to anticipate site-level nuances, regulatory expectations, and data-collection pitfalls that generalists must navigate anew each time.
From autopilot to advantage
Industry experience makes it abundantly clear that the most successful sponsors don’t follow CRO selection conventions, but they interrogate them.
When sponsors take the time to evaluate team stability, amendment agility, and partner attention, they make decisions that compound in their favour. Those decisions often lead to faster resolutions, fewer budget surprises, and better outcomes for patients and programmes alike.
The safest option is the partner whose business model is aligned with yours, and for whom your trial is not just another line item, but a true priority.
