Clinical trials are becoming more complex, global, and scientifically sophisticated. At the same time, many of the operational assumptions guiding the industry were established decades ago.

This series examines some of those assumptions directly, not focusing on trends or positioning, but on practical decisions clinical development teams face when designing and delivering pivotal trials.

The goal is simple: To ask whether common industry practices truly support reliable clinical execution.

Introduction

One assumption has become almost automatic in clinical trial planning: A CRO with its own central laboratory offers a more efficient and reliable execution model. Integration promises fewer handovers, simpler governance, and faster study set-up.

However, as protocols become more specialized, and biomarker strategies play a greater role in development decisions, sponsors are asking a more practical question: Does owning a central lab improve execution quality, or does it narrow the ability to select the laboratory expertise a study actually requires?

The answer depends less on structure, and more on context.

The purpose of central laboratories in modern clinical trials

Central labs play an important role in clinical development. They can standardize testing methodologies, reduce variability across sites, and enable consistent data collection across regions.

Within integrated CRO models, central labs can offer operational advantages:

  • Simplified contracting and governance, reducing the number of vendor relationships sponsors must manage
  • Unified data infrastructure, enabling faster transmission of laboratory results into clinical databases
  • Standardized workflows, which support consistency across large, multi-country trials
  • Close alignment between laboratory data and clinical operations

In large, standardized programs, these benefits can translate into faster study setup and streamlined execution.

However, integration is not universally advantageous. As trial designs evolve and protocol complexity continues to increase, sponsors are increasingly evaluating the trade-offs between operational consolidation and scientific flexibility.

Where integration meets complexity

The limitations of integrated laboratory models become apparent when study protocols require services that are not available within the centralized environment. This may occur, for example, when specific biomarkers are not offered in-house or when region-specific regulatory requirements cannot be met without local validation. In addition, specialized testing – such as microbiology, genomic profiling, or pharmacodynamic assessments – often relies on niche expertise that sits outside standardized laboratory settings. While integrated laboratory models may appear streamlined during the study planning phase, evolving requirements during study execution can introduce constraints that cannot be addressed internally. In these situations, access to an extended network of pre-approved subcontractors becomes critical for developing a feasible and effective laboratory strategy.

This highlights the importance of strong strategic partnerships with specialized laboratories. In practice, such partnerships are often more valuable than a fully integrated model alone, as they enable the flexibility needed to adapt and maintain an effective laboratory strategy over the course of a study – or program.

The trade-offs sponsors should evaluate

Sponsors are increasingly assessing lab strategy across several critical dimensions:

Clinical trials rarely follow a perfectly predictable path. Protocol amendments, evolving biomarker strategies, and regulatory feedback can all require adjustments to laboratory testing strategies.

Integrated models typically rely on predefined internal workflows, which can streamline initial setup but may reduce flexibility when study requirements change.

An independent model allows sponsors and CRO teams to select or change lab partners when study needs shift, particularly when new testing capabilities become necessary if study needs shift.

Laboratory strategy is often shaped earlier than sponsors expect – sometimes before the protocol is fully stabilized.

In integrated models, where laboratory services sit within the same organizational structure as clinical operations, this proximity can influence feasibility assumptions, sampling strategies, endpoint handling, and assay selection. This is not a matter of individual preference, but a structural effect: When an internal laboratory is available, it naturally becomes the default reference point during study design.

However, in trials involving evolving biomarkers, specialized diagnostics, microbiology endpoints or region-specific regulatory requirements, early alignment around a predefined laboratory environment can make later adjustments more complex.

Maintaining vendor neutrality allows clinical teams to evaluate laboratory options against the scientific and operational needs of the protocol itself – supporting decisions that prioritize endpoint integrity.

Clinical development is increasingly shaped by precision medicine. Many trials now rely on advanced biomarker endpoints, genomic testing, or complex pharmacodynamic analyses.

Standardized workflows used in integrated models can support consistency and scalability, but they may not always align with the unique scientific requirements of each study.

Independent approaches allow sponsors to assemble a network of best-fit laboratory partners that match the scientific and operational requirements of each study, rather than adapting the protocol to fit existing capabilities.

Lab performance is not uniform across assay types, therapeutic areas, and patient populations. A laboratory that performs exceptionally well in routine chemistry testing may not have the same expertise in advanced molecular diagnostics or rare disease biomarkers.

In pivotal trials, where clinical and regulatory decisions depend heavily on laboratory data, selecting laboratory partners with demonstrated expertise in specific testing domains becomes a form of risk management strategy.

A different operational model

Some CROs, including PSI, have chosen not to operate central laboratories as part of their service model. This is not a limitation, but a deliberate operational choice.

In practice, this changes how laboratory strategies are developed and executed. Our dedicated Laboratory Support Services Team is able to:

  • Consider multiple laboratory providers in parallel during study-specific vendor selection process
  • Select partners based on specific assay expertise and study requirements
  • Adapt laboratory strategies as protocols evolve
  • Combine global and regional laboratory networks to align with regulatory and logistical needs
  • Access niche specialty laboratory services that CROs with integrated labs may not be able to access

Rather than embedding laboratory services within a fixed internal structure, this model allows each study to be supported by a laboratory ecosystem tailored to its scientific and operational demands. In complex global studies requiring therapeutic specialization, adaptive approaches or evolving biomarker strategies, this flexibility supports a core objective: Ensuring that operational decisions serve the science of the study and the needs of the sponsor.

Choosing the right model for your study

There is no universally correct laboratory strategy. The optimal strategy depends on the specific requirements of each study.

By navigating dynamic studies and evolving vendor landscapes, CRO teams build the resilience and agility to identify the most effective solutions. The focus on assembling the right external expertise for the task allows them to adapt to complexity, rather than be constrained by it.

For large, pivotal programs where outcomes depend on specialized, high-precision testing, the ability to select best-fit laboratory expertise can reduce operational risk, and improve data quality. Therefore, rather than assume that CROs that offer selected integrated laboratory services offer clear benefits, sponsor teams should be focused on the breadth and depth of services CROs can offer whether internally or externally via their extended vendor networks.

Execution matters more than ownership.

Integration can simplify operations; it does not automatically optimize outcomes.

The future of clinical trial operations will not be defined by how many capabilities a CRO owns internally, but rather by how effectively the right expertise is assembled and coordinated for each individual study.

Evaluating CRO operating models?

If you are evaluating CRO operating models or vendor strategies for an upcoming program, our clinical teams are available to discuss your study.

Speak with our team