What role do contract research organisations have to play in pre-clinical trials?
UK-based Contract Research Organisations (CROs) are increasingly stepping onto the global stage, positioning themselves as vital partners in the pharmaceutical and biotech ecosystem. With a reputation for scientific excellence, regulatory expertise, and innovation, UK CROs are no longer just supporting domestic projects, they are actively seeking international collaborations to fuel growth and strengthen their global footprint.
As big pharma and emerging biotechs look for trusted partners to accelerate drug discovery and development, UK CROs are leveraging their agility, technical depth, and world-class research capabilities to capture new opportunities worldwide.
Smaller, specialised UK based CROs are known for providing a more flexible service offering, coupled with strong compliance and data integrity, making them a reliable and trusted partner. In line with this, Cellomatics is experiencing an upsurge in engagement particularly in the US and European markets. Indeed, the US market now accounts for approximately 25% of Cellomatics’ revenue. So, how are CROs like Cellomatics helping to accelerate preclinical assay timelines without compromising quality, and what impact does this have on big pharma’s ability to meet critical development milestones?
We met with Cellomatics’ CEO, Dr Shailendra Singh, European BD Consultant, Dr Pier George Amendola and Finance Director, Stuart Gibson, to hear their insights and get answers to some probing questions.
In what ways can CROs bring specialised assay technologies, expertise or techniques that pharma companies might lack in-house, and how does this influence decision-making in early development?
Pharma pipelines are increasingly fed by external innovation, with more than half of new drug revenues now originating from licensing or M&A (McKinsey, 2025; Schuhmacher et al., Drug Discovery Today, 2025). As a result, companies are frequently onboarding projects from new therapeutic areas or technologies, often through due diligence on academic assets or early-stage biotech companies where internal development expertise may be limited.
Specialised CROs provide validated assay platforms, extensive technical expertise, and independent data generation, offering a more time- and cost-effective solution than developing equivalent capabilities in-house. Externally generated data also plays a critical role in validating key findings, while reducing bias and freeing internal teams to focus on strategy and trial design. This enables faster decision-making, consistent application of quality standards, and robust data packages for both governance milestones and regulators.
Do you believe that CROs have a role to play in improving assay reproducibility and standardisation across multiple sites, and how would/does this strengthen regulatory submissions for pharma?
Yes. Developing and validating assays in-house is often resource-heavy and time-consuming. This essentially forms the core business of the specialised CROs who invest in standardisation, controls and validation to ensure robust reproducibility.
The outcome is extremely reliable data packages that can be easily defended during the regulatory review process. Studies run with defined positive and negative controls, and under structured quality frameworks, offer sponsors confidence that the results can transition seamlessly to later regulated studies (Lavelle & Brunner, Pharmaceutical Technology / PPD, 2022).
How can CRO partnerships reduce the cost and resource burden of scaling up preclinical assays, while allowing pharma to focus on strategic priorities such as clinical trial design and portfolio management?
Drug research is increasingly complex and competitive. Building internal assay capacity requires major investment in infrastructure, equipment and staff. CRO partnerships convert these fixed costs into a flexible alternative. Working with external experts provides access to specialised knowledge, advanced equipment and scalable support. Sponsors gain immediate access to skilled teams and established platforms, while internal staff can focus on strategic priorities such as trial design, regulatory strategy and portfolio governance.
For instance, Cellomatics enables rapid scale-up of in-vitro screening and biomarker work, reducing costs and risks while delivering high-quality decision-ready data.
In what ways can CROs support translational research by bridging preclinical assay data with clinical trial endpoints, thereby reducing the risk of failure in later stages of drug development?
Many clinical trials fail due to poor translatability between preclinical models and humans. CROs can help bridge this gap by offering more predictive models, such as 3D cultures, immune co-cultures, organoids or ex-vivo assays with human cells. These systems improve the biological relevance of early data and help identify biomarkers that can be carried into the clinical work, reducing attrition and supporting better endpoint selection.
How can CROs act not just as service providers but as strategic collaborators, bringing innovation in assay design, data analytics, or biomarker discovery, that directly shapes pharma’s R&D pipeline success?
The most impactful CRO partnerships go well beyond service execution. Smaller, specialist CROs can co-develop assays and protocols closely with sponsors, bringing fresh innovation in biomarker discovery and data interpretation without the bureaucracy often associated with larger providers. Their size allows them to be more agile, flexible, and responsive, adapting protocols quickly, tailoring models to specific projects, and offering direct scientific engagement with senior experts.
In this role, the CRO acts as a specialised external extension of the R&D team: helping companies differentiate assets, generate stronger evidence packages, and move faster in highly competitive areas. For pharma clients, this goes beyond outsourcing, partners like this actively shape the early R&D trajectory.
What changes have you noticed within your own markets (Europe/USA) in how pharma companies are approaching/engaging with CROs?
There is a clear trend toward reducing internal early-stage R&D and activating external partners instead. Open innovation, both outside-in and inside-out, has become the dominant model, allowing companies to keep therapeutic pipelines agile without the burden of large, fixed infrastructures (BiopharmaTrend, 2023).
The rising complexity of new modalities also makes it unrealistic for pharma to retain all expertise in-house. As a result, demand is growing for specialist CROs that can provide high-quality, reproducible data and translational support.
Where, and how, do you feel CROs such as Cellomatics can have the biggest impact?
The greatest value lies in validating external innovation and providing independent, decision-ready data. When companies license or acquire early assets, CROs can confirm findings, develop bespoke assays, and identify biomarkers that inform clinical strategy.
Access to healthy donor samples and disease-specific material further enhances the translational value of these studies, ensuring early results are biologically relevant and credible for regulators.
How do you see the future in terms of relationships – particularly within your own geographical markets – evolving between CROs and big pharma?
We believe the direction is toward long-term, strategic collaborations rather than one-off projects. Multi-year frameworks combine flexible capacity with co-development and innovation, with a close working relationship built on mutual understanding and trust, allowing pharma to control costs while maintaining agility.
In Europe especially, companies are streamlining internal R&D space and increasing relying on external partners for discovery and translational work (European Parliament study, 2021). CROs that combine strong quality systems with specialised expertise will increasingly act as trusted collaborators shaping early R&D strategy in drug development.
