June 4, 2025
Bringing a new therapy to market can be a monumental task. From early discovery through to regulatory approval, the process requires deep expertise, operational efficiency, and strict compliance with evolving standards. To meet these demands, many pharmaceutical and biotech companies rely on outsourcing to a contract research organization (CRO).
Understanding the role of CROs in drug development, the benefits they can provide, and how to select a partner that works for your specific needs is key to streamlining therapeutic development.
So what is a CRO, and how can the right partner help accelerate bringing a therapy to market?
A CRO is a company that provides outsourced drug development services for pharmaceutical and biotech companies. CROs typically work with clinical trial sponsors to design, manage, and execute various aspects of the drug development process that sponsors may be unable to complete in-house. Bringing specialized expertise and capabilities, CRO services extend across the product lifecycle, including clinical trial management, regulatory support, data management, pharmacovigilance, and more.
While some CROs deliver these services as end-to-end providers across all phases of drug development, others may offer more niche expertise, focusing on a specific function, phase, or therapeutic area. Depending on the scope and complexity of a program, sponsors may partner with a full-service CRO or engage niche CROs as and when needed for a more tailored development process.
The key advantages of CRO partnerships for sponsors are flexibility and scalability. Sponsors can scale their CRO services up or down depending on the size, phase, or scope of a study, allowing them to expand or contract support based on real-time needs. This adaptability helps companies reduce overheads and stick to timelines, while maintaining high-quality execution.
CRO services can cover every phase of drug development, offering the scientific expertise and operational infrastructure needed to keep programs on track across stages (Figure 1). Their involvement can begin in the preclinical phase, where they can provide early safety and pharmacology studies to lay the foundation for human trials.
In clinical development (Phases I–III), CROs will provide assays & technologies to monitor drug safety and efficacy, and improve patient stratification during trials. These services can be further supported with clinical sample management and advanced data analysis. In regulatory submission, CROs can prepare and submit the necessary documentation to gain regulatory approval.
Even after approval, CROs often support post-marketing efforts, including long-term safety studies and real-world evidence generation.
Figure 1: CRO services offerings at each stage of development
There are numerous strategic and operational benefits of using a CRO, especially when compared to building in-house capabilities.
By leveraging CRO partnerships, sponsors can focus internal resources on strategic priorities while benefiting from expert-driven drug development services.
Choosing an appropriate CRO partner for your needs is essential for streamlined drug development, and there are several key things you should consider when evaluating CROs.
The role of CROs in drug development is evolving as clinical trials become more complex and technology-driven.
CROs are increasingly integrating AI and big data to enhance data analysis, enabling deeper insights and to support clinical trial decisions.
We are also seeing a shift towards long-term collaborations between sponsors and CROs. Instead of engaging vendors on a study-by-study basis, many sponsors are establishing multi-year collaborations with CROs that can provide consistent support across their entire pipeline.
As the drug development landscape continues to evolve and grow more complex, partnering with the right CRO is vital. The right partner brings the expertise, infrastructure, and flexibility needed to navigate each phase of development with speed and confidence. Whether you’re exploring outsourcing for the first time or reevaluating your current strategy, choosing a CRO that aligns with your goals can make a measurable difference in trial outcomes and timelines.
CellCarta is a global contract research organization (CRO) supporting drug development from discovery to late-stage clinical testing. We offer biomarker testing, clinical sample management, and regulatory support to help sponsors move the drug development program faster with confidence.
Speak with one of our experts to learn how our CRO services can support your next program.
About the author
Stephanie Marmen is the Global Marketing Director at CellCarta, where she oversees all corporate communications and scientific marketing initiatives. She holds a PhD in Biochemistry and brings profuse expertise in immunology, flow cytometry, histopathology, and genomic models. With a background as a scientific communicator for several pharmaceutical companies, particularly in oncology and autoimmune diseases, Stephanie has a strong foundation in translating complex science into impactful messaging. She is especially passionate about scientific communication and exploring how AI can advance medical research.