From Providers to Partners: The Evolving Role of CROs in Drug Development
The role of CROs in drug development will continue to grow as clinical trials evolve therapeutically and geographically.
As biopharmaceutical pipelines grow more complex, the role of contract research organizations (CROs) is undergoing a fundamental shift.
Once viewed primarily as service providers for single drug development functions, CROs can now deliver scientific insight, regulatory strategy, and operational excellence from discovery to approval and post-market surveillance.
Few leaders have witnessed—and helped shape—this transformation as closely as Barbara Lopez Kunz, chief executive officer of Caidya, and Dr. Fabrice Chartier, chief executive officer of Simbec-Orion. With decades of experience in therapeutic innovation and global trial execution, both executives spoke with Technology Networks following their strategic combination to explore how CROs are evolving to meet the demands of the biopharmaceutical space.
CROs have moved from service providers to strategic partners
Historically, CROs played a limited, largely transactional role in drug development.
In the 1940s, sponsors engaged CROs to provide additional operational capacity. What started as the provision of animals for testing or the conduct of preclinical studies later grew into broader support, especially following the introduction of rigorous regulatory standards in the 1960s.
CROs were forced to formalize, but instead of limiting their scope, they used the opportunity to broaden their capabilities. With defined standards, they were able to strategically and safely move into functions such as clinical trial logistics, data management, and statistics.
The end of the twentieth century saw the approval of blockbuster drugs, defined as those that bring in annual sales over $1 billion today, like statins and antidepressants. As the industry boomed, demand increased, and opportunities for CROs continued to grow.
Chartier reflected on their current capabilities: “Today, sponsors increasingly rely on CROs as strategic partners instead of simply providers of resources.”
“CROs are now expected to contribute scientific and therapeutic expertise, country-specific regulatory knowledge, and strategic guidance that helps inform decision-making throughout the drug development process,” he continued. Such decisions had previously been down to sponsors.
As advanced therapies become more prevalent, CROs are increasingly expected to collaborate with sponsors rather than act as independent vendors. “By acting as an extension of the sponsor's team, CROs can provide strategic expertise from protocol design through study execution, help manage the unique challenges associated with advanced therapies such as gene therapy and gene editing, and integrate seamlessly with sponsor teams rather than operating independently,” Kunz explained.
CROs play multiple roles in drug development:
- CROs contribute directly to scientific and strategic decision-making, not just execution.
- Therapeutic complexity has increased demand for specialist expertise, but it isn’t the sole reason for increased CRO responsibility.
- Strategy and knowledge that spans regions has become a core CRO capability.
The link between early CRO involvement and success
Now that CROs have been acknowledged as partners, it is crucial that they are integrated into studies early.
A poorly designed protocol, the blueprint of a clinical trial, can lead to delays, regulatory issues, and even trial failure. Pre-empting potential issues should be built into the planning stage, allowing problems to be prevented rather than remediated. Especially when the stakes may not allow remediation at all.
CROs bring a unique perspective during the planning stage, drawing on extensive historical data and operational expertise. Unlike start-ups launching a new venture or academic sites with limited resources, CROs can accurately forecast timelines, optimize protocols, and streamline site selection based on experience across numerous studies.
This experience is equally valuable for large pharmaceutical companies. Although they often possess significant internal knowledge, partnering with a CRO provides an external perspective, helping to de-risk critical decisions while maximizing the likelihood of successful study execution.
“Early collaboration enables stronger protocol design, a clear understanding of the most appropriate regulatory pathway, comprehensive feasibility assessments, and the identification of the right clinical sites and patient populations,” highlighted Kunz.
“By addressing these critical elements early, sponsors can proactively reduce project risk and improve the likelihood of successful study execution.”
Why early collaboration matters:
- Improves protocol quality and feasibility.
- Enables stronger site and patient selection.
- Reduces risk of costly mid-study adjustments.
Managing complexity without compromising speed
As therapeutics become increasingly complex, the pressure is on CROs to maintain both speed and scientific rigor.
Chartier noted that this pressure is especially evident in early development, where a deeper understanding is required as therapeutics are used in humans for the first time.
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Unlike a traditional drug compound trial, in which participants receive standardized therapy manufactured at scale, biopharmaceutical trials introduce additional logistical and pharmacological complexities. For example, autologous cell therapy trials require the collection of a patient's own immune cells, genetic modification in specialized manufacturing facilities, and then reinfusion into the same patient.
At the same time, advanced therapies also pose a risk of severe, sometimes hard-to-predict, adverse events, which must be accounted for in planning.
“Successfully balancing rapid execution with scientific rigor remains one of the industry's greatest challenges.” — Dr. Fabrice Chartier.
“This growing complexity demands more specialized training for study teams, greater expertise in interpreting sophisticated protocols, and the ability to maintain operational speed without compromising quality,” noted Chartier.
Operational challenges CROs must address:
- Upskilling teams to interpret complex scientific data.
- Increasingly complex logistical requirements.
Navigating global regulatory variability
The challenge of increasing therapeutic complexity is compounded by the increasing geographic distribution of drug development.
This requires sponsors and CROs to coordinate patients, investigations, and regulatory requirements across multiple countries and healthcare systems.
Kunz emphasized the importance of combining global infrastructure with local expertise: “Managing regulatory variability requires both a broad global footprint and strong local expertise.”
“CROs must have experienced teams across key regions, including the United States, Europe, Asia-Pacific, Australia, and China, while also maintaining in-country regulatory specialists who understand local requirements.”
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Drug regulation and approval varies across the globe
Pharmaceutical regulation is overseen by various bodies worldwide, such as the Food and Drug Administration, which approves drugs in the United States, and the European Medicines Agency and Commission in Europe. Documentation standards, trial types, and acceptable endpoints vary across bodies and can impact study timelines, design, and ultimately, the outcome.
The International Council for Harmonisation was established to provide uniform guidance and approval criteria worldwide (and to avoid duplication of effort). While most new drugs now achieve concordant approvals across bodies, regions still differ in their clinical trial expectations and timelines.
Historically, CROs had strong regional connections. This provided them with deep local expertise and the ability to align development efforts with regional regulatory requirements. Regional knowledge also helped with patient recruitment, as population-specific motivators and barriers could be considered in trial recruitment and conduct.
As CROs from different geographic regions are now combining efforts, Kunz reflected on the benefits: “Combining global reach with local knowledge enables CROs to guide sponsors toward the most effective regulatory strategy for each region.”
Benefits of combining regional expertise:
- Ability to adapt to local requirements, which supports trial success from recruitment onwards.
- Local expertise can be paired with consideration of requirements in different regions, supporting global success.
CRO-led drug development could be the future
Ultimately, the transformation of CROs from providers to partners, combined with their geographic expertise, is reshaping drug and biopharmaceutical innovation. As CROs join forces, they provide an opportunity for more coordinated, efficient, and globally scalable drug development.
“This collaborative approach helps reduce development risk, improve efficiency, and accelerate the successful delivery of innovative therapies to patients,” concluded Kunz.
Key takeaways:
- CROs have evolved into strategic partners, playing a central role in decision-making across the drug development lifecycle.
- Early and integrated collaboration improves trial design, reduces risk, and accelerates execution.
- Balancing scientific complexity with operational speed will define CRO success in the coming years as research into advanced therapies continues to grow.
This content includes text that has been created with the assistance of generative AI and has undergone editorial review before publishing. Technology Networks' AI policy can be found here.
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