In the competitive clinical research industry, large, multinational contract research organizations (CROs) often dominate the conversation. Their expansive global networks, extensive staff, and broad service offerings are frequently seen as benchmarks for capability. However, smaller CROs are increasingly demonstrating that the ability to deliver complex studies is not determined by size, but by focus, expertise, and execution.
AXIS Clinicals CEO Dinkar Sindhu believes that rather than the size of a CRO, it is the impact that matters.
“Size doesn’t define capability. Focus does,” Dinkar states.
Beyond Headcount and Global Reach
Industry experts point to several performance indicators that hold more weight than organizational scale when evaluating a CRO. These include the strength of regulatory compliance systems, the ability to meet aggressive patient enrollment timelines, the degree of direct oversight from senior leadership, operational agility when faced with protocol changes, and the quality of communication and risk management between sponsor and CRO.
Another critical measure is whether a CRO prioritizes the number of studies it can take on or the impact it can create with each project. Organizations that opt for targeted execution often see fewer delays, higher data quality, and improved client satisfaction.
Specialization as a Competitive Advantage
Some smaller CROs have found success by focusing on a narrow set of trial types rather than expanding into every therapeutic area and phase. Early-phase pharmacology trials—particularly those involving healthy volunteers and special populations—are one example where specialization can yield significant advantages.
By concentrating resources, training, and infrastructure on one specific area, these CROs develop deep operational expertise and streamline processes to meet the unique demands of early-phase work. This specialization allows for faster adaptation to study needs, cleaner data, and more consistent regulatory outcomes.
Agility in a Changing Environment
Flexibility is a defining advantage for smaller organizations. In early-phase research, changes to protocols, dosing schedules, or enrollment windows are common. Larger CROs often face internal approval layers that slow decision-making, whereas smaller CROs can pivot quickly, implementing adjustments without long delays.
This adaptability is particularly valuable when recruiting from small or specialized patient populations, where timing can be critical. The ability to make rapid operational changes can prevent setbacks that might otherwise disrupt study timelines.
The Value of Leadership Involvement
Senior leadership engagement is another factor that can distinguish smaller CROs from their larger counterparts. In many smaller organizations, senior executives maintain direct involvement in projects, overseeing execution and maintaining regular contact with clients. This can result in more responsive communication, faster problem-solving, and a stronger sense of accountability throughout the life of a study.
For sponsors, this can mean fewer miscommunications, clearer expectations, and swifter resolution of any emerging issues.
Partnership Over Transaction
Strong sponsor-CRO relationships are built on proactive risk management, transparency, and open communication. Smaller CROs often prioritize this approach, positioning themselves as partners in the success of a study rather than just service providers. By fostering collaboration, they can address potential challenges before they become delays or compliance issues.
Impact Over Volume
While large CROs may handle dozens of studies across multiple therapeutic areas at once, smaller CROs can benefit from concentrating on fewer, more specialized projects. This approach enables tighter quality control, greater consistency, and more personalized service for each client. For sponsors focused on specific study phases or niche therapeutic areas, the advantages can outweigh the benefits of working with a larger organization.
Changing Perceptions in the Market
The shift toward recognizing the capabilities of smaller CROs reflects broader changes in how sponsors approach outsourcing. Increasingly, the focus is on measurable performance metrics—such as enrollment speed, regulatory success rates, and data quality—rather than company size alone.
AXIS is one such company focusing on impact over size. “We’ve chosen to stay focused on early-phase pharmacology trials- especially healthy volunteer and special population studies. That’s all we do. And that’s why we do it well,” Dinkar explains.
For complex early-phase studies, in particular, the right combination of specialization, operational agility, and leadership involvement can be more valuable than having a vast global infrastructure. As the CRO market continues to evolve, more sponsors are looking beyond the traditional “bigger is better” mindset and evaluating partners on the results they can deliver.
About Dinkar Sindhu
Dinkar Sindhu is a seasoned executive with over two decades of experience in building, scaling, and optimizing organizations across various stages of growth. He has developed and implemented comprehensive business and organizational design strategies, guiding companies through all phases of operational maturity.
As the CEO of AXIS Clinicals in the USA, Dinkar leads the company’s strategic vision and global growth initiatives. Under his leadership, Axis Clinicals has strengthened its position as a trusted provider of early phase clinical trial services, advancing high-quality, regulatory-compliant solutions for pharmaceutical and biotech partners worldwide.
Previously, Dinkar has held leadership roles in the CRO, pharmaceutical, engineering, and railroad industries, with a strong track record in international commercial operations, business development, and general management.