A Contract Research Organization, or CRO for short, is a company that helps other organizations, like pharmaceutical or biotech companies, manage and conduct clinical trials. Instead of doing everything in-house, companies partner with a CRO to handle responsibilities such as planning the study, recruiting patients, collecting and analyzing data, ensuring regulatory compliance, preparing clinical reports, or managing trial sites – among other things. It’s an effective way to save time and resources while bringing new treatments to market faster.

CROs come in all sizes, from large, full-service providers to smaller organizations that focus on specific niches. Smaller CROs often specialize in a single therapeutic area. For example, a biotech company developing a new Glaucoma treatment might partner with a smaller CRO specializing in ophthalmology trials. Instead of managing the trial in-house, the company relies on the CRO’s deep expertise in ophthalmology clinical research and the ability to tap into their established relationships with high performing clinical research sites to ensure optimal results. Larger CROs, while capable, may lack the same level of specialized focus, potentially slowing down the trial process. They are often the better suited to complex trials that span multiple countries and require expertise in different areas, such as logistics, regulations, and different therapeutic specialties.

What Services Can a CRO provide?

Ultimately, choosing the right CRO depends on the trial's needs - whether it’s specialized focus or the capacity to handle large-scale, complex studies. Let’s take a look at some of the services a CRO is capable of providing to help you get a better understanding.

• Clinical Trial Management
• Preclinical Research
• Regulatory Affairs
• Data Management & Biostatistics
• Medical Writing
• Site Recruitment
• Patient Recruitment & Retention
• Site Management
• Pharmacovigilance
• Biomarker Development
• Real-World Evidence (RWE) Analytics
• Post-Market Surveillance
• Clinical trial transparency and disclosure

Differences Between Staffing, Clinical Consulting, and CRO?

You may be wondering how a CRO differs from a traditional staffing or consulting agency if they all provide specialized personnel to solve complex problems centered around drug development. Large CROs can run a fully outsourced product lifecycle. From preclinical up and until commercialization, they could handle every aspect of clinical development without the need to ever go outside the organization. They often own their own technology licenses or have a proprietary CTMS. This could be appealing to a company that doesn’t want to spend money on a permanent space or is focused on getting a single asset across the finish line.

Clinical consulting and staffing agencies are slightly different but often share the same goals. Consulting companies are often brought on a contracting basis to solve a specific problem for a specified period of time. Once the problem is solved, they move on to the next opportunity. A staffing agency is focused on filling new headcount on a permanent or contract basis. They support the long-term growth of the company and are often an extension of the internal talent acquisition strategy.

The reality is most companies will use a mix of CROs, clinical consultants, and staffing agencies to solve various challenges during the drug development process.

Areas of Improvement for CROs

For many in the clinical research community, the perception is that it doesn’t matter what CRO you go to, you will get the same lousy service by overworked employees trying to do their best with limited resources. Often, a CRO is where many professionals begin their careers in clinical research, so some study team members may have limited experience. This learning curve comes at a high cost because running a trial through a CRO entails a significant investment.

Sponsors pay for access to site networks, patients, and expertise, all of which come at a high cost. Bringing a drug to market costs around $1 billion, with a significant portion going to CROs. Staffing trials presents another challenge. Larger sponsors with bigger budgets receive priority, leaving smaller organizations with fewer options. This can result in longer timelines, poor study design, and higher failure rates due to inadequate preparation. CROs and sponsors may also clash over control of key study aspects, leading to quality issues, high turnover, low morale and unplanned protocol deviations that compromise data integrity.

Emerging Trends DRIVING CLINICAL TRIAL SUCCESS

It’s no secret that fully outsourced clinical trials are becoming a thing of the past, with the exception of vaccines. For the last 20 years, sponsor companies have been shifting towards a Functional Service Provision (FSP) model because it offers a more flexible outsourcing approach while simultaneously allowing them to retain control over employees and data. FSP employees are fully embedded into the sponsor company, with company email addresses and no communication barriers.

There is a blending of staffing and consulting agencies into more dynamic organizations that shoulder some of the burden from the CRO. As the budget for agency spend has gone down since the COVID staffing frenzy, sponsors are investing more heavily into contract recruiters, beefing up their internal teams, and relying more heavily on the CRO which is typically in a different spending category.

Closing Thoughts

The drug development landscape is complex and expensive. A successful sponsor will rely on a combination of outsourcing strategies to bring a new drug to market. The CRO remains an integral part of driving innovation and maintaining access to a global network of patients. The most important aspect of selecting the right CRO partner is aligning expectations and goals with a likeminded organization. Once completed, looking around for a trusted staffing partner to help your company continue to grow as needed will be critical.