As a newer sponsor eager to bring your therapy to the hands of patients, or one that’s had generally negative experiences working with contract research organizations (CROs), you may find yourself thinking, “can we just do this ourselves?” as you start to think about planning for your next clinical trial. The decision of whether to manage your study in-house or outsource responsibilities to a CRO is one that can significantly impact efficiency, cost, and much more.

Control and Oversight

Sponsors may opt to manage their research entirely themselves when they want to maintain full control. This tighter oversight can be particularly useful in the following scenarios:

• Innovative Therapies or Unusual Trial Designs: Trials for new therapeutic modalities (e.g., gene therapies, cell-based treatments, digital therapeutics) or highly innovative trial designs (e.g., adaptive trials, decentralized trials) often require very close oversight. Sponsors with in-house expertise are better positioned to manage the nuances and complex requirements of such trials.
• Highly Sensitive or Proprietary Research: For trials involving highly sensitive data, such as research on new drug targets, genetic information, or digital biomarkers, sponsors may prefer to keep control over all trial processes to safeguard intellectual property and proprietary knowledge.
• Early-Stage Biotech Companies: Startups or biotech companies in early stages of drug or device development may benefit from keeping their trials in-house. These companies often need to pivot quickly based on early results and investor pressure, making in-house management more effective for rapid decision-making and protocol adjustments.

While this level of oversight allows you to be more responsive, adaptive, and aligned with your trial’s specific needs, it also requires that you have the necessary expertise, infrastructure, and resources to effectively manage all aspects of your trial without compromising quality or compliance.

Working with a CRO, however, can significantly reduce the burden on internal study teams. It’s a misconception that once you outsource essential responsibilities to a CRO that they are the ones in control of your study, but at the end of the day, it’s still your study and you and you have the final say on all matters. By facilitating consistent and clear communication with your CRO throughout your trial, you can still give direction on how to approach key aspects of trial execution and maintain control and oversight.

Working with a CRO also means sponsors don’t have to be experts in all aspects of trial execution. 

Budget Considerations

Conducting a clinical trial in-house can be perceived as more cost-effective, especially if you already have the necessary infrastructure and experienced personnel to effectively run your study. If you don’t, hiring can be costly and time-consuming, and you may not know exactly what kind of experience you need new personnel to have under their belts if you’re new to running clinical trials.

It’s also crucial to ensure you have the runway to account for any additional costs that incur. For example, it may take several iterations to complete the build of your Electronic Data Capture (EDC) system, or you may encounter missteps throughout the process that necessitate additional costs to remedy. If you choose to run your study in-house, it’s crucial to be certain you have the cash runway to account for anything that can happen.

In contrast, CROs often operate with economies of scale, which can make them more cost-efficient, especially for large-scale or multicenter trials. Clinical trials is the name of their game, so they already possess the experienced personnel and resources necessary to provide input on study design, regulatory affairs, and more to set studies up for success and prevent extraneous costs down the road.

Expertise and Experience

Running a clinical trial internally can be an eye-opening experience. While you might be really knowledgeable about your product and the therapeutic area it falls in, it may not be enough to execute a clinical trial yourself. Conducting a successful clinical trial is no easy task, and requires experienced staff to handle the various aspects of study execution and navigate challenges that come up.

CROs offer invaluable assets—from protocol generation through data delivery and everything in between—they bring to the table various study teams that are each specialized in managing different kinds of activities. CROs also leverage site networks they regularly work with, unique approaches to patient recruitment and retention, and industry knowledge of regulatory affairs and specific disease indications. Their breadth of experience equips sponsors with everything they need to accomplish milestones as smoothly as possible, and sometimes even accelerate study timelines.

Time and Resource Allocation

Running a trial internally can be resource- and time-intensive, requiring ongoing management and coordination of multiple aspects of the trial. For sponsors with limited infrastructure and/or experience to adequately support trial management responsibilities, this can lead to delays and potential bottlenecks. As noted before, you can bring on more staff, but the hiring process can take several weeks to months to find the right fit. 

Furthermore, tasks like site management, monitoring, data cleaning, and others that are typically handled by CROs can be incredibly tedious, taking away valuable resources from other essential responsibilities. Bringing on a CRO helps alleviate the burden of these tasks, allowing sponsors to focus more on internal operations and bigger-picture items.

Conclusion

Deciding whether to manage your clinical trial in-house or partner with a CRO is a critical choice that hinges on your resources, expertise, and the specific needs of your study. Managing a trial internally offers sponsors full control and the ability to be highly responsive, but it requires significant investment in infrastructure, personnel, and time. On the other hand, working with a CRO can provide access to specialized knowledge, established site networks, and operational efficiencies, reducing the burden on your team and potentially speeding up timelines.

Ultimately, the decision should be driven by a careful assessment of your organization's capabilities and long-term goals. Whether you choose to go in-house or outsource, what matters most is ensuring that your study is designed and executed to meet regulatory standards, protect participant safety, and deliver reliable data to move your therapy closer to the hands of patients. Clear communication, strategic planning, and ongoing collaboration—whether internally or with a CRO—are the keys to running a successful clinical trial.