Explore the pros and cons of outsourcing clinical trials to Contract Research Organizations (CROs) versus conducting them in-house. Discover key factors to consider for successful trial management.

The clinical trial process is an essential milestone to bringing novel drugs and therapies to market. Sponsors must also decide whether to perform these trials themselves or outsource them to a contract research organization (CRO). Each comes with its own advantages and disadvantages, and the best choice is highly dependent on several project-specific factors. 

In-House Pros:  

Maximise Control: Keeping work in-house enables greater control over all parts of the trial design, delivery, and results data. 

Communication — Direct communication between researchers and clinical trial staff can lead to quicker decisions and problem-solving. 

Institutional knowledge — An in-house team may have a better understanding of the compound being developed which could lead to faster and more effective trial execution. 

In-House Cons: 

Increased Costs: To construct and upkeep an in-house clinical research team is costly, especially for smaller companies. 

Lack of expertise: Some small to mid-sized companies may lack experience with the specific therapeutic areas they are entering into for global trial execution. 

Scalability Challenges: It can be complex to keep track of a large number of trials at the same time with a limited in-house team. 

One option for dealing with this dilemma is to outsource this function by engaging a CRO. 

Outsourcing Pros: 

Affordable: A good solution for small businesses considering outsourcing. Sponsors Pay Only for Required Services 

Quality of resources: CROs have access to a larger talent pool of professionals across different areas and can help in the global management of a trial. 

Quick Trial Start: CROs have existing networks and systems that help them to quickly start and complete the trial. 

Outsourcing Cons: 

Loss of control- Outsourcing to a CRO comes with loss on the amount of control we have over the trail. Communication transparency is an important thing and good project management for different phases to manage transactions provides a clear roadmap for auditability and visibility. Communication gaps between sponsor and CRO can delay the trials. 

Increase in Overall Costs: The fact that CRO fees may turn out lower does not mean overall costs are reduced when you factor in all the additional costs that come with setting and monitoring the contracts. 

Conclusion 

Making the Right Choice 

Whether it is best to outsource or get your feet wet with clinical trials depends on a few things including: 

Company size and resources 

Complexity of the trial 

Therapeutic area expertise 

Budgetary constraints 

Desired level of control 

Most firms take a hybrid approach: they use in house knowledge alongside with what CRO services already have to offer. We provide a number of functions so that this can be customized for your project. 

To learn about how we can help your organization, get in touch with BioBoston Consulting today or visit our website.