The Pros and Cons of Using a CRO: The Basics and More

Many companies that are in the process of developing new medicines might outsource work to a Contract Research Organization (CRO). 

This decision was possibly made to save money, to guarantee work completed within time and budget constraints, or to benefit from industry expertise. 

So what exactly is a CRO and what are the benefits and challenges of outsourcing work to them?

CROs are organizations that provide support and services to the medical device or pharmaceutical industries. They are usually hired on a contractual basis to provide services during the development stages. Some CROs will be able to help with all steps of development, from conception to approval, while others specialize in niche jobs like clinical studies and trials. 

The first and most evident benefit of outsourcing work to a CRO is having another entity conducting some or all duties that need to be completed. CROs will already have the staff in place, the experience and equipment needed, and any necessary resources prepared. Not having to prepare all of this will most likely save a company time and money.

Time sensitivity is a large benefit because CROs are set up and prepared to start work as soon as a contract is signed. No time delays will be necessary to wait on hiring, fundraising, or clinic preparation. 

If the medicine or device being developed is expected to be approved in a variety of nations or locations, it will be beneficial to hire a CRO that has international experience with the approval process in each jurisdiction. The contracted CRO can have facilities and staff already located in the target location and will have knowledge about local regulations for clinical studies and ultimate approval. 

Outsourcing work to another organization always comes with its challenges, with the most obvious being a lack of direct oversight. Another team in another location is conducting the work so day-to-day supervision is impossible. 

Without direct oversight, the consequences of any problems or failures will still fall on the company hiring the CRO. Using a CRO does not mean guaranteed success or approval and the company will still have to deal with any financial burdens born out of a failed study. 

Contracts with CRO usually include multiple audits before and during every step conducted. While this provides some level of oversight, it is an important aspect of the process to consider when choosing a CRO or if using one is even the right decision. 

Confidentiality is the final major issue when discussing the challenges of outsourcing work. A company is sharing intellectual property and other confidential information with an outside organization and this can be seen as a major risk. Confidentiality agreements play a large role in offsetting this challenge but being cognizant of different laws in different countries is very important. 

Are you looking to learn more about CROs and how they can benefit your organization. Then check out our Selecting and Managing CROs training course.

Our CRO training course will help explain the specific methodology and management techniques to successfully outsource pharmaceutical programs to CROs. This course is designed for personnel in the pharmaceutical, biotechnology, medical device, and biologics industries who use CROs in the process of developing their products for FDA approval.

Have questions? Get in touch with a member of the CfPIE team by calling 1-610-648-7550 or emailing [email protected].