What is a Contract Research Organization (CRO)?

In clinical research, a Contract Research Organization (CRO) is a company typically hired by a sponsor to manage clinical research sites conducting a trial, ensuring data integrity and patient safety.

Purpose of a CRO:

A CRO acts as the intermediary between the sponsor and the site. They ensure adherence to the study protocol and address protocol deviations, adverse events (AEs), and serious adverse events (SAEs). Clinical Research Associates (CRAs) are available to support site staff and assist with recruitment if the site isn’t meeting goals.

Role of a CRA:

A Clinical Research Associate (CRA), assigned by the CRO, serves as the primary point of contact for the site regarding study-related questions. CRAs also conduct monitoring visits throughout the study timeline to oversee compliance and progress.

Role of a CRA:

A Clinical Trial Manager (CTM) oversees the overall execution of the clinical trial. They manage timelines, budgets, and resources, and ensure that the study runs smoothly across multiple sites. CTMs work closely with CRAs to ensure that trial objectives are met and regulatory requirements are followed.

Electronic Data Capture (EDC):

CROs use Electronic Data Capture (EDC) tools for data collection, randomization, and protocol requirements. Familiarity with the EDC system ensures smooth participant visits. But if you still get stuck, you can always contact the CRA or refer to the provided sources. One of my favorite resources for a quick recap is the SIV slides. Sometimes, the informed consent form also provides some high-level study information that may be useful to the site staff’s comprehension of the study.  

Email Communication:

Maintaining accurate written communication is critical in clinical research. Email correspondence is often saved for future reference. If a conversation occurs over the phone, it is important to follow up with an email summarizing the discussion to ensure accountability. Sites can sometimes be blamed for issues that arise during a study, so adopting habits like these—along with thoroughly understanding the sponsor-provided protocol—can help protect the site and support accurate decision-making when necessary.