A study sponsor is exactly what it sounds – they sponsor, or take responsibility for and initiates a clinical research study. A study sponsor can be a pharmaceutical company, governmental agency, academic institution, person, group or private organization. The sponsor does not actually conduct the investigation (that occurs at a research site like Rochester Clinical Research).
When a sponsor initiates a clinical research study, they are required to have a protocol. A protocol is an official document that describes the background, rationale, and objective of the study. Once that is established it goes into detail of how a clinical trial will be conducted. This includes the required timelines, procedures, and how subjects document any necessary information. It also describes who can and cannot participate based on the study inclusions and exclusions. All protocols must be IRB approved, which ensures the safety of subjects and the integrity of the data collected.
Once the study is underway, a sponsor ensures that good quality management and monitoring systems are in place. They also ensure protocol compliance so they are able to give clean data to the FDA to continue on to the next phase of research.
To see a list of study sponsors we have worked with in the past, please click here. Please note, this list may not include all sponsors we have worked with.