Before we delve into what a data-focused Clinical Research Organization (CRO) is, let us first explore what a full-service Clinical Research Organization is.
A full-service Clinical Research Organization (CRO), also referred to as a Contract Research Organization, is an organization that supports pharmaceutical, medical device, biotechnology and nutraceutical companies (also known as sponsors) in developing, testing and bringing new drugs/devices to market, typically through a full range of clinical and data services.
In contrast, a data-focused CRO purely focuses on the data and not on the organization, manufacturing, marketing or patient recruitment of clinical trials.
Typically, a data-focused CRO is made up of a team of experts that offer multi-sectoral services in biostatistics, statistical programming, clinical data management and medical writing. Each expert within these departments works across functions to ensure a sponsor’s medicines are brought to patients efficiently and safely.
A data-focused CRO typically has three sourcing offerings to support sponsors. These include:
Such a CRO has internal guidelines and operating procedures in place that mandate and regulate across department collaboration. For instance, a medical writer will write a protocol in collaboration with a statistician who will offer insights on study design and statistical methodologies.
Benefits of a data-focused CRO
So, what are the benefits of outsourcing to a single data-focused niche CRO VS a full-service CRO?