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:
- Centralized Service Provision - with this offering the sponsor works with one company who looks after specific tasks across functions
- Full Service Approach - with this offering sponsors will work exclusively with one or two vendors who will provide services for the whole study/portfolio
- Functional Service Provider (FSP) - here the CRO provides specific functional services to contribute to an entire clinical development program, rather than providing all services for the whole program
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?
- Biotech, pharma and medical device companies prefer not to commit to hiring individual service providers, nor do they favor having to coordinate all these providers. It also might not be feasible for them to hire the experts needed in-house. Instead, by going to a data- focused CRO they can get peace of mind that they will receive a high-quality and flexible service.
- Decisions are often made quicker in data-focused CROs, where the cultures are often more nimble due to efficient cross team communication. This in turn enables many efficiencies that significantly reduce task times and improve governance.
- A long-term relationship with such a CRO, spanning multiple studies, ensures even shorter learning periods, saving sponsors time.
- As data-focused CROs specialize in one area (i.e. data) and aren’t spread thin across a range of different areas, they are often highly regarded for delivering high quality results for sponsors. In contrast, full-service CROs are often so focused on clinical monitoring that high quality clinical data may come as an afterthought.
- When outsourcing multiple studies, it’s important to have consistency in data mapping, standardization and analysis, particularly across study SDTMs and ADaMs for CDISC submissions. Outsourcing multi-study projects to a single data-focused CRO ensures that consistency is guaranteed, and data is compliant and submission-ready.