Data-Focused CRO and its Benefits over Full Service CRO

A data-focused CRO usually consists of a multi-sectoral team of specialists in biostatistics, statistical programming, clinical data processing, and medical writing.

FREMONT, CA: A full-service Clinical Research Organization (CRO), also known as a Contract Research Organization, is an organization that helps pharmaceutical, medical device, biotechnology, and nutraceutical companies (also known as sponsors) produce, evaluate, and bring new drugs/devices to market by providing clinical and data services.

On the other hand, a data-focused CRO is solely concerned with the data and not with the organization, production, marketing, or patient recruitment of clinical trials. A data-focused CRO usually consists of a multi-sectoral team of specialists in biostatistics, statistical programming, clinical data processing, and medical writing. Each specialist in these departments collaborates across departments to ensure that a sponsor's medicines reach patients quickly and safely. To assist sponsors, a data-focused CRO usually has three sourcing offerings. These include:

• Centralized Service Provision-With this option, the sponsor partners with a single organization that handles all of the sponsor's tasks.


• Full-Service Approach-Sponsors may partner exclusively with one or two vendors who will provide services for the entire study/portfolio for this offering.


• Functional Service Provider (FSP)-Here, instead of delivering all resources for the entire

 clinical development program, the CRO offers basic functional services to add to it.

Internal guidelines and operating procedures mandate and govern cross-departmental cooperation in such a CRO. A medical writer, for example, will collaborate on a protocol with a statistician, who will provide insight into study design and statistical methodologies.

Benefits of A Data-Focused CRO

So, what are the advantages of outsourcing a data-focused niche CRO rather than a full-service CRO?

• Companies in the biotech, pharmaceutical and medical device industries tend not to hire specific service providers or have to manage all of them. It is also possible that they won't be able to recruit the necessary experts in-house. Instead, they can rest assured that they will receive a high-quality and versatile service if they go to a data-focused CRO.


• Decisions are also made faster in data-driven CROs, which have more nimble cultures due to effective cross-team communication. As a result, many efficiencies are allowed, reducing task times and improving governance.


• A long-term relationship with such a CRO that spans many studies guarantees even shorter learning times, which saves time for sponsors.


• Since data-focused CROs concentrate on one area (data) rather than being spread thin over several areas, they are often praised for providing high-quality results for sponsors. Alternately, full-service CROs are often so dependent on clinical surveillance that high-quality clinical data can be an afterthought.


• It's critical to have consistency in data mapping, standardization, and analysis when outsourcing multiple studies, particularly for CDISC submissions, across study SDTMs (Study Data Tabulation Models) and ADaMs. Outsourcing multi-study studies to a single data-focused CRO ensures accuracy and compliant data that is ready for submission.