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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:
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?