What is a CRO

A Contract Research Organization (CRO) is an organization that offers clients a wide range of pharmaceutical research services. In the Code of Federal Regulations (CFR), the U.S. Food and Drug Administration (FDA) regulations state that a CRO is "a person [i.e., a legal person, which may be a corporation] that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration." [21 CFR 312.3(b)]

Services offered by CROs include: product development and formulation, clinical trial management (preclinical through phase IV), central laboratory services for processing trial samples, data management services for preparation of an FDA New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA), and many other complementary services. CROs can offer their clients the experience of moving a new drug from its conception to FDA marketing approval without the drug sponsor having to maintain a staff for these services, which often have limited duration. [1]

Read more: http://en.wikipedia.org/wiki/Contract_research_organization

Why Synteract

More than just a consulting firm, we are a partner to you. Think of us as a guide that helps you through the clinical trial process – not just a company with boilerplate models and “one-size-fits all” templates. We empower you to have the best possible experience with performing clinical trials for your drug or device program.

We have a successful track record in managing clinical trials, with over 13 years of drug industry experience and a solid reputation for understanding the burdens of small emerging firms as well as large pharmaceutical organizations. Our diverse methods and robust infrastructure allow you to face the challenges inherent with all studies, and effectively adapt to the specific needs of each study. Check out our capabilities: Services and Clinical Applications.

How To Succeed

Quality, timely, proven results. At Synteract, our mission is to help our clients achieve their goals by providing impeccable services, meeting the aggressive timelines, while continually focusing on their specific needs. We can help with all phases of clinical trials, from start-up to post-market.

We share your work, we share your vision – enabling you to succeed.