Contract Research Organization

What is a Contract Research Organization?

A Contract Research Organization, or CRO, is a company contracted by pharmaceutical, medical device and biotechnology companies, also known as a sponsor company, to perform the services needed on individual clinical trials or to help with new therapeutic product submissions to regulatory agencies, such as the US FDA. Throughout the drug development process many sponsor companies choose to outsource services to CROs, like Veristat. For Clinical CROs, services are outsourced starting from Phase I ( first studies in human subjects), through to Phase III (confirmatory studies), and onward to FDA submission. Contract Research Organizations operate under both FDA and international clinical research standards (ICH guidelines) as well as company internal Standard Operating Procedures (SOPs).

Services offered by a full service Contract Research Organization, such as Veristat, include Clinical Monitoring, Consulting Services, Safety Management, Data Management (both paper case report form and electronic data capture {EDC} based), Biostatistical and Programming services, CDISC Implementation, Medical Writing, data monitoring committee (DMC) assistance, Full Program Management and FDA Representation. Since 1994 Veristat has grown as an industry leading, full service CRO with extensive therapeutic experience and continued commitment to scientific excellence in clinical research.