CrO Biosciences, Inc., (CrO) is an information management consulting firm located in Temecula, CA. We provide regulatory submissions, GCP inspection readiness, clinical trial support, and R&D Systems Exchange services to pharmaceutical, biotechnology, and medical device organizations. CrO is a global, woman-owned, operated and controlled company, which consists of regulatory and clinical operations professionals with over 60 years of combined experience. Our unique methodologies are up to date with the current rules, regulations, guidances, technologies, and latest industry trends keeping us ahead of the curve every time..
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Within the R&D Systems Exchange we specialize in governance, business process development, during configuration activities will ensure you are getting the complete solution. We assist with strategy and roadmap, UAT/PQ validation, data migration prep, Go-Live planning/strategy, and End-user support (Pre- and Post Go-Live). We will align with the software vendor in order to provide the complete solution: whether its to implement a brand-new system with a brand-new process, successfully, the first time or to upgrade or merge existing systems.
Within Regulatory Operations we specialize in the end to end lifecycle of your applications; including the transition from paper to electronic submissions, document formatting, submission publishing, document management including vendor demos, selection, validation and implementation. We have the expertise necessary to acquire agency approval for regulatory applications in biotechnology, pharmaceutical, and medical device organizations.
Within Clinical Operations we have a never-failing approach towards the management of your clinical trials from inception to completion by assessing, creating and implementing a roadmap for document management of the TMF. We assist in standardizing and organizing information in a manner that’s compliant with regulations set forth by the FDA and other regulatory agencies.
We specialize in eCTD submissions. Companies who are already submitting electronically but may need extra submission publishers, we also offer to publish and submit on your behalf as needed.