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St. Louis Park, MN - Frestedt Inc. is pleased to announce Adam Zhang has been recertified as a Certified Clinical Research Associate (CCRA) by the Association of Clinical Research Professionals (ACRP). As a CCRA, Adam provides critical functions for clinical research by monitoring GCP compliance, protocol compliance and data quality for Frestedt Inc. clients.
Experts in clinical evaluations, Frestedt Inc. recently completed review of another Investigational New Drug (IND) amendment for the United States (US) Food and Drug Administration (FDA) including protocol, informed consent form (ICF), investigators brochure (IB) and new site investigators while also issuing an interesting CER (Clinical Evaluation Report) to ensure a device meets safety and performance requirements in Europe. Since March 2020, Frestedt Inc. has been continuously registering establishments and listing product labels with FDA for COVID-19-related products to help get new, urgently-needed products to market.
If you need help in any of these areas Frestedt is ready to provide services.