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CRO Prep Final Exam Questions & Answers 2024/2025
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CRO Prep Final Exam Questions & Answers 2024/2025
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CRO Prep Final Exam Questions &Answers 2024/2025
CRO - ANSWERSContract Research Organization
What is the CRO? - ANSWERSorganisation that supports pharmaceutical, biotech and medical device
industries in the form of research services outsourced on a contract basis
What services may the CRO provide? - ANSWERSbiopharmaceutical development
biologic assay development
commercialization
preclinical research
clinical research
clinical trials management
pharmacovigilance
Many CROs specifically provide clinical-study and ___________-______ support for drugs and/or medical
devices. CROs range from large, international full-service organizations to small, niche specialty groups. -
ANSWERSclinical trial
CROs that specialize in clinical-trials services can offer their clients the expertise of moving a new drug or
device from its conception to ____/EMA marketing approval, without the drug ___________ having to
maintain a staff for these services. - ANSWERSFDA
sponsor
What are the responsibilities of a sponsor when outsourcing clinical research activities to a CRO
(according to IHC-GCP)? - ANSWERSany trial related duty and functions
transferred to and assumed by the CRO should be specified in writing
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