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CRO Prep Final Exam Questions & Answers 2024/2025 $7.99   Add to cart

Exam (elaborations)

CRO Prep Final Exam Questions & Answers 2024/2025

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  • CRO Prep

CRO Prep Final Exam Questions & Answers 2024/2025

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  • August 5, 2024
  • 2
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
  • CRO Prep
  • CRO Prep
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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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