Canada Seeks To Make Decentralized Trials More Practical For Sponsors
MHRA Points To Existing Flexibilities In UK Regulations To Enable Remote Studies
By formally adopting a modernized definition of a clinical trial site, Health Canada is hoping to provide greater flexibility to sponsors who want to incorporate decentralized elements in their trials.
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The UK regulatory agency, the MHRA, is planning to establish a “world-class sovereign regulatory environment” for clinical trials to support the development of new innovative medicines. In the first of two articles, we look at the MHRA’s proposals to slim down trial approval processes, lighten the safety reporting burden, and introduce greater transparency of trial registration and results.
Updated UK guidance describes the factors that clinical trial sponsors and investigator sites must consider when giving appointed representatives direct access to the electronic health records of participants in clinical trials to check source data.
Consultancy firms must have at least five years of experience in carrying out independent GMP or GDP audits if they want to apply to become a “compliance monitor” under a new MHRA scheme to keep track of drug companies that fail to comply with GMP/GDP requirements.