Guideline on computerised systems and electronic data in clinical trials

November 2023 – Mario Corrado, CROss Alliance QA Manager is one the authors of the paper “Analysis of the EMA guidance ‘guideline on computerised systems and electronic data in clinical trials’”.

The work analyses the challenges of the implementation of the recent guidance applicable to Sponsors, Investigators and the pharmaceutical industry. The article has been published on the journal of the Research Quality Assurance Association (RQA) (QUASAR 165, November 2023) and on the journal of the Italian Society of Pharmaceutical Medicine (SIMeF) (Giornale della SIMeF 05/2003)

We are glad to have such relevant expertise in house on a so tricky matter, as usual, we will made available all CROSS’ know how to our clients in the on-going and future clinical trials committed to us.

Have a look at the article at this link: Analysis of the EMA guidance ‘guideline on computerised systems and electronic data in clinical trials’