Anonymization process (Section 6.3) To facilitate the companies’ approach to the anonymization process, it is recommended to follow the process described below: Determine the direct identifiers and the quasi-identifiers in the dataset Identify the possible adversaries and plausible attacks on the data and evaluation of the risk of re-identification Consider… read more →
To contribute with evidence to the debate on the publication of clinical studies, Maxer chose to share its experiences, involving as witnesses the customers with whom is currently working in the convention Focus on Clinical Trials Transparency and Lay Person Summary that will take place in Milan on November 24.… read more →
Options to establish data set anonymization According to the Opinion 05/2014 on anonymization techniques,[1] two options are available to establish if the dataset is anonymised: 1. Demonstrate that, after anonymisation, it is no longer possible to: Singling out: possibility to isolate some records of an individual in the dataset;[2] Linkability:… read more →
On August 20th, EMA issued a guidance to pharmaceutical industry on anonymisation of clinical reports, in the context of phase 1 of the policy, i.e. the publication of clinical reports on the EMA website. The guidance, whose terms and indications were briefly anticipated during the EMA webinar of June 24th,… read more →
Maxer starts with this publication a series of short articles that are intended to illustrate the changes introduced by the rules on Clinical Trials Transparency and the operational implications that they produce for pharmaceutical companies. The European Medicines Agency is committed to continuously extending its approach to clinical trials data… read more →
