How to achieve EMA policy 0070 compliance
Following on from our recent webinar on Achieving EMA policy 0070 compliance (click here to view the full recording), we’ve created a step-by-step guide to help organisations create a process to efficiently complete any data anonymisation project.
Under EMA Policy 0070, your organisation must prepare anonymised versions of clinical reports so that subjects cannot be re-identified, while retaining the data’s value for independent secondary analyses. This is not just a requirement for European organisations. In the US, the FDA is taking similar steps now too, with the launch of a new pilot initiative around clinical study reports.
We’re currently offering a free consultation with a Kinapse expert for any organisation looking to improve the way they approach clinical data anonymisation projects. To book your 1 to 1 assessment, follow the link below: