As with all aspects of GDPR compliance, any system, process or infrastructure that uses personal data must be created and designed from the beginning by identifying possible risks to the rights and freedoms of the data subjects and minimising them before they can cause actual damage – privacy by design. GDPR data requirements on closing a clinical trial are no exception.
Clinical Trial GDPR Compliance: Key GDPR considerations often overlooked by non-EEA clinical trial sponsors
When learning anything new, something will inevitably be forgotten or overlooked. And implementing the GDPR for the first time is no exception, especially when we can only draw upon other data protection and data privacy laws with very different compliance requirements. This is where a GDPR compliance consultancy can keep you on track, ensuring nothing slips through the net.
The EEA and UK continue to pack a punch in the clinical trial arena – but what does this mean for sponsors from a data protection perspective?
Choosing the right country or countries, sites and investigators for a clinical trial is critical for success in any pharmaceutical drug or medical device development programme.
Biopharmaceutical small- and medium-sized enterprises (SMEs) running clinical trials in the EEA must comply with the GDPR like larger companies performing similar data processing activities. However, you may not have the in-house expertise and need to outsource. Hiring the right GDPR compliance consultancy can be challenging, but when successful can save you time, money and stress.
Challenges of GDPR compliance for clinical trials spanning multiple international borders – a case study
Clinical trials often occur cross-border, involving sites under different regulatory authorities across multiple countries and continents. In our experience, it can be challenging to understand and comply with the data protection and privacy requirements for clinical trials. There are often differences in local laws and their interpretation relating to the interplay between these regulations and those specific to clinical trials.
An overview of data mapping, describes data mapping in the context of the GDPR, outlines the basic steps, and explores why you should view an up-to-date data map as a benefit to your company rather than a time-consuming headache.
This article explains when to conduct a DPIA, provides an overview of the steps undertaken during a DPIA and how a GDPR compliance consultancy can support you through the process.
This article explores at a high level the similarities and differences between the principles underlying the processing and protection of personal data under the GDPR and HIPAA.
In Europe, the General Data Protection Regulation (GDPR) is the gold standard for protecting the privacy of all EU individuals across all industries and sectors, both public and private organisations. For this reason, understanding how the GDPR applies to pharma data-processing activities can be confusing, making compliance challenging, especially when your clinical research crosses international borders.