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.
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.
For US and other non-EU pharmaceutical or biotech companies launching clinical trials in Europe, GDPR compliance could be seen as another data protection hoop to jump through. However, apart from the legal obligation and avoidance of significant financial penalties and sanctions, GDPR compliance can make your business more efficient, secure and competitive.
Records and documentation of data processing activities, sharing and retention are mandatory under GDPR. What does this mean for pharmaceutical clinical trials in Europe?
This article provides an overview of your responsibilities under the GDPR, and a brief description of the mandatory documents required to fulfil data protection regulatory obligations.
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.
If a pharmaceutical company complies with the EU Clinical Trials Regulation, do they automatically comply with the GDPR?
A brief overview of the European Union (EU) Clinical Trials Regulation, some examples of how the GDPR and CTR interrelate and how working with a pharma GDPR consultancy can help you comply with both regulations.
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.