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What to look for when outsourcing to a GDPR compliance consultancy
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.
Continue Reading...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.
Continue Reading...Business Benefits of Data Protection and Data Privacy in Clinical Trials in Europe
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.
Continue Reading...The Role and Responsibilities of the GDPR Data Protection Officer
The EU GDPR and UK GDPR require organisations to appoint a Data Protection Officer (DPO) if their data processing activities meet specific criteria. The DPO is mandatory for pharma or biotech companies processing health-related information on data subjects in the EU or UK. The DPO’s role and responsibilities are distinct from those of the Data Protection Representative (for companies not established in the EU or UK). The role should not be confused with other roles, such as the legal representative under the Clinical Trials Regulation.
Continue Reading...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.
Continue Reading...Outsourcing Data Protection. A biotech client’s perspective
The GDPR’s widespread effects touch almost every clinical research, biotech and pharmaceutical business – no matter where they are based or what type of work they are doing.
Here we share with you an interview with one of our US clients, describing their engagement with the GDPR and how outsourcing data protection was the best way for them to solve their security, privacy, and compliance challenges.
Data Protection and Data Privacy Training are Mandatory under GDPR
This article discusses what the regulations say about data protection and privacy training, who should receive training and the benefits to your organisation of raising awareness among your staff.
Continue Reading...What is Data Mapping, and why is it essential to GDPR compliance?
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.
Continue Reading...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.
Continue Reading...What is a Data Protection Impact Assessment, and why is it a requirement of GDPR?
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.
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