Helping the pharmaceutical industry safeguard data subjects’ privacy and ensure compliance with EU and UK GDPR
Data Protection Services by Pharma Data Protection
Working with you to find the best solutions to your GDPR compliance needs.
Data Protection Officer
The Data Protection Officer (DPO) role is mandatory for pharma/ biotech companies that process health-related personal data. Our comprehensive DPO service at Pharma Data Protection gives you the peace of mind that your data protection and regulatory requirements are in reliable, experienced hands. We draw on best practice from our client base to provide objective, independent advice and an extra layer of accountability and support to your organisation.
Are you a pharmaceutical/biotech SME finding it challenging to deliver on your DPO responsibilities? Our specialist team understands pharma and how to apply the GDPR to your working practices.
Find out more about the benefits of our Data Protection Officer as a Service.
Data Privacy Training
Data protection and data privacy training are mandatory under GDPR. Responsible organisations train their management and clinical teams in data privacy and protection, empowering them to play their part, becoming the eyes and ears of data security, thus mitigating the risk of a breach.
Do you have the in-house resources and expertise to deliver data protection/privacy training?
Our specialist team has extensive European pharmaceutical data protection and privacy knowledge and experience. Our training helps your teams navigate the legal intricacies and apply them to pharma and biotech working practices.
Find out more about our Data Privacy Training Services.
Data Protection Impact Assessment
A Data Protection Impact Assessment (DPIA) is required under the GDPR any time you begin a new project that involves a high risk to other people’s personal information and is mandatory for companies that process special category/sensitive data (e.g., health data).
The GDPR provides no specific guidance on completing a pharmaceutical data protection impact assessment for clinical trials, making it an often daunting process, particularly for those new to GDPR compliance.
Undertaking a DPIA is a routine task for us at Pharma Data Protection. We have developed comprehensive screening checklists based on years of experience applying the GDPR to pharma industry working practices.
Find out more about our DPIA Data Protection Impact Assessment services.
Data mapping is a system of cataloguing the data you collect, process, store and share, i.e., your data inventory and data flow and is an essential compliance measure for companies worldwide bound by data privacy laws, including the GDPR.
With a comprehensive data map, your compliance teams can implement a successful privacy plan, answer data access requests, swiftly supply information for breach investigations and safeguard data in cross-border transfers.
Our pharmaceutical GDPR compliance team can help you identify and categorise the data you process and support you in streamlining your records and processes, moving you towards GDPR compliance.
Find out more about our Data Mapping Services.
Handling mandatory documentation can sometimes be challenging, even when you know what you're doing. However, creating, updating or reviewing data protection documentation is impossible when you have finite resources and limited GDPR knowledge or experience.
Are you a pharmaceutical product or biotech medical device research organisation that needs some support to prepare GDPR-compliant documentation?
Our data protection specialists live and breathe GDPR regulatory documentation. They pragmatically apply the legislation to ensure your documents are industry-specific and demonstrate GDPR compliance.
Find out more about our Mandatory Documentation services.
International clinical trials mean that cross-border data transfers are now commonplace. However, the additional steps required to transfer data under EU/UK data protection law, including complex Transfer Impact Assessments (TIAs) and the confusion around suitable transfer tools, can lead research projects to be delayed or cancelled.
Is your pharma research organisation planning a clinical trial in Europe? Are you finding the changing landscape of cross-border data transfers challenging?
Our experienced team can provide up-to-date information and advice on GDPR-compliant cross-border transfers and the Standard Contractual Clauses.
Find out more about our Cross-border Transfer services.
Ad hoc Regulatory Support
Keeping abreast of the regulatory requirements for clinical trials in Europe, alongside the challenge of understanding the GDPR in the context of your pharma working practices and international cross-border data transfers, can be overwhelming, especially if you don't have the in-house resources or expertise.
We offer accessible and affordable ad hoc regulatory support for pharma/biotech companies that need extra help with EU/UK data protection now and again.
We share our tools, assistance, and expertise to help you safeguard data subjects' privacy and ensure maximum regulatory compliance.
Find out more about our Ad hoc Regulatory Support.
Technical and Organisational Measures (TOM)
To achieve GDPR compliance, your organisation must demonstrate that you have appropriate Technical and Organisational Measures to safeguard and secure the personal information you collect, process and store.
The GDPR does not detail the TOMs you should use, as they must be appropriate for the nature of your business and data processing activities, as well as the risks to data subjects.
Our data protection compliance consultants can help you identify and review your current Technical and Organisational Measures. We understand pharma working practices and thus can recommend appropriate improvements to mitigate risk and ensure you can demonstrate compliance with the GDPR.
Find out more about our Technical and Organisational Measures.
we understand pharma and data protection
Learn more about how EU and UK data protection legislation affects your European clinical trials.