Data Protection for Life Sciences
The GDPR was enacted into European Law in 2018, following Brexit the UK adopted the UK GDPR. It imposes legal obligations on many life sciences organisations relating to how personal data is processed, transferred and managed.
The constant developments within the research, development and manufacturing of pharmaceuticals, therapeutics, biotech and medical devices have made the need for robust personal data protection practices essential.
For many research companies and clinical trial sponsors, appointing a Data Protection Officer (DPO) and a Data Protection Representative (DPR) are now fundamental legal and trial approval requirements.
This page explains what the legislation means for organisations operating in the life sciences sector and the key areas they need to consider when managing and protecting personal data.
WHAT DOES DATA PROTECTION LEGISLATION MEAN FOR LIFE SCIENCES ORGANISATIONS?
Life Sciences organisations must:
DATA PROTECTION SERVICES FOR LIFE SCIENCES ORGANISATIONS
The DPO Centre’s outsourced data protection officer service delivers flexible, tailored data protection support, advice and expertise to your life sciences organisation. The service provides you with a highly experienced data protection officer (DPO) who works on a ‘fractional’ basis as an integral member of your team.
Life sciences organisations have particular data protection needs due to the collection and processing of sensitive, special category data. Our outsourced DPOs have a broad range of experience working within the life sciences, medtech and healthcare sectors, so are able to help you to understand our data and implement an appropriate data protection framework.
Life sciences organisation that process personal data on EU or EU residents, but don’t have a physical presence within these territories are required to appoint an EU and or EU Representative to comply with Article 27 of the EU and UK GDPRs. This Representative then acts as your point of contact, assisting you to respond to data subject and regulator enquiries.
Integral to our outsourced DPO and EU and UK GDPR Representative services is access to our advice line. This service delivers month-round access to our experienced DPO team, ensuring you have the additional support and expertise required to support your team, avoid regulatory challenges and avoid delays.
IMPORTANT DATA PROTECTION CONSIDERATIONS FOR LIFE SCIENCES ORGANISATIONS
Life sciences organisations must protect personal data in a range of areas throughout their organisation and research activities. They must also be aware of multiple regulations and industry standards.
Some of the major considerations include:
Sharing data with others
Marketing and communications
Managing sensitive information
Policies and agreements
Data gathering and predicting research/clinical outcomes
BENEFITS OF OUR OUTSOURCED DATA PROTECTION SERVICE
You will benefit from the proactive support of a knowledgeable, hands-on data protection professional who undertakes all the responsibilities you would expect from a DPO and all delivered extremely cost-effectively. This expertise is then backed up by the vested knowledge within The DPO Centre’s large international team, along with the support, shared best practice and model documentation developed from the experience we have gained from working with many hundreds of clients globally, including a wide variety of life science, research organisations and medical device manufacturers.
WHO WE WORK WITH
Sponsors of Clinical Trials
Medical device companies
MedTech and Biotech
Pharmaceutical and therapeutics organisations
Clinical research organisations
WHAT OUR CLIENTS SAY
“Following the initial data mapping and construction of our RoPA in 2018, we have a good understanding of our processing activities and practical application of the legislation. The DPO Centre recently provided bespoke annual GDPR staff training as part of Venatorx’s ongoing commitment to accountability and compliance. We are confident in the knowledge that our staff understand their responsibilities and The DPO Centre’s team is on hand to assist when required.”
PCCTC Contracts Manager
“By having The DPO Centre take responsibility for the role of GDPR representative for the PCCTC we are confident we are meeting the legal requirements of the GDPR.
The DPO Centre’s team are always on hand to answer any queries we may have and to help us respond to any Data Subject Access Requests from any trial member across the EU.”
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