Data protection for life sciences and pharma
Pharmaceutical organisations sit at the intersection of innovation, regulation, and highly sensitive personal data. From early-stage research to post-market surveillance, data flows through a network of stakeholders, including sponsors, clinical sites, contract research organisations (CROs), and regulatory authorities. These data exchanges frequently span multiple jurisdictions, each with distinct legal, ethical, and compliance requirements, adding further complexity to how information is managed, protected, and used.
We’ll guide you through this web.
Life sciences data is not like any other.
You do not need us to tell you that health data, genetic profiles, and clinical trial results carry weight. Or that your data rarely sits with a single entity; it moves between sponsors, CROs, sites, vendors, and regulators, across borders and legal frameworks that do not always speak the same language.
What we offer is a team that understands that ecosystem from the inside and knows how to build privacy frameworks that hold up within it.
Where we typically come in
-
Role confusion across the chain.
Controller, processor, joint controller… in multi-party setups, these distinctions are rarely straightforward. We help map responsibilities clearly, so contracts reflect reality and oversight does not fall through the cracks.
-
The pseudonymisation grey zone.
In most cases, clinical data is pseudonymised, not anonymised. It is still personal data, and it still needs to be treated as such. We help you embed that understanding operationally, not just on paper.
-
Competing regulatory obligations.
Long-term retention requirements, such as up to twenty-five years under the Clinical Trials Regulation (CTR). Data minimisation and storage limitation under the GDPR. These do not always point in the same direction, and the right answer depends on the specific context. We help you find it.
-
Cross-border studies and transfers.
Global research means global data flows. We ensure your transfer mechanisms are sound, and your approach is consistent across jurisdictions, without grinding operations to a halt.
-
Secondary use questions.
Reusing data from a previous study for a new one? This is often possible, but it depends on purpose, transparency, and where you are operating. We help you assess it quickly and correctly.
What working with us looks like.
Our support adapts to where you are in your programme. Whether you need hands-on help with study-specific (such as informed consent forms and clinical trial agreements), a DPIA for a new study or other project, a data sharing framework across complex structures (e.g. sample sharing, patient registries), or alignment between GDPR and sector-specific requirements like GCP, GVP, CTR, IVDR or MDR, we work as an extension of your team, not a distant advisory function.
One consultant leads your project. A broader team of specialists sits behind them. You get responsiveness and depth, without having to choose between the two.
When life sciences companies come to us.
A new trial launching. An international expansion. A merger bringing two compliance frameworks together. An audit flagging gaps in vendor oversight and incident management. A research initiative that raises secondary use questions.
The trigger varies. The underlying need is the same: a partner who understands life sciences, moves at the pace of your operations, and gives you answers you can act on.
Meet our Life Science specialists
Bastien de Marchi
Helena Peten de Pina Prata
Manon Darms
Frequently asked questions
Do you have experience with our type of organisation (sponsor / CRO / medtech)?
Yes. We work with a range of life sciences organisations, including pharmaceutical companies, contract research organisations (CROs), and medical device manufacturers. Our consultants understand the different roles these organisations play in the data ecosystem and tailor their support accordingly.
Are your consultants familiar with sector-specific regulations like CTR, MDR, IVDR, GCP, GVP, or only with GDPR?
We already have an internal DPO. Can you work alongside them rather than replacing them?
Can you support us on a single project, or do you only work on full privacy programmes?
We are based outside Belgium. Can you still support us?
We work across multiple countries. Can you ensure consistency across jurisdictions?
How quickly can you get started on an urgent matter?
Can you help us with sector-specific documents like Informed Consent Forms?
Do you conduct DPIAs for clinical studies, patient registries, and other research projects?
Can you review or draft our agreements with CROs and other partners?
Interested in our privacy solutions for life sciences?
Get in touch. Fill in the form below and we will get back to you within two working days. For urgent queries, reach us on 02 310 39 63.
