European regulatory data framework for data sharing and reuse in life sciences and healthcare
We specialize in the European regulatory data framework that shapes how data is shared and reused in the life sciences and healthcare sectors.
Our expertise spans the key pillars of EU regulation: including the newly adopted European Health Data Space (EHDS) Regulation and the AI Act, as well as foundational frameworks like the General Data Protection Regulation (GDPR) and the Data Governance Act (DGA).
These regulations, in addition to legal provisions, also enshrine principles of data governance and technical requirements.
As an innovator, healthcare institution, healthcare professional, clinical data manager, or part of a hospital’s IT, administrative, or leadership team, you need clear answers to key questions:
Our expertise spans the key pillars of EU regulation: including the newly adopted European Health Data Space (EHDS) Regulation and the AI Act, as well as foundational frameworks like the General Data Protection Regulation (GDPR) and the Data Governance Act (DGA).
These regulations, in addition to legal provisions, also enshrine principles of data governance and technical requirements.
As an innovator, healthcare institution, healthcare professional, clinical data manager, or part of a hospital’s IT, administrative, or leadership team, you need clear answers to key questions:
What are your responsibilities and obligations under the evolving EU regulatory data framework?
What are the risks and consequences of non-compliance?
What should you start preparing today?
We help you make sense of this evolving landscape, ensuring that your data practices are compliant, future-ready, and trusted.
We help you build solid data governance aligned with EU DATA REGULATORY requirements and the SCIENTIFIC and OPERATIONAL demands specific to healthcare and life sciences.
We help you build solid data governance aligned with EU DATA REGULATORY requirements and the SCIENTIFIC and OPERATIONAL demands specific to healthcare and life sciences.
EDUCATION
Trainings and workshops tailored to your real-world challenges.
CONSULTANCY
Regulatory and operational requirements of European data regulatory framework.
OPERATIONAL SUPPORT
Design processes and flow for an efficient data governance and data sharing.
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What we do
We help you develop a holistic data strategy, tailored to your organization’s goals, capacity, and context: financial, operational, and logistical.
• We help to establish efficient data governance, essential for internal data sharing and reuse, as well as for external collaborations.
• We build-up processes and procedures tailored to your organization, activity or project.
• We train your staff, helping them understand their roles and build documented knowledge- as required by regulators.
• We build-up processes and procedures tailored to your organization, activity or project.
• We train your staff, helping them understand their roles and build documented knowledge- as required by regulators.
Why it works for you
Our promise: HUMAN-FIRST, QUALITY-focused, MISSION-driven.
• Human-centered approach. Because no strategy works without people.
• Quality is non-negotiable. Whether it's your processes, your data, or your decision-making — you need solid ground, not shortcuts.
• Everything is tailored. No copy-paste templates. Just solutions that truly fit your context, your risks, your stage.
• We work with respect- for your mission, your people, and your pace.
• Quality is non-negotiable. Whether it's your processes, your data, or your decision-making — you need solid ground, not shortcuts.
• Everything is tailored. No copy-paste templates. Just solutions that truly fit your context, your risks, your stage.
• We work with respect- for your mission, your people, and your pace.
What changes for you
Data governance is not a back-office task, it is a strategic enabler. And when it is done right, it gives you the freedom to move forward with CLARITY, CONFIDENCE, and INTEGRITY.
• You get a clear map of your risks, needs, and action points.
• Your processes are fit for purpose and aligned with today’s fast-moving compliance environment.
• Your teams know what to do — and more importantly, why.
• Your processes gain structure.
• Your stakeholders gain trust.
• Your processes are fit for purpose and aligned with today’s fast-moving compliance environment.
• Your teams know what to do — and more importantly, why.
• Your processes gain structure.
• Your stakeholders gain trust.
The advantage to collaborate with us
TIME & BUDGET
• Avoid the cost of hiring a full-time in-house expert;
• Scale the service on-demand (project-based, part-time, fractional);
• Reduce costs linked to compliance mistakes, breaches, or penalties.
EXPERTISE
• Gain up-to-date knowledge and sector-specific experience;
• Apply best practices learned across the field;
• Tailored knowledge sessions to upskill your team.
INDEPENDENCE & OBJECTIVITY
• Get an unbiased view of internal data practices and risks;
• Detect blind spots that internal teams might overlook;
• Enhances transparency and credibility.
• Avoid the cost of hiring a full-time in-house expert;
• Scale the service on-demand (project-based, part-time, fractional);
• Reduce costs linked to compliance mistakes, breaches, or penalties.
EXPERTISE
• Gain up-to-date knowledge and sector-specific experience;
• Apply best practices learned across the field;
• Tailored knowledge sessions to upskill your team.
INDEPENDENCE & OBJECTIVITY
• Get an unbiased view of internal data practices and risks;
• Detect blind spots that internal teams might overlook;
• Enhances transparency and credibility.
Give Your Data a Chance to Create Value - Securely and Responsibly
Contact us!
Partner with us, collaborate on innovative projects, or take advantage of our traineeship opportunities. Let’s grow and make an impact together!
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