Who We Are

Hemex is a European Contract Research Organization (CRO) supporting pharmaceutical, biotech, and medtech SMEs with comprehensive clinical development solutions. Headquartered in the Basel region, with offices in Germany, Benelux, and across three continents, Hemex specializes in multinational clinical trials. Services include clinical operations, regulatory support, quality assurance, BA/BE, PK, and Phase I-IV studies, rapid patient recruitment, and imaging core lab services. Hemex also provides strategic guidance in securing European and Swiss non-dilutive funding.

HEMEX in SEARCH

Within the SEARCH project, HEMEX plays a central role in ensuring that synthetic data innovations are aligned with regulatory, ethical, and compliance standards.

• We lead activities related to regulatory compliance requirements.
• We act as the main interface with regulatory agencies and health technology assessment (HTA) bodies such as the EMA, FDA, and EUnetHTA.
• We contribute to the Steering Committee by taking on the roles of Data Manager and Compliance Manager, ensuring adherence to GDPR, FAIR data principles, and the highest ethical standards.
• In collaboration with hospitals and clinical partners, we support the curation of high-quality datasets while evaluating the real-world applicability of synthetic data models.

From Compliance to Real-World Impact

Our contribution to SEARCH goes beyond regulatory oversight.

• We help shape recommendations and guidelines for stakeholders across the healthcare value chain, paving the way for the adoption of synthetic data technologies in clinical practice, policy, and industry.
• By co-leading dissemination and outreach activities, we raise awareness among start-ups, healthcare companies, and industry stakeholders, ensuring that results can be translated into tangible, market-ready solutions.
• We also contribute by embedding social sciences and humanities (SSH) perspectives into SEARCH. This ensures that advances are scientifically rigorous, socially responsible, and aligned with patient needs.

Why It Matters

Synthetic healthcare data has the potential to transform research and clinical practice. It can overcome:

• Data scarcity
• Privacy restrictions
• Interoperability barriers

Researchers and healthcare professionals often face difficulties in accessing and sharing real-world datasets due to strict data protection regulations, leading to lost insights. Synthetic data preserves privacy while enabling the development of powerful AI and machine learning tools.

However, the potential of synthetic data cannot be fully realized without strong compliance frameworks and a clear path to regulatory approval.

This is where HEMEX brings unique value:

• We bridge the gap between disruptive innovation and regulatory acceptance.
• We create the foundation of trust needed for adoption.
• We ensure datasets meet strict legal and ethical standards and can be safely integrated into real-world healthcare systems.

Our involvement strengthens the translation of scientific innovation into societal benefit, supporting novel therapies, diagnostic tools, and creating opportunities for inclusive and impactful healthcare across Europe.

Looking Ahead

For HEMEX, being part of SEARCH is more than participation in a European project—it is an opportunity to help shape the future of healthcare data governance.

Together with our consortium partners, we are laying the groundwork for a new era where synthetic data enables secure, scalable, and collaborative research across borders.

Looking ahead, we see SEARCH as a catalyst for:

• Building trust in synthetic data.
• Fostering collaboration between academia, industry, and regulators.
• Ensuring innovations are delivered responsibly to patients.

By combining regulatory excellence with innovation management, HEMEX ensures that disruptive ideas can become real-world solutions.

At HEMEX, our vision remains clear: to accelerate innovation, build trust, and deliver better healthcare for patients across Europe and beyond.