We provide full legal representation for clinical trial sponsors operating in the EU or UK, alongside GDPR compliant data protection services and comprehensive contract drafting, negotiation, and management to streamline trial startup and ensure regulatory compliance. Essential for sponsors who operate within the UK or EU.
EU & UK legal representation for non-EU/EEA sponsors, fully aligned with Regulation (EU) No 536/2014.
GDPR compliant Data Protection Representative (DPR) and Data Protection Officer (DPO) services.
Full drafting, negotiation, execution, and lifecycle management of site, investigator, pharmacy, lab, and vendor contracts.
Contact us for compliant EU/UK representation and streamlined trial startup.
Support for sponsors not legally established in the EU/EEA or the UK, ensuring full compliance with the EU Clinical Trials Regulation and UK requirements.
For non-EU companies controlling or processing sensitive clinical trial data, we act as your DPR or DPO, handling supervisory authority interactions and monitoring compliance.
Drafting, negotiating, and executing agreements with investigators, sites, labs, pharmacies, and other providers, tailored to legal and cultural norms of each country. Ongoing contract lifecycle management is also provided.
We determine sponsor obligations and act as your EU/EEA or UK legal representative as required.
We provide DPR/DPO services, advise on privacy compliance, and serve as supervisory authority contact points.
Contracts for investigators, sites, pharmacies, labs, and other vendors are drafted and customised to each country's legal environment and operational culture.
We negotiate contracts across territories, shortening timelines and reducing barriers to study initiation.
Amendments, extensions, and administrative updates are managed throughout the full course of the clinical trial.
Regulatory Representation
Data Protection & GDPR Compliance
Contracting Excellence
Operational Efficiency
hVIVO consulting brings decades of clinical, regulatory and operational experience, supported by the broader hVIVO group, which includes end-to-end drug development capabilities, specialist clinical trial execution, and worldclass infectious disease expertise.
What this means for you:
Our clinical trial legal services have supported diverse global sponsors entering the EU and UK markets, enabling them to meet regulatory obligations, secure rapid approvals, and establish operationally efficient study infrastructures.
Examples include:
Efficient startup enabled through contract streamlining.
Successful multicounty negotiations tailored to local requirements.
Based on described responsibilities and outcomes.
Yes. EU Regulation 536/2014 requires a legally established EU representative for all clinical trials.
Yes. UK law requires a UK established legal representative for any sponsor located outside the UK.
Non-EU companies handling sensitive personal data (such as clinical trial data) must appoint a DPR, and in many cases a DPO is recommended or required for GDPR compliance
Yes. We draft, negotiate, and manage all site, investigator, and vendor contracts throughout the study lifecycle.
Sign up to our emails and follow us on social media to keep up to date with hVIVO.
