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Clinical Trials Legal Services

Clinical Trial Legal Services

EU & UK Clinical Trials Legal Representation & GDPR Services

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 start-up 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.
Tailored, country specific contracts informed by extensive multinational experience.

Who Is This Service For

Non-EU Sponsors

Who must appoint an EU legal representative to run clinical trials in the EU.

Non-UK Sponsors

Conducting trials in the UK who require a UK established representative.

Biotech and Pharma Organisations

Managing multicounty clinical programmes requiring tailored, compliant contracts.

Companies Handling Patient Data

Requiring GDPR DPR or DPO support to meet regulatory obligations

Working With hVIVO

Regulatory Assessment & Representative Appointment

We determine sponsor obligations and act as your EU/EEA or UK legal representative as required.

GDPR Compliance & Data Protection Setup

We provide DPR/DPO services, advise on privacy compliance, and serve as supervisory authority contact points.

Contract Drafting & Localisation

Contracts for investigators, sites, pharmacies, labs, and other vendors are drafted and customised to each country's legal environment and operational culture.

Negotiation & Streamlined Start-Up

We negotiate contracts across territories, shortening timelines and reducing barriers to study initiation.

Lifecycle Contract Management

Amendments, extensions, and administrative updates are managed throughout the full course of the clinical trial.

Case Study

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.

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Efficient start-up enabled through contract streamlining.

Successful multicounty negotiations tailored to local requirements.
Based on described responsibilities and outcomes.

Why Choose hVIVO

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 world class infectious disease expertise.

What this means for you:

25+ years of life sciences regulatory and contracting experience.
Integrated expertise spanning consultancy, clinical operations, and lab services.
Proven ability to accelerate study startup through efficient contract and legal management.
Backed by hVIVO’s extensive clinical infrastructure and scientific leadership.

FAQ

Do non-UK sponsors need a UK representative?

Yes. UK law requires a UK established legal representative for any sponsor located outside the UK.

When is a DPR or DPO required?

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

Can you manage all study related contracts?

Yes. We draft, negotiate, and manage all site, investigator, and vendor contracts throughout the study lifecycle.