Services

Areas covered include:

• Advice on legal, ethical and regulatory issues across the lifecycle of clinical development.

• Advice and best practices when working with investigators, clinical research organisations, sponsor co collaborators, vendors, ethics committees and independent review boards.

• Review, development and implementation of policies and governance frameworks.

Drafting, negotiating and advising on clinical and commercial agreements, including:

• Framework & Master Services Agreements.
• General Services Agreements.
• Indemnification Agreements.
• Confidentiality & Non Disclosure Agreements.
• Site Contracting Agreements.
• Ancillary Services Agreements.

• Outsourcing and vendor agreements.
• Data access and data-in/out arrangements.
• Intellectual Property and licensing.
• Bids & Tenders.

Acting as EU/UK legal representative for non-EU/UK life sciences companies pursuant to the Clinical Trials Regulation (EU NO 536/2014).

Establishing EU/UK legal entities for non-EU/UK life sciences companies.

Areas covered include:

• EU Clinical Trials Regulation.
• GXP
• EU GDPR and UK Data Protection.
• US Foreign Corrupt Practices Act and UK Bribery Act.
• Advice on navigating global Sanctions and Trade Laws in clinical research.
• The EU Data Act and EU Artificial Intelligence Act.

• Development and implementation of company policies, procedures and compliance programmes to support effective risk management.