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Clinical Trials Legal Services

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Legal Representation

The European Clinical Trials Regulation (Regulation (EU) No 536/2014) on clinical trials on medicinal products for human use requires that for all clinical trials carried out in the EU, a sponsor or a legal representative of the sponsor must be legally registered within the European Economic Area. Similarly, the UK also requires the appointment of a legal representative established in the UK (or the EEC) when the sponsor is not established in the UK. We offer full legal representation for sponsors not established in the EU, as required under the European Clinical Trials Regulation.

Data Protection Representative (DPR) and Data Protection Officer (DPO)

The new EU General Data Protection Regulation (GDPR) requires non-EU companies operating in the EU who control or process sensitive personal data (such as medical data of patients participating in clinical trials) to appoint an EU representative who will act as a point of contact for requests by the supervisory authorities or data subjects, and who will represent the controller or processor regarding their obligations under the GDPR. The GDPR also requires, under certain conditions, that a Data Protection Officer (DPO) be appointed and it is recommended that such a DPO be located within the EU for accessibility. It is also recommended that a DPO be appointed on a voluntary basis to better ensure compliance with EU data protection issues in general and those related to sensitive personal data and clinical trials in particular. We offer DPR and DPO-related services including the provision and advice on privacy and data protection, monitoring compliance, and acting as a contact point for supervisory authorities. Contact us today to learn more.

Investigator, site and other vendors’ contract negotiation and management

We draft, negotiate and conclude Investigator, site and other provider agreements (e.g. pharmacy, lab, etc.), based on our extensive experience. Contracts are tailored to each country’s legal requirements, business culture and activities. We constantly seek to streamline the processes in order to shorten the timelines to allow for the efficient start-up of activities. We further manage these contracts throughout the lifecycle of the study, for example where amendments or extensions are required.

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