EU Legal Representation Services

We Understand Your EU Legal Challenges:

  • Does your company currently not have an office in the EU?
  • Would you like to run a study or part of a study in the EU?
  • Is your CRO aware of statutes and regulations in the EU?
  • Does your CRO stay up-to-date with EMA updates to requirements and obligations?

Complying With Directives and Regulations Released by the European Medicines Agency (EMA)

The European Clinical Trials Directive (2001/20/EC) indicates that a Sponsor wishing to conduct a clinical trial in the European Union must either have a registered office within the European Economic Area (EEA) or work with a legal representative with an established office within the EEA community.

With an office in Amsterdam that specializes in complying with regulations released by the EMA, ARG is an ideal choice to serve as your Legal Representative in Europe. A full-service CRO, ARG combines comprehensive global solutions equivalent to the largest of our competitors, along with individualized customer service. With the advent of the UK leaving the EU on 1st January 2021, the UK will accept a Legal Representative based within the EEA and mirror the requirements of the European Clinical Trials Directive, for studies taking place within the EU. 

If a study is to take place in the UK alone sponsors will need to nominate a separate UK-based ‘Legal Contact’ in the UK and ARG are able to provide this service from our London office. 

“Ever since I started in clinical research I have enjoyed the daily challenges and new discoveries."
“ARG’s history and experience in running clinical trials will be of great benefit in assisting our EU Legal Representation Service activities, allowing us to extend our customer-focused ideology and work efficiencies to ensure our sponsors' studies will be in full compliance of all regulatory requirements.”
Ignazio Di Giovanna, VP, Europe

Main EU Legal Offerings

  • Help sponsors understand the regulatory requirements
  • Put together a customized solution to ensure compliance
  • Stay up-to-date on and communicate EU legal requirements
  • Assist in coordinating site inspections to comply with the International Conference of Harmonisation (ICH) and Good Clinical Practice (GCP)
  • Prepare clinical trial authorisations and amendment submissions by working with the relevant Ethics Committees and National Competent Authorities

Responsibilities

The Legal Respresentative

  • Help sponsors understand the regulatory requirements
  • Put together a customized solution to ensure compliance
  • Stay up-to-date on and communicate EU legal requirements
  • Assist in coordinating site inspections to comply with the International Conference of Harmonisation (ICH) and Good Clinical Practice (GCP)
  • Prepare clinical trial authorisations and amendment submissions by working with the relevant Ethics Committees and National Competent Authorities
Process
  • Only one Legal Representative may be appointed by the Sponsor for a specific protocol
  • The Legal Representative may be located in any EEA Member State, regardless of the Member State(s) in which the protocol is conducted
  • A Letter of Authorisation must be prepared on the Sponsor’s headed paper, which includes acknowledgement by the Legal Representative of the role
  • The Letter of Authorisation must be included in each initial application to a Competent Authority or Ethics Committee regarding the protocol
  • The Sponsor may appoint different Legal Representatives for different protocols
  • For UK-only studies, a UK-based Legal Contact needs to be nominated

USE CASE

ARG MAINTAINS

Standards and Regulations with Ability, Personnel and Knowledge

The CHALLENGE

As regulations inevitably change, there are always a few legal aspects to studies where a sponsor finds themselves asking questions such as “Did the governing body really mean that?” or “What are we supposed to do to remain compliant?” The underlying challenge in this dynamic landscape, beyond answering any one particular question, is to work with legal representation that is continually in the know. 

Further, the EU legal representative will have to provide quality assurance oversight across the full extent of the trial. Since this often includes aspects conducted not only in the EU but also those potentially conducted outside the EU but linked to the trial, finding the right partner is compulsory for the compliance of the trial.

The SOLUTION

The ARG solution is to provide an individualized solution based on expertise and experience. By gathering key facts together, such as phase of study, therapeutic area, countries, number of sites, and the length of trial, we are able to provide representation suited to the precise needs of the sponsor and the study.

Beyond that, ARG seeks to build a structure that can be maintained throughout the cycle of the partnership, focusing on next-level considerations, such as explaining the legal implications of managing a single project vs. a multi-step program, then planning and executing the best way forward.

MOVING FORWard

ARG has the ability, personnel and knowledge to ensure clinical trials are run to the applicable standards and regulations. Along with our professional legal services, each part of the project is cared for with individual attention. 

With over 20 years experience of running clinical trials in Europe, sponsors can rest assured we have the process in place to ensure compliance and oversight of their trials.