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Clinical Trial Services

We provide all services for conduct of successful clinical trial program or individual trial in Eastern Europe.

Provided that sponsor of a clinical trial is not based in the European Economic Area (EEA), for example, an American, Israeli or Japanese company, it is a statutory requirement to appoint a legal representative based in the EEA for the purposes of the trial.
 
FIDELIS RESEARCH clients which do not have a subsidiary within the EEA, authorize us for the purpose of performing clinical research projects as a representative, known as a “legal representative” for clinical drug trials and “authorized representative” for medical device trials.
 
Thus they fulfill the obligation that the drug and the medical device companies must be established or represented in the EU.
 
FIDELIS RESEARCH can represent you as your “legal representative” across the European Union for all your drug and medical device trials to enable submission of your regulatory applications to the European competent authorities and ethics committees.
 
FIDELIS RESEARCH can offer this service for you and your contracted local CROs who might not be able, or have sufficient experience to provide legal representation services.