Shore personnel have practical experience of preparing and filing clinical trial applications across many European and ROW territories.
We can offer advice and provide practical assistance with designing clinical studies, to ensure that they will meet EU requirements.
The introduction of the Clinical Trial Directive in May 2004 has had an impact on many aspects of running clinical studies in Europe. The Directive sets out new rules for inspections, patient consent, adverse event reporting, responsibilities of Ethics Committees as well as harmonising the format of the application to both competent authorities and Ethics Committees. We can guide you through these new rules and offer advice and assistance with filing trial applications for Phase I through to Phase IV studies