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Clinical Trial Application

Legislation

Clinical trials are investigations in humans intended to discover or verify the effects of one or more Investigational Medicinal Products (IMPs). Requirements for the conduct of clinical trials in the EU are provided for in the Clinical Trials Directive Directive 2001/20/EC(1)which requires that any medicinal products/drugs in Phase I - IV of development must undergo a clinical trial.

Prior to the start of a clinical trial anywhere in the EU, a Clinical Trial Application (CTA) must be submitted to the appropriate Member State and approval granted before your study can commence.

Although the Clinical Trials Directive has gone some way to harmonising the rules for the approval of an EU clinical trial, there are often issues with regards to some Member States requiring additional data, timeline adherence and differences of opinion on the adequacy of CTA data.

CambReg’s CTA services

We can help you by:

  • Preparing, submitting and co-ordinating your CTA activities
  • Reviewing your CTA submission documentation (‘gap analysis’)
  • Authoring your IMP Dossier (IMPD)
  • Maintaining your CTA (substantial amendments, end of trial declarations etc)

Our experience can benefit you

We at CambReg are proud to boast that Dr Mike James (our Technical Director) is an ex MHRA assessor of clinical trial applications. During his time at the UK Health Authority, Dr James assessed over 2,000 applications including over 400 for biotech products. Using his unique expertise and experience we can compile assessor friendly applications.

In addition, we have an international network of tried and tested regulatory associates who can prepare and submit or advise you on your clinical trial applications worldwide.

 

References

  1. http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:en:PDF