Trac Services | Clinical Trial Applications |TRAC Services
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Clinical Trial Applications

The consultancy for global, pharmaceutical regulatory affairs

The TRAC team is with you every step of the way. With our support and advice you can be confident of meeting your regulatory requirements right from the start.

We cover all aspects of a clinical trial application, including:

  • guidance and practical assistance with the preparation of the application
  • handling of the submission process
  • liaising with regulatory bodies to obtain clinical trial authorisation
  • dealing with all substantial and non-substantial amendments

 

Read our industry paper to find out more aboutĀ UK Clinical Trial Applications

CLINICAL TRIAL AUTHORISATION

A Clinical Trial Application (CTA) is the first stage of the drug licence process. The European Clinical Trials Directive requires that any medicinal products/drugs in Phase I – IV of development must undergo a clinical trial. CTAs must be submitted to the appropriate Member State and approval must be granted before the study can commence.

 

CTA SUBSTANTIAL AMENDMENTS

During the course of a clinical trial it may be necessary to make changes to the protocol or to supporting documents as part of the CTA. Changes are categorised as substantial and non-substantial amendments.

Substantial amendments are likely to have significant impact on the safety, physical or mental integrity of the subjects, or the scientific value of the clinical trial and require an application for a substantial amendment to the relevant regulatory agency.

We hope our reputation and website inspire you to get in touch!