Clinical Trial Authorisation
Clinical Trial Application (CTA) is the first stage of the drug license process. The European Clinical Trials Directive requires that any medicinal products/drugs in Phase I - IV of development must undergo a clinical trial. Clinical Trial Applications must be submitted to the appropriate Member State and approval must be granted before the study can commence.
TRAC can provide support with the regulatory requirements of a clinical trial application; providing guidance and practical services with the preparation of the application, handling the submission process and liaising with regulatory bodies to obtain clinical trial authorisation.
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 clinical trial application. 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.
The TRAC team has extensive regulatory knowledge and experience coordinating clinical trial applications and amendments to clinical trial application. Contact us today for advice and guidance to ensure you effectively meet your regulatory requirements.