Clinical Trial Applications

Preparation, Submission and Approval

Our specialist team has extensive knowledge and experience in the preparation, submission and approval processes for Clinical Trial Applications (CTA) in Europe.

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.

Our team of dedicated experts continually remains at the forefront of regulatory affairs legislation. This ensures that we can accurately complete the required application forms and provide information and guidance for you throughout this process.

If you have any further questions regarding Clinical Trial Applications please Contact Us or complete and submit an Enquiry Form.

Substantial Amendments to Clinical Trial Applications

Substantial amendments are changes to approved clinical trials which are likely to have a significant impact on:

• The safety or physical or mental integrity of the subjects,
• The scientific value of the trial,
• The conduct or management of the trial; or
• The quality or safety of any IMP used in the trial.

These amendments may arise from changes to the protocol or new information concerning the scientific documentation which is supporting the trial. Different approaches will be required depending on the nature of the amendment, competent authority (CA) and ethics committee.

TRAC can:

• Suggest the type of amendment necessary.
• Produce a list of all supporting information necessary.

• Provide information on the requirements of individual CAs.
• Complete the notification of amendment form.
• Update supporting information and protocol where necessary.
• Update the EudraCT form.

TRAC has extensive experience in preparing substantial amendments to clinical trial applications and can undertake your project with efficiency and confidence.