Our fees are based on the level of service provided making them flexible according to your needs.
The costs involved for legal representation as a standalone service vary depending on the clinical phase, number of subjects, participating countries, investigational product and its indication. The costs will directly reflect the time we will need to spend in order to fulfil our duties as your legal representative. Fees for legal representation are usually charged per study (protocol).
There is a one off set-up fee to cover the cost of our safety/risk analysis of the trial. This is charged on signature of the work order.
A monthly maintenance fee is charged from the month in which the first CTA/EC submission is made in the EU, until the month of submission of the final end of trial declaration submission in the EU. A smaller retention fee is then billed until the Clinical Study Report Summary is submitted to the authorities and our official duty as Legal Representative ends.
As legal representative, IDEA Regulatory takes on legal responsibility for the GCP, regulatory and ethical compliance of the trial in the EU. The maintenance fee covers our liability for this, our running costs and also includes the various tasks carried out by IDEA Regulatory in the role of Legal Representative (e.g. co-signing investigator contracts and power of attorneys, deadline reminders, and compliance advice). We do not bill our time additionally for tasks within this scope allowing you to easily manage your budget.