For any study conducted in the EU by a non-EU sponsor, there is a requirement to have a legal representative. While you can choose to appoint a different legal representative for each study, there are efficiencies of scale to having the same representative across them all.
However, if you select to use a legal representative within your CRO, having the same person across all studies is likely to be complicated. After all, you very well may use different CROs for different study programmes and it would be extremely difficult to have someone from a rival CRO acting as your legal representative. Furthermore, a CRO-based legal representative might struggle to provide independent advice.
Do you need to, or can you, have a different legal representative for each trial?
One of the main roles of the legal representative is to help the sponsor ensure their compliance with the regulation. It therefore makes sense to have somebody who knows you, knows your business, your quality systems, and your routine.
A good legal representative will check your quality system and speak with your quality manager, regulatory teams and project management team to ensure you are in compliance. This brings both greater efficiency and reduced cost, since there will be less repetition of your compliance and quality checks.
How much does the legal representative service cost?
A cost proposal for a legal representative isn’t that straightforward since it will depend on a number of factors. However, having specialised in acting as a legal representative for many years, we have an excellent understanding of the workload involved.
Typically, costing will start with a pre-assessment process to determine any quality and compliance issues that the sponsor might have. Under the Clinical Trial Regulation, the legal representative must put their name to a signed document stating they vouch to “ensure” – the term ensure now in the CTR lexicon – that a non-EU sponsor will be compliant with the EU regulation. To do so, they must understand the sponsor’s quality systems and that these are robust.
The cost of the service, therefore, will depend on the workload involved in preparing the sponsor and their quality system for EU compliance. Companies that have conducted clinical trials in Europe before are more likely to have a good understanding of the regulatory requirements and good systems in place to manage their trial and vendors. Those new to the market may need more time and assistance to get everything in good shape and at a point where their legal representative is happy to sign those documents so studies can begin.
Factors influencing cost
So, the costs can vary depending on the assessment and additional activities needed to get the sponsor ready.
Other factors that will influence volume of work, and therefore the cost, include:
- The size of the study
- The phase of the study
- The protocol
- The number of countries involved
The type of product also needs to be considered, because sponsors require a legal representative for both medicinal products and medical devices. In fact, under the Medical Device Regulation and In Vitro Diagnostic Regulation, wording for the role and responsibility of the legal representative is almost identical to that for medicinal product.
All these factors need to be considered first before cost can be determined.
Only once this assessment has been carried out and any QMS issues have been addressed can IDEA Regulatory take on the responsibility of acting as legal representative.
“Having specialised in acting as a legal representative for many years, we have an excellent understanding of the workload involved”