Fortrea’s Clinical Research Unit in Leeds, UK: A Global Strategic Hub for Early Clinical Trials.

Myth 1: The MHRA are slow and miss their target review times

A: The MHRA has a strong track record in meeting their turnaround times’and publish their data each month for all to access (link below). They are consistently meeting their statutory targets, as demonstrated in the data.

We have experienced approvals as quickly as 40 days from submission for some studies. This coupled with our unique approach to study start up by compressing the time to FPI using generic screening helps us remain competitive against any region in the world.

MHRA performance data for assessment of clinical trials and established medicines

Myth 2: I need an IMPD to operate in the UK, which takes a long time and specialist know-how

A: Fortrea can help with this task. Fortrea has in-house experience within our clinical pharmacology group to write the IMPD from as little as 2 weeks from receipt of the supporting data. Typical costs vary from $15k to $35k depending on complexity

• The manufacturers’ details are required for inclusion in the IRAS form & cover letter
• Assumes 2x rounds of review from Sponsor on the IRAS form
• Early discussion with pharmacy is needed to ensure the GMP activities are well defined
• If there is any overlabelling or final batch release to be conducted at Fortrea, the Leeds CRU pharmacy needs to be included in the IMPD

Myth 3: The data I generate in the UK can’t be used for submission in other regions

A: Data generated in the UK is highly respected globally and accepted in all regions. Work conducted in the UK is easily translatable to other key countries.

Myth 4: Australia is the best location for my early clinical study

A: Australia appears to be an attractive proposition. But have you fully considered other regions? The UK has a world leading regulatory agency in the MHRA with a consistent turnaround time for reviews who are forward thinking with adaptive and hybrid clinical trials. And our facility in Leeds, UK, is arguably the best in the world right now.

To qualify for tax credits in Australia you will need to setup and register a local subsidiary, and the credits only apply to work performed by staff in the country. Often these are not sufficient to overcome the additional price against the UK.

Unlike Fortrea, the CROs in Australia are not globally integrated to progress a molecule’s development journey. We’re able to partner with you into phase II all the way to market, in all major regulatory regions, giving you critical insights along to support decision making from our TA medical teams, backed by a consistent data sciences approach to unify your data packages across studies. Data generated at Leeds is visible in near real time (10mins from collection) in our new data visualisation tools.

Myth 5: There is no price advantage to using the UK compared to the USA or Australia

A: Conduct in the UK is typically 15% cheaper than in the USA due to labour rates and study participant stipends. Based on our recent proposals we see that the UK Fortrea solution is cheaper than delivery in Australia, in some instances by up to 50% which more than negates the tax credit benefit in Australia.

And remember, to qualify for tax credits in Australia you will need to take on the extra burden of setting up and registering a local Australian subsidiary, and the credits only apply to work performed by staff in the country.

Myth 6: Following the UK’s “Brexit” from Europe, and shipping IMP into the UK is challenging

A: Since Brexit in 2019, we have never experienced an issue with the import of export of IMPs. We’ve conducted 100’s of studies in this time period, can handle quarantining via our GMP Pharmacy, and understand customs requirements intricately. We also have QP’s who can undertake these tasks and release drug for dosing in our Leeds CRU.