CLINICAL STUDY SET-UP

On April 1st 2016, the new Health Research Authority (HRA) clinical research governance system was fully implemented in the UK. All UK clinical studies must now follow this process.

The founders of TCRS played a key role in developing the HRA system, and have an in-depth understanding of the harmonisation approach to set up clinical trials.

This makes us uniquely qualified to expertly navigate the approval process and achieve rapid, efficient and cost-effective study start-up.

Our NHS background, also makes us ideally placed to negotiate budgets, confirm costings and arrange contracts on your behalf.

We will manage all interactions with the HRA including ethics approval, regulatory document management, clinical trial authorisation and local NHS Hospital approval. Our close working relationships with National Institute of Health Research (NIHR) and the Clinical Research Network enable us to effectively support clinical trials across the country.

Our experienced Regulatory Affairs specialists will ensure that documentation submitted is of the highest quality.

Our network of local regulatory experts across Europe together with our US and Australian partners ensure that these standards are maintained globally.

Prior to the trial, we arrange on-site training for staff which includes adherence to ICH-GCP.