Strategic study start-up support in the UK and Europe
Boyds was engaged to support a client in the US with study start-up services in the UK and France for a gene therapy study in patients with an ocular condition. The client had already contracted a CRO to set up sites in the US and approached Boyds to perform the regulatory and ethics committee submissions in the UK and France, as well as set up five sites ready for initiation. In addition, Boyds were requested to complete the GMO submission in France.
Boyds worked in partnership with the client and the US CRO to ensure all the study submission documents were reviewed according to local requirements and that the translations were completed in line with the project timelines. Boyds also prepared and completed the submissions in both countries in parallel to setting up and preparing the 5 sites for activation.
Both Boyds and the CRO SOPs were used depending on the tasks that were being delivered. The contract review process was facilitated by the CPM in the UK and the CRA in France, working closely together, with multiple team meetings each week.
Impact and Outcomes
The client and the CRO were both delighted with Boyds input, and we are continuing to provide regional strategic support to this client as their study progresses through the recruitment and treatment phase.