Southampton honoured for clinical trials data innovation during pandemic

An innovative approach to remotely monitor clinical trials in Southampton has been recognised with a national award.

Data management experts optimised a cloud-based clinical trials management system to support remote access at the height of the COVID-19 pandemic.

The partners from University Hospital Southampton and the University of Southampton have now been honoured for Team Excellence in the Management of Clinical Data.

They were presented the award at a special ceremony hosted by the Association for Clinical Data Management (ACDM) this autumn. Over 100 people joined the event, some in person at the venue in Manchester, and some virtually, to celebrate the achievement of their colleagues.

Remote monitoring in lockdown

The new approach was born from close collaboration between the UHS Research and Development (R&D) team and the EDGE team from the Clinical Informatics Research Unit (CIRU) at the University of Southampton. CIRU’s EDGE system is used in over a third of all NHS organisations.

The partners’ new tool allows sponsors to access trial information remotely, limiting the need for them to visit the site in person.

Dr Mikayala King, R&D Quality Assurance Manager at UHS, said: “We first discovered the need for remote monitoring at the beginning of the first lockdown. At that time, no visitors were allowed on site, not even those visiting patients, but we still had studies where participants were receiving treatment that needed to be monitored. We needed to come up with a way of doing that remotely.

“Once we started the conversation about EDGE, we knew we would need to validate that process which is a huge job to take on. We would also need to check in with our Information Governance and Information Security teams to ensure that they were happy.

“Myself and the R&D team at UHS are honoured to receive this award. This new approach has made a significant difference to the research team over recent months and it is fantastic to see it celebrated by the ACDM and NIHR.”

Project partnership

Kim Lee from the Quality Assurance team at the NIHR Southampton Clinical Research Facility led the important work of delivering effective governance and information security for the project.

Kim explained: “There were many factors to consider in order to ensure that the process was suitable for studies and effective communications between all parties involved were crucial. The study team has been very receptive to this process which helped the success of the project in partnership with the EDGE team.

“We are thrilled to have won this award, it is testament to the determination and hard work of the team over the pandemic.”

Beth Caruana, CIRU Marketing & Communications Specialist, said: “I know I can speak on behalf of the EDGE team that we are thrilled to win this award. It is always a pleasure working with our users from UHS and I am glad they have had this recognition for their hard work on this project, especially through devoting extra time and effort through such challenging times.”

Image caption: (Left to right) EDGE Knowledge Officers Arpana Basu, Roberto Aguiar and Jennifer Peach with R&D Quality Assurance Manager Dr Mikayala King and CRF Senior Quality Assurance Lead Kim Lee.