Phase II uveal melanoma study: UK Biotech

The Challenge

Aptus Clinical was asked to support the EU delivery of a Phase II uveal melanoma study with a novel immuno-oncology agent

The Solution

An Aptus Clinical study team was established to support the identification, set-up and monitoring of UK sites. A partner CRO was carefully selected to support us in managing the other sites in Europe

The Outcome

The client and CRO contracts are in place to support the Aptus Clinical team in delivering an integrated solution. A number of key operational deliverables have been achieved:

  • Regulatory approval secured in UK, Belgium and Germany, with ongoing submissions in Italy and France
  • Ethics committee approval in 8 sites (UK, Belgium and Germany)
  • 1 site initiated (UK)

The Feedback

The client is delighted with the operational progress to date and has requested that Aptus Clinical conducts additional feasibility in the UK, Central Europe and other European countries to identify potential new sites