Supporting a Phase II study

With Novel Immuno-oncology Agent

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 
  • Selection of high performing sites, building on existing relationship and experience resulted in the UK having the highest recruiting site along with exceeding plan country recruitment by 30% Using highly experienced CRA resource supported a very positive working relationship with the sites enabling close monitoring and follow up across all site activities
  • The interim analysis was planned to take place during the peak of the COVID-19 crisis.  Following a full risk assessment of the project (considering no on-site monitoring visits between March and August 2020), remote monitoring and associated processes were promptly implemented. The revised process along with careful planning with the sites enabled the SDV backlog to be cleared and data cut off completed successfully
  • Aptus clinical were able to maintain stability in team members, not only benefiting the continued relationship with both sponsor and site staff.  To date Aptus clinical have been audited twice by the client, with no critical findings identified
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, Germany, Italy, Switzerland and France
  • 19 EU sites opened with 44 sites globally
  • The UK recruitment target was exceeded by 30% which also included the highest recruiting site in the study.
  • The interim data cut was met in October 2020 despite COVID-19 challenges. Prompt action implementing remote monitoring, along with flexibility within the team supported completion of this activity, resulting in a positive outcome.
  • Sponsor audit of Lead UK and highest recruiting site was conducted in preparation of potential FDA audit, resulting in no major findings
The Feedback

The client is delighted with the operational progress to date. The UK had the highest recruiting site, exceeding UK recruitment by 30% and achieved 152% of its global recruitment target on time in February 2020

We're delighted with the flexibility and agility Aptus have shown in supporting us so far. We feel they have supported greatly in accelerating our progress to date.


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