The launch of Oncology Solution comes at a time when new FDA guidance, federal initiatives and revisions to scientific standards are changing the regulatory landscape for oncology clinical trials
Icon has announced the launch of Oncology Solution, a new service which it says will change the way oncology trials are conducted.
Oncology Solution is an integrated package of clinical services, delivering tumour imaging, central laboratory, integrated voice response solutions (IVRS) and case report form (CRF) data, designed to meet the endpoints pharmaceutical organisations need to understand their oncology compounds.
The launch of Oncology Solution comes at a time when new FDA guidance, federal initiatives and revisions to scientific standards are changing the regulatory landscape for oncology clinical trials.
By focusing on key endpoints such as objective response rate and progression free survival, Oncology Solution will enable the sponsors of drug trials to focus on the critical endpoints suggested by the FDA as being most appropriate for reviewing drug efficacy during cancer trials.
At the heart of Oncology Solution is the integration of medical imaging capabilities into all stages of the oncology trial including training, site selection, start up, monitoring, analysis and delivery.
This provides significant operational efficiencies for sponsors and enables the critical success factors and key project challenges to be identified pre-study rollout.
For example, investigational sites having the requisite imaging acquisition capabilities appropriate for an oncology study are identified at the start of the project.
Within Oncology Solution, each oncology trial is led by a senior project manager who acts as single point of contact across all the required clinical services.
Combined with real-time integrated reporting, this translates into efficiency gains for sponsors, reducing the required management and communication time across multiple services.
Andreas Dreps, Icon's global therapeutic head of oncology, said: "By integrating imaging into all elements of the clinical trial, Oncology Solution has redesigned the cancer drug trial.
"It enables levels of teamwork and operational efficiencies not achievable when contractual obligations separate the work performed within the same investigational sites and on the same clinical data".
Icon has extensive experience of running oncology studies having conducted over 225 cancer studies representing more than 46,000 patients and 4500 sites within 23 countries.
Alongside continued investment in highly qualified personnel with specific experience in oncology drug development, Icon has established relationships with over 500 oncology centres worldwide.
