Global Phase IIIb and IV Clinical Trials

Whether it is comparative effectiveness, outcomes or increasing market penetration, ICON is well positioned to assist our clients achieve success.  Our approach capitalises on the expertise of our dedicated Phase IIIb/IV project operations group coupled with our extensive experience in scientific services and outcomes research.  This group is further enhanced by ICON’s global footprint and extensive therapeutic expertise.

Our approach is to bring together the best project teams globally utilising a dedicated team model which utilises fully integrated technologies, alternative risk based operational methodologies and adaptive designs to deliver high quality within specified timelines without placing undue burden on the overall project costs.  These services include:

  • Centralised Site Management 
  • Risk Based Monitoring
  • Site performance management system that boosts investigator site performance and study management (Firecrest Clinical)
  • Language Services

Expanded Access / Compassionate Use

Expanded Access Programs can take many different designs from Emergency Use, Named Patient Programs, Compassionate Use or Treatment INDs.  ICON capitalises on its strong regulatory strength and centralised operational methodologies integrated with a high use of technologies to effectively address the specific challenges each type of EAP may present within a given country or region.

  • Rapid and Ongoing Site Activation Process
    Unlike a normal clinical study, typically, start-up does not end after a certain number of sites are activated on a treatment protocol EAP project. Because of the nature of compassionate use, the study must remain open until the marketing application is approved.  ICON recognises the likelihood that a few sites may request to participate in the project well after the commencement of enrolment.  We utilise a centralised operational model which allows us to quickly deploy previously trained members of the study team to those new sites as they become known.  This is very important, as in many cases the site will have a potential patient already identified.  The actual magnitude of this factor will depend on the interest within the physician community

  • Management and Logistics 
    There are a few components like the one noted above which are inherently different within an EAP and must be managed efficiently.  Patient enrolment is crucial, for example.  The regulations stipulate patients must meet the criteria as per the intended use of the medication.  This means patients must be eligible.
    Another logistical issue inherent to some EAPs comes at the end of the project after the compound has received approval.  Patients still on treatment will need to be transitioned over to commercial product as applicable.  ICON has experience managing the logistics of this activity.

Effective site management is crucial in any clinical study.  However, an EAP project brings added importance to this area because of the potential make-up of sites utilised.  In compassionate use studies, often several of the sites participating may be research naïve.  ICON closely follows these sites providing ongoing feedback and training on the conduct of the study utilising an established and pressure tested process which ensures the quality of the data submitted.