Rapid mobilisation to advance COVID-19 treatment development

In February of 2020, ICON quickly mobilised its vaccine and infectious disease resources to assist government and commercial clients in addressing the COVID-19 global threat.

One client trial investigating an antiviral treatment for patients with confirmed coronavirus infection required rapid patient recruitment, site selection, and study start-up across multiple geographies.

• Dedicated Clinical Trial Manager (CTMs): Enabling rapid responses to sponsor, site initiation, and providing after-hours / weekend coverage for urgent requests and initiation of new sites
• Dedicated cross-trained US Clinical Research Associates (CRAs): Facilitating rapid resource shifts to adapt to changing sponsor priorities. CRA team trained preemptively on protocol and study procedures for quick mobilisation
• Close collaboration with ICON resourcing team: Ensuring rapid deployment, onboarding and training for mobilisation to conduct visits in Korea, Singapore, and Japan
• Combined site assessment/SIV: Quickly developed process and templates enabling these important visits to be conducted in conjunction. Providing a consistent platform for how information is captured and reported to the sponsor for these visits
• Consistent, reliable infrastructure for communications: Ability to quickly arrange, run, control, and change if needed. Webex crucial to schedule meetings and invite sponsors/stakeholders to attend onsite visits remotely
  • Invited staff from multiple sites within one network to join Webex portions of onsite visits for other sites to obtain training on protocol, data system, processes and procedures. (SIVs have been running ~3 hours). Reduced site burden in hosting onsite visits which were shorted for these sites to tours, facility reviews, and operation instructions
  • Phone/video capabilities helpful for sites on lockdown have provided monitors with remote virtual tours of their facilities. Process generated for use and was quickly approved by the sponsor

• 75 sites planned
• 440 study participants recruited in US, Korea, Singapore, Japan
• Draft protocol review in 1 business day
• First Site Initiation Visit (FSIV) in 2 business days
• First patient Recruited (FPR) 1 day later