Digital solutions for speed, agility and remote management

One of the top five pharmaceutical companies in the world selected ICON to initiate, manage and operate a phase 1/2/3 randomised, placebo-controlled vaccine clinical trial for SARS-CoV-2, the virus that causes COVID-19. ICON was tasked with this observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity and efficacy of RNA vaccine candidates against COVID-19 in healthy adults. We had a global team of 1,000 people supporting the trial with more than 150 clinical trials sites across the United States, Germany, Turkey, South Africa, Brazil and Argentina.

This was a complex, adaptive trial design in a quickly evolving healthcare environment which anticipated rolling regulatory data submissions and was likely to
have multiple amendments to ensure data integrity and diversity of population. Each of these multiple amendments required re-consenting and tight version control.

The rapid spread of the virus, travel restrictions and resultant cancellations and site closures required the team to get the study portal in place as quickly as possible to begin the trial.

As COVID-19 cases rose globally, the increased risk of infection heightened the anxiety of patients during site visits and complicated on-site logistics with the
additional PPE and social distancing measures. Despite these challenges, the team needed to deliver a vaccine as quickly as possible.

Agile, flexible digital solutions for remote management during COVID-19

The site portal for this study was available within just one week – half of the standard development time. The sponsor teams leveraged the expedited learning management system to manage all training assignments and ensure staff was consistently trained in protocol and operational details, along with study-specific training modules and the customised visit planner. Remote study staff could review training records and scan Informed Consent Forms to the portal to ensure full compliance.

TrialDrive allowed for the management and targeted distribution of eDocuments, including the three protocol amendments posted within the first six weeks. With the portal in place with trial-specific solutions, the sponsor communicated quickly and effectively with all site and study teams and promptly rolled out subsequent protocol amendments.

Expedited solutions for site and study staff 

Users were added continually from reports every two hours rather than the standard 72-hour turnaround to increase resources and facilitate faster patient screening. FIRECREST expedited the delivery of study-specific modules, reducing the time to almost 24 hours. Additionally, 40 training modules were created for this study’s 6,500 enrolled users with an accelerated approval process to meet the sponsor’s
timeline.

Strong communication and quality management in an evolving environment

Maintaining high quality standards under time constraints required collaboration and strong communication between FIRECREST and study partner teams. Early and frequent communication on roles, responsibilities and project status, particularly on upcoming challenges and solutions, helped fully align all stakeholders at every stage. As a result, there were no critical findings in the several regulatory audits conducted during the trial.

ICON deployed a cadre of tailored FIRECREST digital solutions over 150 sites in multiple countries. These tools and systems were vital elements of the trial’s success. The learning management system assisted in training and tracking completion for over 80,000 site staff in four months, while Financial Disclosure accelerated start-up activities and TrialDrive managed the distribution of eDocuments. The joint efforts of the sponsor and ICON teams resulted in the approval of a first-of-its-kind mRNA vaccine against a novel virus that went from initiation to emergency use authorisation in the US and UK in just nine months.