A leading biotechnology company contracted ICON to run a large number studies across Phase I to Phase III programs in a number of therapeutic areas including oncology, cardiovascular and dermatology. It was acknowledged that there would be significant challenges in trial execution in relation to management and delivery of training and document distribution to sites due to the volume of sites and wide range of geographic locations. The sponsor needed an integrated solution to ensure operational efficiency and training compliance.

The ICON team worked closely with the sponsor to deploy the FIRECREST solution across all of the trials with the objective of enhancing education and making it easier for site and study staff. The FIRECREST learning management solution (LMS) was used to centralise the delivery, tracking, and reporting of training requirements for site staff. The FIRECREST Protocol Overview eLearning module, a highly engaging and immersive training module was deployed to improve comprehension of study protocols.

To overcome the challenges of managing distribution of documents e.g. protocols, informed consent forms, vendor manuals, and follow-up letters to sites, the FIRECREST TrialDrive solution was selected. Using this solution, the study team was able to instantly distribute documents to sites and update existing documents with new versions to ensure ongoing version control.

Deployment of the FIRECREST solution has been critical to driving operational success on the program of studies. The FIRECREST LMS has been used to track 80,000 training completions for 11,000 users. This has saved the study team significant time in the delivery of training and management of training records. By centralising training records, it has also ensured each study is inspection ready in the event of an audit. In addition, the solution has helped drive the quality of data in trial execution. Up to 90% of site staff completed the FIRECREST Protocol Overview training designed to improve comprehension of the protocol, even though there was no mandate to do so.

The FIRECREST TrialDrive solution was also crucial in reducing administration burden associated with document distribution. Over 10,000 documents were distributed to sites securely through the solution that were viewed a total 50,000 times. The solution also has given sites one central location to access all documents, reducing their document management burden. User feedback from a site survey has been very positive to date with over 95% of survey respondents indicating they were either very satisfied or satisfied with the FIRECREST solution.