A large, multi-national pharmaceutical company received an FDA finding in relation to low protocol training compliance for site staff. Following analysis, the issue was identified as being the use of multiple methods and the difficulty in tracking and reporting on training compliance across studies. The inconsistent methods of training across learning management also made it difficult to detect compliance gaps.

ICON deployed the FIRECREST Training solution on every study in the client’s portfolio. The role based user management feature was used to assign protocol training to all site staff working on studies. The training was available to be completed online and any training taken off line could also be recorded centrally on the FIRECREST Site Portal to give the organisation visibility of all training records across all studies.

Protocol amendment training was managed through the system so that all protocol training through the study lifecycle could be tracked and recorded in the same way. The solution also enables the client to be audit inspection ready by being able to report on training data from every study to regulatory authorities.

After leveraging the FIRECREST solution as its only site-facing training platform, protocol training compliance increased from 73% to 94% across the full portfolio of studies in 8 months. This resulted in the FDA closing their finding. The solution continues to be used across all studies in the clients portfolio with average protocol training compliance > 95%.