Improved adherence in a high-risk immunology study for a small biotech

A small US based biotechnology company sought ICON’s assistance for a high-risk immunology study with heavy investment and limited resources. The study was a phase 3 Lupus SLE study with a complex protocol governing 90 sites. The sponsor had not previously invested in training and compliance tracking and the implementation of ICON’s FIRECREST system represented a strategic move from paper-based tracking to an agile, automated system.

For this trial, the sponsor wanted to ensure adherence to the complex protocol across all sites and establish a system that could track all training compliance in real time while providing ready access to completion records. The plan to ensure compliance included detailed, substantial training plus the ability to for staff to revisit training as needed, along with improved accessibility to information, documents and resources to diminish risk potential. Site staff required access to training relating to any potential protocol amendments to stay up to date and the sponsor needed a way to prove staff acknowledgement of particular documents as
distributed by the team.

To fit the sponsor’s needs, the ICON FIRECREST production team first analysed protocol and identified those procedures that were most open to risk. The team developed an interactive protocol overview training to ensure that sites could access the content they needed through clear, easily understood topics. This overview training was crucial as the sponsor had previously operated primarily with paper-based systems and were beginning their investment in a digital, automated system.

ICON created a visit-by-visit guide to clearly illustrate to site staff what preparations were needed before each visit. The guide also detailed the procedures that required at that visit along with instructions for the patient before the next visit. The FIRECREST team also established TrialDrive on the portal to allow for the targeted distribution of documents to specific roles, countries or sites as needed. In addition, the ICH GCP training was made readily available to complete.

Despite the challenge of moving the small biotech company’s team from paper-based tracking systems to a new digital system, it was a successful migration and study. The sponsor team took to the FIRECREST system and saw strong training
completion figures and improvements in compliance. TrialDrive on the study’s portal was consistently used for targeted, trackable document distribution. TrialDrive hosted 59 published documents, facilitated 2,544 document views and tracked 839 records of document acknowledgement. The training and document records were always accessible in real-time at training, study, site and individual levels. FIRECREST’s agile, digital solutions enabled the team to monitor compliance at every level and helped improve site adherence.

The small biotechnology company has since been acquired by a larger pharmaceutical company. As a result of the success of FIRECREST on this study, the platform is now being considered for enterprise deployment across the larger pharma company.