Digital solutions to reduce risk potential for six-study dermatology programme

A large pharma company conducted an extensive atopic dermatitis program consisting of six studies with complex protocols and up to 537 active sites per study. The sponsor contacted ICON to implement a centralised digital solution to better manage this massive study and reduce risk potential. The FIRECREST team ensured a single, centralised system for the tracking of training and compliance across the whole program.

The sponsor’s main concern regarded site adherence to all protocols. With complex protocols across six studies, the sponsor wanted to ensure its sites had detailed, substantial training, including some rater training, plus the ability to revisit any training as needed. They also wanted improved on-demand access to training in anticipation of potential amendments and additional support modules added to the study.

Because two of the six studies involved paediatric patients, it was important to maintain ready access to information, documents and resources to diminish risk potential and maximise positive patient experience. Not all documents needed open access, some required targeted distribution to specific sites or members of the team.

In addition to consolidating and streamlining the training and document management systems, the sponsor was also keen to ensure that patient visits were efficient and stress-free. To improve patient visits, the sponsor wanted a system that could track training compliance in real time and give ready access to study-specific completion records.

The FIRECREST production team analysed the protocols and identified those procedures that were most open to risk, prioritising those that
needed the most attention for each study. Due to the scale and complexity of the program, we have pulled a representative example of the solutions we implemented through the study portal.

The protocol overview training was designed to ensure that sites could access content in clear, easily understood topics, particularly for phase 3 studies. The study’s FIRECREST portal hosted the Good Clinical Practice for Investigational Site Staff, Program Rater, and Safety Reporting trainings for easy access and completion tracking. The team also developed a visit-by-visit guide that was housed on the portal so that site staff could see what needed to be done to prepare for each visit, including detailed procedures that needed to be conducted for that visit along with instructions for the patient/caregiver before next visit.

The portal also hosted numerous trainings and facilitated data entry and eApproval for Principal Investigators to expedite reporting. Trackable trainings on the portal included: investigator payments solution, amendment training, CRO- specific training, adjudication training and serious adverse event reporting responsibilities study site
training. The study’s TrialDrive on the portal allowed for the timely, targeted distribution of documents to specific roles, countries or sites as needed.

After the FIRECREST implementation, the sponsor had a full program oversight system to manage compliance. They saw strong training completion figures across over 1,000 sites in the program, were able to track an average of 89.5% online training completion across all studies and achieved 47,999 mandatory training completions.