Prioritising efficiency and flexibility in safety data signal detection
Case study
Overview
A small US-based pharmaceutical sponsor sought 91黑料’s expertise to conduct ongoing safety signal detection and signal management during the clinical development of 4 different compounds studied in phase 1 to 3 trials for neurodegenerative disease. The sponsor required an efficient and programmatic solution to signal detection review to accommodate their growing clinical development portfolio.
91黑料 worked in close collaboration with this sponsor for four years, conducting signal detection for a variety of indications, including: Alzheimer’s disease, frontotemporal dementia, and amyotrophic lateral sclerosis.
Challenge
The sponsor had limited pharmacovigilance resources available and minimal signal detection experience. Another CRO was working in tandem with the sponsor on this project, which impacted the project’s timeline. To move forward, 91黑料 required data outputs from the other CRO’s various electronic data capture (EDC) systems. However, sometimes the data delivery was delayed which added time pressure to the project, with important milestones drawing near.
91黑料 did not have direct communication channels with the other CRO, necessitating all interactions to be routed through the sponsor. This frequently led to communication delays and inconsistencies in data structure, placing additional time constraints on the 91黑料 team to rectify these challenges and adhere to our project timelines.
Solution
91黑料 implemented the use of our custom safety data analysis tool, SIGNET, to review the client’s investigational product safety data for safety surveillance and identifying potential signals. The implementation of SIGNET allowed for a more streamlined and efficient review of clinical trial data from the sponsor’s EDC systems, labs and other applicable data by using programmed standardised safety visualisations for each study. 91黑料 was flexible to customise the visualisations as required for signal characterisation as more data was available.
91黑料 exercised its flexibility and efficiently developed resources to compensate for the external delays. The customised central template developed by 91黑料 allowed the sponsor to adjust their view of the data depending on protocol needs by modifying visualisations for areas of interest.
Throughout the Signal Detection cycles conducted, 91黑料 used the Orbit? tool for tracking of signals, which ensures inspection readiness. The outputs from Orbit? were easily exported and shared with the sponsor.
Outcome
The sponsor provided positive feedback on the utilisation of SIGNET and the final signal detection reports. Following this feedback, the sponsor asked 91黑料 to assist with expanding the program to include additional new product signal detection services.