Automate Key Processes for Clinical Operations
DrugDev Spark™ includes configurable eTrackers to automate key processes in clinical trials. We integrate and analyse incoming real-time data from disparate clinical systems, apply rules and trigger alerts that drive your unique objectives. Any process that relies on complex conditional logic or data integrations can be automated with DrugDev technology – and many would not be feasible without it – eTracker implementations include…
Once enrollment objectives are met, it becomes essential to minimise the number of patients who drop the study drug, become lost to follow-up, or withdraw consent. In order to help a top-10 sponsor manage a massive global trial with a low retention rate, DrugDev configured an eTracker to analyse incoming data from EDC, IVR and lab systems to identify indicators that a patient may be considering leaving the study. In such cases, sites were proactively notified with alerts that provided the appropriate intervention training in an attempt to keep those patients engaged. Using DrugDev technology, sites were able to reclaim more than 1,000 patients who had previously dropped the study drug, minimise the number of patients lost to follow-up, and reduce patient withdrawal to less than 1%.
A major pharmaceutical company was determined to improve patient diversity rates on an upcoming program of clinical trials for an indication that commonly impacts African Americans and Hispanics. They employed a number of effective tactics, including protocol design, Site Selection and targeted patient recruitment – along with DrugDev technology – to reach their goal. The eTracker monitored incoming enrollment data in real time, calculated ratios and determined which sites should continue, pause, stop or improve recruitment efforts. Site staff would check the status every day to see if enrollment was open for them, while the study team analysed reports and data to ensure they were tracking in the correct direction. As a result, the sponsor was able to randomise patients with an impressive 25+% minority participation.
Closeout Visit Scheduling
A global cardiovascular mega-trial with more than 20,000 patients had an aggressive 90-day window for completing all final patient visits. TIMI Study Group, the ARO on the study, referred to the daunting logistical challenge as “landing a jumbo jet.” DrugDev’s Closeout Tracker made this possible by proactively engaging sites with scheduling algorithms heavily weighted toward the beginning of the window to account for inevitable cancellations and postponements. Robust reporting and visualisations ensured that TIMI had the tools they needed to monitor and follow-up immediately with sites that did not schedule visits, had patients with missed appointments, or needed other support – ensuring that all sites around the world stayed on track. The jumbo jet successfully landed within the aggressive closeout timeline, and TIMI stated they could not imagine how they would have accomplished it without DrugDev technology.
How Can DrugDev eTrackers Help You?
Do you have a challenge that you can’t seem to solve with typical methods, or a dream for an automated process that doesn’t seem to exist in the market? Contact us to find out if a DrugDev eTracker can help you.