For drug development sponsors running global studies, each day on the path to market is precious. To help support sponsors’ accelerated study startup, our Central Laboratory Services (CLS) has enhanced its core systems and technologies to significantly trim typical startup timelines up to four weeks, reduce the time to implement potential study modifications after startup up to two weeks, and improve the overall quality of delivery.
The initiative represents just one way that CLS is working to build greater efficiencies into the drug development process and help sponsors reach patients faster, as part of a larger portfolio to increase agility through process improvements, organizational adaptations and enhanced technology. Lindsay Boehning, director of global project management, recently shared how global study startup represents a key area where sponsors can see considerable changes that shorten their timelines.
Enabling earlier startup behind the scenes
“When launching global studies, the team loads a unique database for each region of the world, such as North America, Europe, Latin/South America, and Asia Pacific. Working with separate databases has given the team greater flexibility to handle regional differences, such as the collection methods or the type of sample collection containers,” explained Boehning.
In the past, after receiving approval on the scope of work, the team would create a database for the first region, perform a quality review and develop the investigator and lab manuals along with requisitions for the region before starting on the database for the second region, followed by the third region, and so on.
Recognizing that this staggered process could be improved, we enhanced our core technologies so that each regional database can be automatically linked.
Now, as part of the Synchronized Global Study Start launch on August second, databases can be loaded and reviewed simultaneously. “Not only does this increase the efficiency and accuracy of the quality review process, it shortens the overall global study startup time. Global study startup can happen up to 4 weeks faster,” said Boehning.
Study modifications represent another common pain point that can extend a timeline each time protocols are modified to adjust the study design or add a new test. Now, with interconnected databases across the globe, any modification, small or large, can immediately be updated in other regional databases. What was once a manual process has become more streamlined and consistent, reducing the study modifications process by up to two weeks.
Creating a fast and flexible structure
“By using separate databases in each region,” Boehning continued “unique regional requirements are easier to manage in a robust system that enables greater efficiencies, while also accommodating customization requests. Coupled with the interconnected layers in the database, the turnaround time to load an entire protocol has been reduced and the structure links applicable study details across regions.”
Sponsors in the global study startup phase will see a significant reduction in their timelines and the team will be better equipped to manage special requirements, such as adaptive trials or regional variations. The team’s attention now turns to the next phase of the overall initiative to continue to improve oversight, reduce manual work and increase the overall quality and efficiency of study conduct in global clinical trials.