The race to rapidly develop both a preventive and therapeutic intervention against COVID-19 drove the pharmaceutical industry into action. The pandemic propelled urgency for sponsors to adapt and respond to trial requirements evolving at an unprecedented pace.
The imperative to accelerate study builds for faster time-to-market demanded the adoption of new technology, processes, and resources. It also gave CROs and sponsors an opportunity to fundamentally evolve their technology approach and leap into the next generation of clinical trial solutions, far beyond COVID-19.
Video preview: Access the full video here.Speed: Paramount Amidst All Disruptions
Within weeks, the pandemic forced 45% of sites to transition patients from in-person to remote visits¹. It also prevented or limited site access for monitors and CRAs. Adaptive speed became the essential ingredient for faster time-to-market, optimal performance, and transformation in times of change.
Challenges launching new trials arose in a matter of days:
- Study timelines slashed to a fourth of typical span
- Enrollment of patients, mostly remote
- Lack of forms and documents adapted to the pandemic
- Increased complexity getting necessary feedback
- Review cycle synchronization with new truncated timeline
In early 2020, Catalyst Clinical Research, a clinical development organization, sought the optimal path to enable its customers launching new trials through COVID-19's first peak in the United States. To overcome these new challenges Catalyst turned to a company experienced in creating end-to-end solutions to support the entire clinical development process, relying on its professional services team and technical capabilities to meet a four-week study's timeline to launch.
"I've been in the industry for quite a few years. I've been involved in a lot of database builds. This was by far the quickest I've ever been involved in for a full study build."
-Corey Harrison, Data Manager, Catalyst Clinical Research
To meet the critical deadline, Catalyst leveraged EDC and Coder solutions to expedite and streamline the study. User-friendly layout made data entry and coding easier and faster. Unable to leverage many of its prior forms due to the new study needs, Catalyst also would have had to rapidly create and implement new forms but instead was able to use an array of pre-authorized standard forms from its partner's global library, which helped get the trial up and running faster.
Learning at Pandemic Speed
Critical to building, launching, and successfully driving faster study start is the ability to set and adhere to CROs' and sponsors' very aggressive timelines.
With a singular focus on study startup, and software designed for reuse and speed, the Study Build experts worked with Catalyst every step of the way to enable all stakeholders to understand and take advantage of shortened design and review cycles. All gained immediate knowledge of the data, forms, and solutions available to further study efficiency.
By translating requirements into innovative technology solutions geared for long-term success, while delivering faster quality Study Builds, sponsors and CROs can expect to achieve:
- 70% reduction in study build time over industry benchmarks
- As fast as 2 weeks to FPI for the most rapid implementation times
- 61% higher reuse of eCRFs to reduce build and testing times
- Patient enrollment in as fast as 2-4 weeks
“Once the build is done, you need a Lab Administration module where the query process is very straightforward and easy to understand—we had a powerful tool that helped us to enroll subjects ASAP.”
-Corey Harrison, Data Manager, Catalyst Clinical Research
Comprehensive collaboration between Catalyst and Study Build professional services also helped drive communication between Catalyst and their sponsor, empowering all to identify and overcome each obstacle.
Catalyst launched the study within an unprecedented four-week deadline. Customizations that would have added time to the build and review process were avoided. Catalyst's sponsor met its time-to-market objectives and contracted Catalyst for future studies.
Sponsors and CROs such as Catalyst can leverage best-in-class end-to-end technology solutions delivered on a unified platform, combined with the most experienced study build professionals and an array of Specialized Programs, to achieve the fastest study builds in the industry.
Not only do they speed time-to-trial launch, they also gain autonomy and agility, improve performance, and minimize risk by establishing study control and oversight, adapting technology as trials adjust, and achieving on-demand scalability as trials evolve.
Using a best-in-class end-to-end solution delivered on a unified platform and a team of experienced study build experts, Catalyst achieved one of the fastest study builds in the industry.
By leveraging best practices from a community of experts, Sponsors and CROs can design for end-to-end implementation, avoiding unnecessary programming and risks and streamlining trial technology. They establish their own standards within a flexible platform, while retaining control over their study data, centralizing and supervising data access.
References
¹ https://www.medidata.com/en/blog/clinical-trial-sites-share-frontline-insights-into-covid-19-impact/