COVID-19 Study Builds at Pandemic Speed
The race to rapidly develop both a preventive and therapeutic intervention against COVID-19 has propelled the pharmaceutical industry into action at an unprecedented pace. The imperative to significantly reduce study build times calls for accelerated and agile adoption of technology, process, and resources. Speed, while ensuring study integrity, patient safety, and regulatory requirements, has never been more critical.
Catalyst Clinical Research, a clinical development organization, had to meet the challenge of enabling its customers to launch new trials and accelerate Study Builds at pandemic speed.
To build a COVID-19 treatment study, one of Catalyst’s sponsors required an aggressive timeline of only four weeks to launch. Catalyst had to pivot fast to respond, while supporting other ongoing studies which had been temporarily put on hold due to the pandemic.
Catalyst’s Corey Harrison, Data Manager, Catalyst Clinical Research spoke with Medidata’s Edward Ford, Senior Director, Client Engagement, to discuss how forces were combined to assess, design, and deploy the fastest path to expedite upcoming COVID-19 studies. Leveraging Medidata’s Study Build service expertise along with its Rave EDC and Rave Coder solutions, Catalyst successfully launched its first COVID-19 study in March 2020, just as the pandemic was hitting its first peak.
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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 monitors and CRAs from site access. Numerous challenges arose:
- Increased complexity getting necessary feedback from sites
- Study timelines slashed to a fourth of typical span
- Review cycles all had to be synchronized with the new truncated timeline
In addition, Catalyst could no longer leverage many of its prior forms due to the new study needs, and had to rapidly create and implement new forms.
Catalyst selected Medidata, as the partnership enabled them to overcome these new challenges. Catalyst relied on both Medidata’s service expertise as well as their technical capabilities to meet the four-week study’s timeline, adapt rapidly, and gain valuable, long-lasting efficiencies.
Rave EDC and Coder proved invaluable to expedite and streamline the study, as the user-friendly layout made data entry and coding easier and faster.
“Medidata’s Lab Administration module is a great resource; the query process is very straightforward and easy to understand—a powerful tool that helped us to enroll subjects ASAP.” - Corey Harrison, Data Manager, Catalyst Clinical Research
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 the study’s success was Medidata’s ability to set and adhere to its very aggressive timeline.
In addition to significantly accelerating the completion of its sponsor’s Study Build, valuable lessons were learned throughout. All parties involved in the project had to commit to aggressively rapid feedback and review cycles, reducing allocated time frames from weeks to days.
The ability of Medidata's Professional Services team to manage these shorter time frames, as well as team members’ willingness to prioritize their review and feedback responsibilities, drove expedited timelines otherwise rarely met. Leveraging Medidata’s experts and technology platform enabled everyone to understand and take advantage of the accelerated and shortened review cycles.
All stakeholders had knowledge of the forms available to them, furthering the study’s efficiency. The level of collaboration between Catalyst and Medidata helped drive communication between Catalyst and their sponsor, empowering all to identify and overcome each obstacle.
With a singular focus on study startup, and implementing software designed for reuse and speed, Medidata’s project manager worked with Catalyst every step of the way. Extending flexibility and assistance, they enabled Catalyst to optimize build times and launch the study within an extremely tight, unprecedented four-week deadline. Customizations that would have added time to the build and review process were avoided.
“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.”
Catalyst’s sponsor was thrilled with the outcome and contracted with Catalyst for future studies. Sponsors and CROs such as Catalyst Clinical Research leverage Medidata’s leading technology, combined with the most experienced study build professionals, to achieve the fastest study builds in the industry, experiencing reduction in study start from 14 weeks to just four weeks.
1. https://www.medidata.com/en/blog/clinical-trial-sites-share-frontline-insights-into-covid-19-impact/