Contributing Expert: Shradha Prabhulkar, Manager of Clinical Affairs at Visby Medical
Since 2012, Visby Medical has been on a mission to transform infectious disease diagnostics and accelerate access to timely, effective patient care. For the past four years, their team has relied on Medrio CDMS/EDC for clinical study data management, recently leading to Visby’s first De Novo authorization.
Visby Medical began with a bold vision to transform diagnostics with rapid, lab-accurate PCR testing in the palm of your hand.
After launching their first FDA-cleared, CLIA-waived Sexual Health Test for use in a clinical setting, Visby continued to innovate. In 2025, the company made history again when their at-home Women’s Sexual Health Test received FDA De Novo authorization, becoming the first and only PCR test authorized for at-home use.
In our interview with Shradha Prabhulkar, Manager of Clinical Affairs at Visby Medical, learn how Medrio empowers:
- Comprehensive data collection and management
- Proactive, informed decision making
- Rapid study completion
Learn about how Medrio can empower your studies by connecting with our team.
About the Clinical Study
The pivotal study for the Visby Medical Women’s Sexual Health Test, which led to De Novo market authorization, was completed with ease due to Medrio.
Study specifics include:
- Study Type: Pivotal study
- Medical Device: PCR test for STI detection in an at-home setting
- FDA Pathway: De Novo
- Number of Participants: 2,200+
- Number of Sites: 13 geographically diverse sites in the U.S.
According to Shradha, their partnership with Medrio was “instrumental” in running a successful study.
Important areas of acceleration include:
- Less than a one-month study build
- Less than 45 days from last participant visit to FDA submission
This accelerated pace was made possible due to the speed, precision, and confidence provided by their partnership with Medrio.
Data Management Supports Market Approval and Beyond
For Visby, each recruited participant was a critical undertaking. “For a small company like Visby, this study was a huge investment, so we needed a partner we could trust with our data,” notes Shradha.
Maximizing the amount of data collected was also important. Beyond efficacy data, observational data, including a photograph, was needed. Medrio was able to efficiently support all of these data collection needs.
Plus, the ability to clean data during the study accelerated timeline completion. Visby was able to easily perform interim locks as each site finished entering data.
Medrio CDMS/EDC features that supported data collection and management include:
- Custom forms for capturing observational data
- Edit checks and automated queries
- Real-time image uploads for usability review
- Cohort segmentation as necessary
- Flexible, no-code updates to forms and workflows
Proactive Reporting Enabled Fast, Confident Decisions
The study team configured daily customized reports in Medrio. Near real-time snapshots of study performance allowed them to identify any issues quickly.
“Due to the exported reports, the clinical team was able to be very on top of all of the data,” says Shradha.
Medrio’s reporting and data oversight capabilities allowed Visby to:
- Identify potential issues
- Review and troubleshoot site data
- Save time, effort, and resources
Medrio’s reports also helped the team identify a necessary data collection change. “We just let the sites know this change is happening and to log out of the EDC. Then we pushed the change, logged back in again, and it was there,” notes Shradha.
Intuitive Software and Responsive Support Make the Difference
Even with a high volume of data and tight timelines, the Visby team needed minimal support during the study build.
Visby benefited from Medrio’s functionality and team through:
- Intuitive technology requiring minimal training
- Quick, responsive, and knowledgeable support team
- Trustworthy and efficient partnership
“Medrio’s products are super intuitive,” says Shradha. “You can just go in and start using it. Most of our CRAs only needed minimal training.” She also mentioned that even some of the more tech-averse PIs had no issues using Medrio.
The study team relied on Medrio’s expertise to resolve issues quickly. “The tech support team was phenomenal,” says Shradha. “They would solve our problem within hours. Having that kind of partnership, support, and trust was so important.”
Building on Success: Receiving FDA Clearance and Beyond
Visby’s partnership with Medrio resulted in an efficient study with high-quality data. Ultimately, Visby successfully received De Novo market authorization to market their at-home women’s STI test commercially.
Visby continues to use Medrio CDMS/EDC for clinical studies. Medrio’s edit checks and automated queries allow for rapid identification and correction of potential data integrity issues prior to manual review by CRAs. This single change reduced staff burden.
“We’re trying to fully leverage all of Medrio’s automation features to be nimble and fast while still producing quality data,” explains Shradha.
According to Visby Medical, Medrio made all the difference. When asked about Medrio, Shradha explains, “Medrio is super easy to use. It’s so intuitive that you can just go in and start using it. We’re excited to run more studies on Medrio, and we’re always excited to see all the new features you roll out.”
Learn about how Medrio can empower your trials by connecting with our team.
About Medrio
Trusted by sponsors, CROs and sites worldwide, Medrio aims to improve 100 million lives through faster, more efficient, and secure clinical trials. With almost two decades of experience, Medrio delivers proven, scalable solutions, unrivaled customer support, and guidance to the industry’s leading innovators, including pharmaceutical, biotech, medical device, diagnostics and more.
Our suite of solutions, including CDMS/EDC, eCOA/ePRO, eConsent, and RTSM, enables the capture of quality clinical trial data while optimizing workflows for regulatory readiness. Experience the power of Medrio and realize the full potential of your clinical operations and outcomes.
About Visby
Founded in 2012, Visby Medical is revolutionizing infectious disease diagnosis by empowering both physicians and patients to test for infections anywhere, anytime, with laboratory-grade accuracy. The company’s proprietary platform delivers true PCR results in under 30 minutes through the world’s first instrument-free, single-use PCR tests. Visby currently offers FDA-cleared tests for sexually transmitted infections (STIs) and respiratory infections. Visby Medical is actively expanding its platform to include a broad menu of future tests for both at-home and point-of-care use.
