CovarsaDx, a leader in IVD and medical device clinical trials, faced a common challenge: efficiently managing vast amounts of complex trial data while ensuring precision and compliance. In an industry where every second counts and accuracy is critical, CovarsaDx partnered with Mednet to take a transformative approach to data management. Using Mednet’s intuitive platform, iMednet, CovarsaDx streamlined clinical trial processes and reduced trial build times from weeks to days, solidifying its position as an innovator in clinical research.
Expertise in IVD and Medical Device Trials
Specializing in managing IVD and medical device trials, CovarsaDx excels in handling both simple and complex studies, always prioritizing regulatory compliance and data accuracy. By leveraging available technologies, they deliver high-quality results efficiently, meeting the demands of a dynamic industry.
The Challenge
Before adopting iMednet, CovarsaDx faced significant hurdles in managing clinical trial data, particularly for complex studies requiring multiple data points and follow-ups. Their trials ranged from single-visit respiratory studies to intricate inpatient participation, necessitating a robust system capable of handling diverse requirements while ensuring data integrity and regulatory compliance.
Why CovarsaDx Chose to Partner with Mednet
Mednet is a premier provider of eClinical solutions tailored to streamline clinical trial management, with extensive experience in the IVD and medical device sectors. Their feature-rich platform offers advanced tools, including:
- Electronic Data Capture (EDC)
- Electronic Patient-Reported Outcomes (ePro)
- Digital Imaging and Communications in Medicine (DICOM)
CovarsaDx selected iMednet for its intuitive interface, flexible pricing, and outstanding customer support. Key features like study replication enabled them to launch trials in days, dramatically reducing build times. The templating and study environment copying features further streamlined workflows, eliminating redundant tasks for new client studies. Integration capabilities, such as API connections with lab instruments and CSV file imports, reduced administrative burdens on clinical site staff and research associates, enhancing monitoring efficiency.
Seamless Implementation
The integration of the iMednet platform into CovarsaDx’s workflow was smooth and supported by Mednet’s comprehensive training resources. Designer guides and lunch-and-learn sessions facilitated a seamless transition, while the platform’s user-friendly design allowed the team to quickly adapt and optimize operations.
Powerful Solutions for Clinical Trials
iMednet’s features have been instrumental in advancing CovarsaDx’s clinical research capabilities. The platform’s EDC, API integration, and adjudication module have been used across studies ranging from over-the-counter products like rapid antigen tests for respiratory diagnosis and women’s health devices to more complex studies researching biomarkers and early detection of life-changing disease states. Additionally, the system’s ePro module has been integrated into several studies, with plans to expand its use in future decentralized trials. For upcoming inpatient and complex diagnostic trials, CovarsaDx plans to explore the iMednet DICOM module, to see how it can further enhance their data management capabilities.
The ability to quickly adjust role permissions has improved collaboration across teams, ensuring each role has the necessary visibility and access for efficient operations. The flexibility of exporting data in multiple formats has also streamlined reporting and made it easier for all stakeholders to access the information they need.
Results and Benefits
Mednet’s ability to replicate studies and create templates has significantly reduced trial build times, accelerating time-to-market for CovarsaDx’s clinical trials. Customizable reporting and efficient data export capabilities have improved data accuracy and compliance. Roles across the board—from sponsors and data managers to statisticians and trial sites—have experienced increased efficiency.
This partnership has been pivotal in CovarsaDx’s success, enabling them to meet their goals of delivering accurate, efficient, and compliant data management. With Mednet, CovarsaDx remains at the forefront of clinical trial innovation, upholding the highest standards in IVD and medical device research.