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Why did Median Technologies adopt Datacapt eCRF for their studies?

“Median Technologies' team found that utilizing Datacapt brought several advantages, including real-time data entry monitoring, streamlined eCRF management, and comprehensive query tracking and resolution.”

Louis ChapototSenior Clinical Project Manager

2500+

Clinical Sites

220+

Studies

26+

Countries

+230

Professionals

Who is Median Technologies?

Median Technologies is an innovative Health Technology company. They deploy proprietary artificial intelligence, computer vision, and signal processing technologies to develop imaging tests and services, addressing life-threatening unmet medical needs. They transform medical images into meaningful, actionable insights to help better diagnose, treat, and monitor patients.

Median Technologies is headquartered in France (Sophia-Antipolis, South of France) with subsidiaries in the United States (Boston area) and China (Shanghai).

Median Technologies applies clinical expertise, proprietary technologies, and mastery of data science to generate valuable insights from medical images for oncology drug development and patient care.

With iCRO, the Company delivers differentiated and actionable insights having a significant impact on the success of drug development plans. The Company offers best-in-class end-to-end image management in oncology trials, providing global biopharma clients with key data on patients’ response to candidate drugs from Phase I through Phase III studies. Imaging Lab, Median’s enriched iCRO offering, drives drug development success with transformative AI-powered insights.

With iBiopsy®, Median deploys AI/ML tech-based Software as Medical Device (SaMD) to help health professionals diagnose patients earlier and treat them more effectively. iBiopsy® Software as Medical Device suite currently focuses on early diagnosis and improved treatment of lung cancer, liver cancer, and non-alcoholic fatty liver disease.

Median Technologies utilizes Datacapt eCRF to achieve better outcomes.

Before Datacapt

  • The complex nature of analyzing all reports and extracting information.

  • Tedious report structures and data exchange between different sites.

  • Difficulties in tracking the data entry process in real time.

  • Limited ability to make necessary changes to the eCRF when needed.

With Datacapt

  • A centralized and secure platform to structure the forms and ensure data integrity.

  • Enhanced security through a validated solution that meets all regulatory requirements.

  • Improved visibility with real-time reporting and progress monitoring.

  • Simplified data handling thanks to a user-friendly and easy-to-use solution.

Challenge

Median Technologies main challenges

Median Technologies encountered several challenges, including:

  1. Complex Radiological Reports: Analyzing radiology reports from different sites, and extracting information of interest from the reports is challenging.
  2. Structuring Reports: Providing a structured format for the reports was essential, as the data comes from different countries and different sites.

A change to their habits

Before implementing Datacapt, Median Technologies relied on their partners’ eCRFs.

However, it limited their ability to follow the data in real time during the data entry process. Besides, it also limited the ability to update the eCRF when minor changes were needed.

The solution

3 aspects that convinced Median Technologies to choose Datacapt

1. Data Structuring

They needed a tool to help structure their clinical data and radiological reports, ensuring that the information of interest was collected. It significantly improved their data collection and management process.

2. Audit Trail

For clinical validation studies, an audit trail is mandatory. Datacapt provided them with direct access to a complete and readable audit trail, fulfilling this requirement.

3. Meeting Criteria

Datacapt met all the criteria set by Median Technologies, including security requirements, fast and easy implementation, a validated and robust platform, an intuitive and user-friendly interface, real-time reports and progress monitoring, efficient user training, and responsive customer support.

An effortless implementation

The implementation and internal validation of Datacapt proceeded smoothly.

Median Technologies provided training to all users of the eCRF platform and issued training certificates. They also updated their processes to integrate the use of Datacapt.

”On-site users found the platform easy to use. Creating new studies was simple, allowing the development of complete eCRFs ready for data collection within a few days.

Jun ShenClinical Research Scientist

Studies conducted with Datacapt

Datacapt is used to structure the data from several US and EU clinical sites for verification and validation studies. The results of these studies will be used for regulatory submission of the product.

1st Study – Independent Verification Study: This study is designed to verify the performance of the product.

2nd Study – Clinical Validation Study: This study is designed to validate the product for its intended use.

4 advantages in using Datacapt

Easy eCRF Building

Datacapt made it easy to build comprehensive eCRFs, tailored to their specific needs and data collection objectives.

User-Friendly Interface

The platform’s user interface was simple and clear, enhancing usability and reducing the learning curve.

Easy Implementation

Implementing Datacapt was straightforward, with quick training, account creation, and limited access for each role.

Responsiveness and Support

The customer support provided by Datacapt was highly responsive, ensuring prompt assistance whenever needed.

Results thanks to Datacapt

A change seen positively

Median Technologies’ team found that utilizing Datacapt brought several advantages, including real-time data entry monitoring, streamlined eCRF management, and comprehensive query tracking and review.

Taking control of the data collection process enabled them to manage and analyze the data more effectively. Datacapt allowed them to create eCRFs tailored to their specific data collection objectives.

They saved time and much more

Datacapt enabled Median Technologies to focus on different tasks during their studies.

Although some time was dedicated to user training, the platform’s intuitive and user-friendly nature facilitated smooth training. Data entry monitoring became more manageable, and overall data handling became simpler.

Leveled up their security

Median Technologies considered a high level of security crucial.

They required an eCRF provider that guaranteed strong security measures and traceability. An audit trail was a mandatory requirement for their studies. Datacapt fulfilled all their security and compliance needs, being a Validated System, certified ISO 27001 and 21 CFR Part 11 compliant, as well as GDPR compliant.

Recommendation

“Based on our positive experience, Median Technologies would definitely recommend Datacapt to other research centers for their clinical trials. The platform's ease of use, real-time monitoring capabilities, and overall benefits make it a valuable tool for research endeavors.”

Louis ChapototSenior Clinical Project Manager

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