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Qu'est-ce qui a déterminé Median Technologies à opter pour l'eCRF Datacapt ?

“L'équipe de Median Technologies a constaté que l'utilisation de Datacapt présentait de nombreux avantages, dont le suivi en temps réel de la saisie des données, une gestion simplifiée de l'eCRF, ainsi qu'un suivi approfondis des queries.”

Louis ChapototChef de Projet Clinique Senior

2500+

Sites d'études

220+

Etudes

26+

Pays

+230

Professionels

Qui est Median Technologies ?

Median Technologies est une entreprise innovante dans le domaine des technologies de la santé. Elle déploie des technologies exclusives d’intelligence artificielle, de vision par ordinateur et de traitement des signaux pour développer des tests et des services d’imagerie qui répondent à des besoins médicaux non satisfaits mettant en jeu le pronostic vital. Elle transforme les images médicales en informations utiles et exploitables afin d’améliorer le diagnostic, le traitement et le suivi des patients.

Median Technologies a son siège en France (Sophia-Antipolis, sud de la France) et des filiales aux États-Unis (région de Boston) et en Chine (Shanghai).

Median Technologies applique son expertise clinique, ses technologies propriétaires et sa maîtrise de la science des données pour générer des informations précieuses à partir d’images médicales pour le développement de médicaments oncologiques et les soins aux patients.

Avec iCRO, l’entreprise fournit des informations différenciées et exploitables qui ont un impact significatif sur la réussite des plans de développement de médicaments. La société offre la meilleure gestion d’images de bout en bout dans les essais en oncologie, fournissant aux entreprises biopharmaceutiques mondiales des données clés sur la réponse des patients aux médicaments candidats, de la phase I à la phase III des études. Imaging Lab, l’offre iCRO enrichie de Median, favorise le succès du développement de médicaments grâce à des données transformatrices alimentées par l’IA.

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 have joined the eCRF

Before Datacapt

  • Complex nature of all reports analysis and information extracts

  • Tedious report structures and data between all the sites

  • Difficulties to follow the data entry process in real time

  • Limited abilities to make changes to the eCRF when needed

With Datacapt

  • Centralized and secure platform to structure the forms and ensure data integrity

  • Upgraded security with a validated solution meeting all the regulatory requirements

  • Better visibility with real time reporting and progress monitoring

  • Simpler 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.
Median Technologies Datacapt

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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