The new standard for your clinical studies

Optimize the management of your clinical studies and focus on the essentials with our Datacapt solution.
A platform to promote your clinical study

Finally a secure solution that complies with regulations and will save your time and quality! Take advantage of a unique interface and adapted and easy-to-use features.

Why to choose Datacapt ?

The Datacapt solution allows the management of all stages of your studies. Developed with specialists in the field, our solution is scalable and offers you an optimal level of quality and security (EDC, eCRF, ePRO / eCOA, eConsent, data analysis, etc.)

All our prices are tailored to your needs!

Datacapt offers you according to your business based on the principle of monthly packages. Due to the great variety of our customers, we adopt the price according to the needs and use. Adapting our solutions according to your expectations and requirements is our priority.

FEATURES

eCRF/EDC

Designing your eCRF has never been so easy! Use a new generation, fun and fluid eCRF builder. Save time in building your simple or complex eCRFs.

  • Quick and easy construction of your eCRF (without code) in drag and drop
  • Organize and manage the structure of your eCRF forms
  • +12 types of questions available
  • Add real-time data consistency and validations
  • Create repeating measures and conditional questions
  • Create and use your eCRF templates to save time

 

ePRO/eCOA

Collect the data of questionnaires directly nearby of participants

The use of the ePRO module allows you to collect directly and without any manipulation all the questionnaires on site or at home.

  • Easily design your questionnaires in just a few clicks
  • Send questionnaires to patients / subjects quickly
  • Follow the results in real time
  • Directly access the data collected
  • Dedicated and secure space for each participant
  • Facilitate the monitoring and management of participants

eConsent

Secure consent module allowing you to easily manage subject consents and speed up the start of your studies in full compliance.

Reduce your consent process by more than 50% with eConsent

  • Creation of consent : Create your consent in minutes and send it to all subjects with one click, allowing you to greatly improve the participant experience.

  • Remote or on-site signature : The subject easily accesses a dedicated space in order to sign their consent electronically in complete security. A copy is kept and backed up in real time.

  • Starting your studies : Directly linked to your eCRF, you can access the rest of your study with complete peace of mind.

Simplify all of your process bound at consent and to win of time

  • Compliant with regulations (RGPD & 21 CFR PART 11)
  
  • Integration of your consents and multimedia elements (photo, video, etc.)
  • Improvement of the consent process
  
  • Dedicated and secure space accessible by the subject on different media
  • Better engagement of subjects during the clinical study
  
  • Simple and easy to use

eConsult/Telemedicine

Tele Consultation

Home study or Hybrid (on site / telemedicine) – Complete monitoring of volunteers & patients

 

Simplify the management of clinical studies carried out remotely, at the subjects’ homes, in a temporary site or in your laboratory. Linked to eConsent (electronic consent) eCRF and ePRO, consolidate the collected data securely and in full compliance.

  • 100% digital study (decentralized or hybrid)
  
  • Follow all the stages of the study directly on our solution
  • In connection with your eCONSENT, eCRF and ePRO
  
  • 100% secure and compliant (end-to-end encryption, HDS, RGPD)
  • Live teleconsultation with our solution

Data Processing

The new way to manage your mass data measured by testing instruments

Import your raw data provided by your measuring devices (Cutometer, Corneometer…), process all your values ​​quickly and easily in a few clicks thanks to our data processing solution.

Simplify the processing of instrument data

Your instrument data is automatically analyzed in seconds with our solution.

 Import of your raw data

 Import your raw data in Excel format exported from Monaderm’s CLS software, no prior processing is necessary.
Choice of relevant variables to analyze

 Analyze only the desired variables, access a complete summary of the results.

 A large number of compatible probes

 Our solution integrates the analysis of more than 10 probes: Cutometer, Sebumeter, Corneometer, Glossymeter …

Our Features

  • Exporting your results Export all your results in a few clicks and directly access the study reports.
  • Statistical studies% Our reports include statistical studies based on your raw data (student test).
  • Product / zone comparison Access comparisons according to products and study areas (product vs placebo, product A vs B ...)
  • Integration of your raw data All your raw data extracted from Monaderm's CLS software (Raw data and Area data) are integrated in order to have quick access to your sources.
  • Support Quick response to all user questions and complete, interactive documentation of the solution.
  • Automatic update Benefit from a reliable and intuitive next-generation solution and benefit from automatic and regular updates and maintenance of the solution.
datacapt- instrument

Data security and compliance

Learn more about the security of your data

security

Datacapt guarantees the security of your data with unique and secure access to your environment. All the information collected is transmitted only using the SSL / TLS protocol ensuring the encryption and encryption of your data.

21 CFR PART 11 compliance

Solution complies with the recommendations of 21 CFR PART 11. Full and nominative monitoring of user actions (Audit Trails), electronic signatures, access to the secure solution and backups …

 

Confidentiality

The implementation of encryption and protection mechanisms guarantees the confidentiality of your account and your data.

HDS Hosting & Outsourcing

HDS hosting of our solutions is provided by our French partner (certified on 6 HDS layers and ISO 27001). Solution hosted in France on ISO / IEC 27001: 2013, 27017: 2015, 27018: 2019 and 9001: 2015 certified servers. Outsourced backups of your data ensuring additional security.

Availability

A resilience system is in place to give you 24-hour access even in the event of an incident. The architecture of our solutions ensures you a stable and fluid production anytime, anywhere in the world.

 

Data & Logs

Hosting of all your data and backups in France. All of your data travels only through encrypted and secure protocols.