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A clinical trial platform is first and foremost a centralized tool for collecting clinical data.
It serves as the single source of truth where all data produced during a clinical trial are entered, consolidated, and stored over time, whether they come from:
- investigators (eCRF),
- patients (ePRO),
- clinical sites,
- connected sources (laboratories, devices, standardized questionnaires).
This data collection foundation is structured according to the protocol, governed by validation rules, and secured in compliance with regulatory requirements.
The Essential Components of a Clinical Trial Platform
An EDC System at the Core of the Platform
The EDC (Electronic Data Capture) module forms the foundation of any clinical trial platform. It enables the creation and management of eCRFs to collect patient data in real time. The platform provides an intuitive builder that requires no technical skills, with automated validations and consistency checks that ensure data integrity.
Integrated Complementary Modules
A comprehensive platform integrates several essential modules: randomization to automatically assign patients to treatment arms, investigational product management with full traceability, monitoring for quality oversight and query generation, as well as analysis and reporting tools that provide real time visibility into the study. Randomization can be linked to a therapeutic unit management module, enabling controlled and automated treatment allocation to participants while ensuring stock tracking, batch traceability, dispensing management, and consistency between the randomization scheme and the treatments actually administered.
A Collaborative Working Platform
Secure Access for All Users
A modern platform efficiently coordinates all stakeholders: investigators, clinical research technicians, monitors, data managers, and sponsors each have personalized access with granular permissions. The integrated audit trail records all actions (entry, modification, validation) and meets regulatory requirements (21 CFR Part 11, ICH GCP E6 R3).
Enabling Multicenter Studies
For multicenter trials, the platform allows instant data synchronization across all sites. Investigators can enter data from any location, while sponsors maintain a global view of study progress.
The Importance of User Experience
An Intuitive and Responsive Interface
Platform adoption depends largely on ease of use. A clear interface allows investigators to focus on their core tasks, with key actions accessible in just a few clicks and eCRF forms designed with a logical structure.
Responsiveness is critical: investigators can access data from a desktop, tablet, or smartphone, adapting to real-world operational constraints.
Simplified Training and Fast Onboarding
A well designed platform requires only minimal training. This accessibility shortens study startup timelines and contributes directly to the overall quality of collected data.
Datacapt: An All-in-One Platform for Your Clinical Trials
All Essential Modules in One Solution
Datacapt provides a comprehensive solution that brings together all required tools, from no-code eCRF creation to advanced randomization, investigational product management, and real-time monitoring. This all-in-one approach eliminates integration issues and ensures data consistency, while complying with international standards (21 CFR Part 11, CDISC, HDS, ISO 27001, ICH GCP).
A User Experience Designed for Everyone
The Datacapt interface is accessible to all user profiles. The eCRF builder makes it possible to create complex forms in just a few days, with more than 25 question types and validation rules added in a few clicks. The platform is fully responsive, allowing teams to work from any device.
Seamless Collaboration Across All Stakeholders
Datacapt turns the platform into a true collaborative workspace. Customizable dashboards provide each user with a role specific view. Configurable exports (XLSX, CSV, PDF) and built-in chart creation directly within the platform accelerate decision-making throughout the study lifecycle.
