EDC(Electronic Data Capture)

About EDC

Streamlined Data Management for
Clinical Excellence.

Electronic Case Report Forms (eCRFs) are a fundamental component of modern clinical trials, offering a more efficient and secure way to collect and manage clinical data. XcelTrials provides a robust eCRF solution with the following features:

eCRF

There will be no more paperwork. In the electronic case report form (eCRF), collect and maintain all clinical data securely and anonymously.

Using research templates, you may quickly create an eCRF. Save time by having our specialists deploy all of your surveys in the eCRF.

Questionnaires can be saved, shared, and reused in a shared library.

Document management is used to keep all patient-related information in one place.

Single center & Multicenter studies

Multicenter trials are easily accessible to all participating locations.

Set up separate roles and associated privileges for each participating site using Role Based Access Control.

Clinical Subject Management

Participants can be enrolled in on-site, hybrid, or decentralized trials using XcelTrials eConsent.

Subject visit monitoring allows you to plan visits, keep track of registrations, and control drug issuance per participating facility.

To handle budgets and reimbursements, connect XcelTrials EDC to XcelTrials CTMS.

SUSAR/SAE

Register all SUSARs/SAEs associated roles.

Communicate with other roles within EDC about possible actions.

Data visualization & analysis

With study dashboards and real-time rapports, you can see all of your study information at a glance.

Results may be requested at the question or subject level using the built-in analytics tool.

Importing and exporting data

Data may be imported and exported from and to Excel (.csv, xls), SPSS, or any other required filetype.

Allow the eCRF to generate subject numbers and connect externally obtained data via Component Mapping.

EDC is part of the DCT platform

Combining EDC and Consent allows participants to screen and enroll remotely.

Use in conjunction with PRO to capture digital patient data during Hybrid or Decentralized Clinical Trials (DCT).

For studies that involve randomization, stratification, and inventory management, include the RTSM tool.

CTMS digitally archives all research-related information, including study documentation, approvals, budgets, reimbursements, and reports.

Good Clinical Practice (GCP)

Audit Trail

Data validation on field level

Anonymized patient details

Smart Safety Reporting

Role Based Access Control

Application Programming Interface (API)

Allow the EDC to easily interface with apps via an API.

Connect EDC to SURFcontext, a single sign-on (SSO), and an EPD. Furthermore, exchange data with financial and human resource systems, or stream data to the eCRF.

Paperless Data Collection

Say goodbye to paperwork. With XcelTrials’ eCRF, all clinical data is collected and maintained electronically, eliminating the need for physical case report forms and reducing the risk of data entry errors.

Secure Data Storage

XcelTrials ensures that all clinical data is stored securely and anonymously. The platform employs data encryption and access control to protect patient information and maintain data privacy.

Research Templates

Researchers can use pre-defined research templates to quickly create eCRFs for different clinical trials, saving time and effort in study setup.

Survey Deployment

XcelTrials offers the option for specialists to deploy surveys directly into the eCRF, streamlining the data collection process and ensuring that surveys are correctly integrated into the electronic system.

Questionnaire Library

The platform provides a shared library where questionnaires can be saved, shared, and reused. This feature is especially valuable for standardizing data collection across multiple studies or research projects.

Document Management

All patient-related information, including documents such as consent forms, medical records, and case reports, can be stored in one place within XcelTrials. This centralized document management enhances organization and accessibility.

Customization

eCRFs can be customized to match the specific requirements of each clinical trial or study, including data collection forms, validation checks, and data entry workflows.

Real-Time Data Access

Researchers and clinical trial personnel can access data in real time, allowing for continuous monitoring of data collection progress and early issue detection.

Data Validation Checks

Automated data validation checks help maintain data quality by flagging errors or inconsistencies during data entry.

Regulatory Compliance

XcelTrials ensures that eCRFs are compliant with regulatory standards, such as 21 CFR Part 11 and ISO 14155:2020, to meet documentation and reporting requirements.

Custom Reporting

Generate customized reports and analytics to assess the progress and data quality of clinical trials, supporting informed decision-making.

XcelTrials’ eCRF solution streamlines data collection, enhances data quality, and offers a secure and efficient way to manage clinical data for various research studies and clinical trials. It simplifies the research process and accelerates the development of new therapies and treatments.