EDC

Dacima EDC (Electronic Data Capture) is a clinical data management system (CDMS) designed for CROs, pharmaceutical companies, government agencies, research institutions, and universities. The platform captures, manages, and reports on clinical research data across a range of study types, including randomized clinical trials, observational studies, patient registries, and administrative clinical databases, all from a single configurable system.

The platform is built around direct data entry in real time, incorporating digital Direct Data Entry (DDC), electronic Patient Reported Outcomes (ePRO), electronic Clinical Outcomes Assessment (eCOA), electronic Diaries (eDiary), and eConsent (eCON). This integrated eSource approach eliminates the need to transcribe data from paper records, reducing errors and saving time.

Core Platform Capabilities

• Flexible database design supporting clinical trials, observational studies, patient registries, and administrative databases without requiring separate software packages for different study types.
• Scalable architecture that can be adjusted to meet the demands of studies of varying size and complexity.
• User-configurable parameters including sophisticated eCRF design options, edit checking, conditional logic for skip patterns, dynamic form activation, and external source data import.
• Compliance with FDA 21 CFR Part 11, Good Clinical Practices (GCP), and regulatory requirements from EMEA, PMDA, FDA, and ICH.
• Web-based database development that does not require computer programming expertise and is accessible through any web browser.

Data Validation and Form Design

• Real-time validation controls, skip patterns, and formula calculations within and across forms.
• Dynamic logic for form activation and deactivation based on entered data values.
• Subforms embedded within main forms to create a more fluid data entry experience.
• Tabular display of data entry items and panel-based form sections.
• Forms can be designed to closely resemble existing paper questionnaires or Case Report Forms.

Reporting

• Built-in standard reports available out of the box.
• A query builder that allows users to extract specific data and create custom reports without programming knowledge.

DICOM Image Viewer

• Upload DICOM format image files directly into CRFs.
• View images with annotation and measurement capabilities.
• De-identification and anonymization of patient identification information on upload.
• Batch extraction of DICOM files, either manually or on a scheduled basis, to an sFTP site.

Offline Data Collection

• An offline module supports data collection in areas with poor or limited internet connectivity.
• The system automatically generates a client application from the web database, replicating the interface, validation checks, form design, data querying, and collection workflow of the master web database.
• Research staff can collect data electronically without internet access.
• When connectivity is restored, the software synchronizes with the online version by comparing and uploading only the changes made, optimizing performance on low-speed connections.

Digital Gift Integration

• Integrates with Rybbon to allow delivery of incentives to clinical trial participants.
• A Recipient Data Masking option enables anonymous reward delivery, so participant identities are not exposed.
• Rewards can be redeemed in more than 150 countries, supporting international studies.

Dacima EDC is available as a trial version and can be demonstrated through a personalized session. The software is developed by Dacima Software Inc., which is part of the EvidentIQ Group.