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Evidence_EDC_Electronic_Data_Capture

ACCELERATE TRIALS AND SIMPLIFY COMPLEXITY

Dacima Clinical is a cutting-edge EDC and CDMS for clinical research data. It captures, manages, and reports on every detail in order to optimize your research data processes. Dacima Clinical has been designed for the needs of CROs, pharma companies, government agencies, research institution and universities alike.

Single Platform - Flexible, Scalable, Configurable

Flexible

Design databases for any of your organization’s clinical data collection needs
Whether you are conducting a clinical trial, an observation study, a patient registry or need to design an administrative clinical database. No need to purchase and maintain different software packages for different study designs.
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Scalable

Highly scalable architecture and compliant with GCP and FDA 21 CRF P11
Cost-effective, whether managing a single clinical trial or study or a large multi-centre international study. There is no need to compromise depth of functionality for ease of use and efficiency.
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Configurable

The most advanced electronic data capture and clinical data management system.
With user-configurable parameters, sophisticated eCRF design options, edit checking, conditional logic for incorporating skip patterns, dynamic form activation, external source data import and other advanced options.
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UNPARALLELED INTEGRATION

IMPORT DATA FROM ANY OTHER SOFTWARE

ODM-XML* is a vendor-neutral, platform-independent format for exchanging and archiving clinical study data. ODM-XML includes all information (clinical data, along with its associated metadata, administrative data, reference data, and audit information) necessary to share among different software systems during study setup, operation, analysis, submission and for long-term retention as part of an archive to facilitate the regulatory-compliant acquisition, archive and exchange of metadata and data. ODM has become the language of choice for representing case reports form content.

DICOM IMAGE VIEWER

UPLOAD DICOM FORMAT IMAGES INTO CRF

Upload DICOM files and view them with annotation and measurement capabilities. We offer de-identification/anonymization of patient identification information option on upload. Batch extraction of DICOM files (manual or scheduled) extraction to sFTP site.

FEATURES

DESIGNED FROM THE GROUND UP WITH ITS END USERS’ NEEDS IN MIND

Powerful Web Database Development

Allows you to develop databases without the need for computer programming expertise and access them through any web browser independent of the operating system.

Flexible, Commercial Technology

Activating or deactivating features, the software can be easily tailored for different research study designs, such as randomized clinical trials, observational epidemiological studies, patient registries, patient interviews or administrative databases.

Auditable and Fully Compliant

The system complies with FDA Part 11 regulations, can be used for data collection in clinical research such as for randomized clinical trials, and is compliant with Good Clinical Practices (GCP) and regulatory requirements (FDA and ICH). Every change made to the data leaves an audit trail so it can be identified.

Reporting Made Easy

Built in standard reports for clinical research and query builder allowing for extraction of specific data and creation of data output for custom reports without the need for programming.

Achieve More Accurate Results Faster

Data validation and quality control features for validation checks, skip patterns, formula within form or across different forms. Dynamic logic for form activation/deactivation to trigger forms based on the data values entered alongside validation controls executed in real time.

Forms That Are Easy to Use and Understand

Embed subforms within main forms creating more fluid and user-friendly experience, simplifying the data entry process, and increasing data entry efficiency. Create tabular display of data entry items and split your form into sections using the panels feature. Create forms that closely resemble your paper questionnaires or Case Report Forms.

"Dacima Clinical is an easy to use software with all the required components to manage the study data autonomously. Nicole Lupien, MIREC Study Coordinator"
Nicole Lupien
MIREC Study Coordinator