AI TOOL PROFILE
diCELLa eCRF Clinical Trials: Clinical Trial Management Software
- Healthcare
- Clinical Trial Management
- Biopharma and Biotech companies
- Contract Research Organizations (CROs)
- Academic researchers
- Medical device companies
Pricing
Pricing was not clearly available from the provided evidence. Buyers should confirm current pricing on the vendor website.
At a glance
- Best for
- Biopharma and Biotech companies, Contract Research Organizations (CROs), Academic researchers, Medical device companies
- Key use cases
- Clinical Trial Data Capture, Participant Randomization, Drug Supply Coordination, Regulatory Document Organization, Recruitment Tracking
- Official website
- Visit dicella ecrf clinical trials official website
How AI is used
diCELLa is a web-based Electronic Data Capture (EDC) platform designed for clinical trials. It includes several modules, such as electronic Case Report Forms (eCRF), a Clinical Trial Management System (CTMS), and Interactive Web Response Systems (IWRS), to help researchers digitize trial data and monitor progress.
The software is designed for users including medical device companies, CROs, biopharma companies, and academic researchers. It supports the transition from paper-based records to digital formats and provides tools for site monitoring, patient enrollment, and budget management.
Buyers should note that the system is built on a Python and Django stack and is designed for regulatory compliance, including standards such as 21 CFR Part 11, HIPAA, and GDPR. The company offers implementation services to set up the system based on study protocols.
Potential users should confirm the specific requirements of their trial phases and the level of customization needed, as the vendor provides tailored solutions based on individual client needs.
Key Features
eCRF Module
Digitizes Case Report Forms to capture clinical trial data electronically.
CTMS Module
Supports trial oversight with tools for recruitment analysis, site monitoring planning, and budget management.
eTMF and eISF Management
Provides digital repositories for trial documents and investigator site files with version control.
IWRS Module
Supports patient enrollment, randomization, and tracking of drug supply and dispensing.
Blockchain Data Security
Uses a patented blockchain approach to help secure medical and laboratory data.
AI and ML Support
Includes machine learning algorithms to support researchers during trial design and execution stages.
Regulatory Compliance
Designed to meet 21 CFR Part 11, FDA, HIPAA, GDPR, and ICH GCP standards.
Use Cases
Clinical Trial Data Capture
Converting paper-based CRFs into electronic formats to support data entry and validation.
Participant Randomization
Using the IWRS module to automate the assignment of participants to treatment groups.
Drug Supply Coordination
Monitoring drug inventory and managing the dispensing of investigational products across trial sites.
Regulatory Document Organization
Storing and organizing study protocols, ethics committee approvals, and informed consent forms in an eTMF.
Recruitment Tracking
Analyzing enrollment progress through the CTMS to monitor participant recruitment.
FAQ
What is diCELLa eCRF used for?
- It is used to establish and manage electronic Case Report Forms (eCRFs) for clinical trials, transitioning data collection from paper to a digital database.
Is diCELLa compliant with healthcare regulations?
- Yes, it is designed to be compliant with 21 CFR Part 11, FDA requirements, HIPAA, GDPR, and ICH GCP, and holds ISO 9001 and 27001 certifications.
How long does it take to implement the system?
- The vendor states that a demo version of the system can be provided in less than 5 days, with final implementation typically completed within one month.
Source category: Healthcare
Source subcategory: Clinical Trial Management
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