About DDi-mEDC
DDi-mEDC is a data management software from Makro Care that is designed for electronic data capture and management in clinical trials. It provides features such as real-time data monitoring, secure data storage, and compliance tracking so organizations can effectively manage clinical data. The software helps facilitate regulatory compliance and improves data accuracy through automated processes. DDi-mEDC supports integration with various clinical systems, enabling efficient data flow and reporting. Key capabilities: real-time data monitoring secure data storage compliance tracking automated reporting system integration Best for: clinical researchers and organizations that need to manage and analyze clinical trial data efficiently.
DDi‑mEDC is a purpose-built electronic data capture (EDC) solution developed by Drug Development Informatics (DDi) to meet the unique requirements of clinical trials, particularly those focused on late-phase, observational, and real-world evidence studies. Unlike some generalized EDC tools, DDi‑mEDC is specifically designed to address the operational complexities of post-marketing surveillance and long-term safety studies, offering a robust, compliant, and scalable environment for collecting and managing clinical data. One of the core strengths of mEDC lies in its quick study setup capabilities, supported by DDi’s broader clinical services ecosystem, which includes clinical data management (CDM), biostatistics, and pharmacovigilance. This tight integration between technology and service allows sponsors and CROs to execute trials faster while maintaining regulatory compliance and data integrity. The platform incorporates standard EDC features such as user-friendly case report forms (CRFs), automated edit checks, audit trails, and query management tools, all aligned with global regulatory standards including ICH GCP and 21 CFR Part 11.
Pros & Cons
- +Reduces data cleaning time through strong edit checks and auto coding.
- +Allows quick response to protocol amendments with versioning and data migration.
- +Supports both paper and electronic CRFs, offering flexibility.
- +On‑demand reporting and exports to multiple formats aid decision‑making.
- +Lower cost and fast deployment compared to many full‑scale EDC/CDMS tools.
- −Some advanced integrations with external systems may require custom work.
- −User interface & user experience details are shallow in available materials.
- −May lack some highly specialized features that large CROs or pharma vendors expect.
- −Training or domain expertise might still be needed to use all capabilities optimally.
Features
Key features
- Core CDMS Functionalities
- Study design & setup, edit checks, discrepancy management, database lock and archival.
- Single / Multi‑Site Management
- Trials can be managed across multiple geographic sites.
- Graphical Subject Data Entry Status
- Visual dashboards to see which subjects are complete/in progress.
- Complete Audit Trail & Auto Medical Coding
- Full traceability plus automatic mapping of medical terms.
- Regulatory Compliance
- Adheres to FDA 21 CFR Part 11, GAMP 5, ICH‑GCP.
- Univariate & Multivariate Edit Checks
- Both single‑variable and cross‑variable validations.
- Hybrid Studies Support
- Accepts both paper CRFs and eCRFs.
- Single / Double Data Entry
- Option to use either or both for data entry to enhance accuracy.
Additional features
- eCRF Design Without Programming
- Users can design forms without needing programming knowledge.
- Reusable CRFs
- CRFs can be reused across events or studies.
- Protocol Amendments & Versioning
- Manage CRF version changes and migrate existing data.
- On‑Demand Ad‑Hoc Reporting & Data Export
- Export to SAS, CDISC, CSV, XML, Excel.
- Quick Deployment
- Available hosted or on‑premise; shared or dedicated hosting; rapid implementation.
- Integration with Third‑Party Systems
- Works with IWRS, CTMS, ePRO, drug safety systems, etc.
- Integrated Data Management Services
- DDi also offers full CDM/EDC services.
- Cost‑Effectiveness
- Low total cost of ownership; minimal programming/technical knowledge required.
Pricing
Countries & Languages
Interface languages
Billing currencies
No reviews yet
Be the first to drop a review
Alternatives to DDi-mEDC
Clear Clinica
Clear Clinica is a healthcare management software platform from Clear Clinica that supports clinical trial…
ClinicalHawk EDC
ClinicalHawk EDC is an electronic data capture software from ClinicalHawk that supports clinical trial data…
Ennov EDC
Ennov EDC is a clinical data management software from Ennov that simplifies data management in…
B2W Inform
B2W Inform is a data management software from Trimble that captures rich data and improves…
About DDi-mEDC
DDi-mEDC is a data management software from Makro Care that is designed for electronic data capture and management in clinical trials. It provides features such as real-time data monitoring, secure data storage, and compliance tracking so organizations can effectively manage clinical data. The software helps facilitate regulatory compliance and improves data accuracy through automated processes. DDi-mEDC supports integration with various clinical systems, enabling efficient data flow and reporting. Key capabilities: real-time data monitoring secure data storage compliance tracking automated reporting system integration Best for: clinical researchers and organizations that need to manage and analyze clinical trial data efficiently.
DDi-mEDC Details
DDi-mEDC's In-App Market Place
Does DDi-mEDC have an in-app market place?
Yes
How many Mini-Apps in the marketplace?
1
Mini Apps
N/A
Pricing Options
Accepted Payment Currencies
USD ($), EUR (€), GBP (£), JPY (¥), AUD (A$), CAD (C$), CNY (¥), INR (₹), RUB (₽)
Pros & Cons
- Reduces data cleaning time through strong edit checks and auto coding.
- Allows quick response to protocol amendments with versioning and data migration.
- Supports both paper and electronic CRFs, offering flexibility.
- On‑demand reporting and exports to multiple formats aid decision‑making.
- Lower cost and fast deployment compared to many full‑scale EDC/CDMS tools.
- Some advanced integrations with external systems may require custom work.
- User interface & user experience details are shallow in available materials.
- May lack some highly specialized features that large CROs or pharma vendors expect.
- Training or domain expertise might still be needed to use all capabilities optimally.
DDi-mEDC's Support Options
Email Address
DDi@makrocare.comContact
(888) 931 0060DDi-mEDC's Alternatives
Clear Clinica
Clear Clinica is a healthcare management software platform from Clear Clinica that supports clinical trial…
ClinicalHawk EDC
ClinicalHawk EDC is an electronic data capture software from ClinicalHawk that supports clinical trial data…
Ennov EDC
Ennov EDC is a clinical data management software from Ennov that simplifies data management in…
B2W Inform
B2W Inform is a data management software from Trimble that captures rich data and improves…
