An “EDC System” enabling greater efficiency in Trial operations

XClinical’s Electronic Data Capture (EDC) system, MARVIN, is a robust web-based EDC system which has been used to collect and process data from over 100,000 patients in more than 100 studies including clinical trials, post-marketing surveillance, registries, etc., around the world.

The multilingual feature of MARVIN allows its use in multinational clinical trials. It is the first EDC application that received CDISC ODM certification. Its competitive advantages are quick setup and reasonable cost. MARVIN, of course, is fully compliant with 21 CFR Part 11 and ICH-GCP.

MARVIN, is an EDC system that also provides double data entry and reporting functions, that meets the needs of every user engaged in clinical trials including pharmaceutical and device companies, physicians and scientists.

We have experience using many EDC systems based on sponsors’ requests.

Clinical Data Interchange Standards Consortium (CDISC):

CDISC is a non-profit organization whose mission is to develop industry standards to support electronic capture, interchange, application and storage of clinical trial data and metadata in medical care and development of medical products.

Operational Data Model (ODM):

ODM is a vendor neutral, platform independent format for interchange and archive of clinical study data. The model includes the clinical data along with its associated metadata, administrative data, reference data and audit information.

System architecture

GCP-EDC

Service line-up

  • Consultation on EDC setup
    1. Support for preparing SOPs
    2. Consultation on CSV
  • Design, development and operation
    1. Design and create eCRF screen
    2. Design data validation specifications and create logical check
    3. Prepare data entry manual
    4. User training
    5. Initial site and user management
    6. Progress and status management
    7. Implementation of manual check
    8. Query management (creation, issue and data lock)
    9. External data import and export