Clinical Data Management

Cost-Effective Clinical Data Management Focusing on the Accuracy of Your Clinical Data

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Clinical data management is a critical phase in clinical research. IDDI is your partner for providing quality data ready for submission.

From database set-up, through cleaning and reporting, to database lock, IDDI is committed to delivering timely, accurate and quality clinical data by using regulatory-compliant data management tools. Focusing exclusively on clinical data, we are able to offer efficient and flexible clinical data management solutions suitable for biostatistical analysis.

Our team of data managers are committed to upholding a standardized, process-driven approach. All of our clinical data managers have a scientific background, they are able to deeply understand each clinical study, from database set-up to database lock. Whether you need data management as a stand-alone service, part of a full-service or full functional outsourcing, we can tailor a customized solution to meet your needs.

End-to-End Comprehensive Clinical Data Management Services

With one single software solution, IDDI delivers everything from eCRF implementation to clinical database oversight.

  • IDDI provides end-to-end clinical data management solutions (EDC clinical trials) for all clinical trial phases and all therapeutic areas.
  • IDDI uses a CDISC-compliant electronic data capture (EDC) system, ID-base from XClinical
  • Our data managers are also familiar with other off-the-shelf EDC systems.
CLINICAL DATA MANAGEMENT SERVICESADVANTAGES
  • eCRF design
  • Database definition, set-up and validation
  • Creation of data validation plan, edit check programming, testing and validation
  • CRF tracking, registration and data entry (double data entry)
  • Data review
  • Quality control
  • Real-time reports on study progression and data listings
  • External data import and reconciliation (e.g., central lab data, reading centers data, randomization data from our randomization system, ID-net)
  • Medical coding (MeDRA, WHO-DD) with IDDI’s proprietary web system: ID-codeä
  • Data export to SAS according to CDISC SDTM standards
  • Pooling of databases for registration purposes
  • EDC trials conducted with IDDI’s system or other vendors’ EDC systems
  • Key clinical data are collected (to provide biostatistics only with the critical data needed for statistical analysis).
  • Reduced EDC set-up time, therefore reduced associated costs
  • Broad experience supporting various indications and EDC systems
  • Fully integrated EDC, IWRS and medical coding
  • Robust CFR Part 11 validated web-based tools
  • Database structure based on CDISC SDTM (adaptable to any proprietary structure if necessary)
  • Efficient integration of external data (e.g., central lab, reading center, images, etc

Mapping into SDTM/ADaM according to CDISC terminology:clinical data management

  • As CDISC Registered Solutions Providers all studies are performed in compliance with FDA and CDISC requirements.  To reach this goal, the database structure will be transformed into the SDTM structure together with the appropriate documentation.
  • Our SDTM/ADaM experts have the ability and experience in developing eCRF’s to CDASH standards and delivering data in STDM and ADaM standards.

Expertise in: 

  • Define XML
  • Designing company-specific CDISC Standards
  • Extensive ODM-XML knowledge
  • Knowledge  of the therapeutic area
  • Extensive experience in CDISC SDTM and ADaM conversions and standards