Focusing on the accuracy of your clinical data, our clinical data management experts are committed to delivering timely, accurate and high quality clinical data.

• Whether you need clinical data management services as a stand-alone, part of a full-service or full functional outsourcing, we can tailor customized clinical data management services to meet your needs.

• With one single software solution, we deliver everything from eCRF implementation to clinical database oversight in all therapeutic areas.

• EDC set up via IDDI’s system ID-base (powered by XClinical or Rave (powered by Medidata)

• From database set-up, through cleaning and reporting, to database lock, IDDI is committed to delivering timely, accurate and quality data by using regulatory-compliant data management tools.

Features:

• EDC trials conducted with IDDI’s system ID-base, Medidata Rave or other vendors’ EDC systems

• 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)

• Quality control

• Medical coding (MeDRA, WHO-DD) with IDDI’s web system: ID-code

• Data export to SAS according to CDISC SDTM standards

• Pooling of databases for registration purposes

• Graphical patient profiles

Benefits:

• 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

• Real-time reports on study progression and data listings

• External data import and reconciliation from our randomization system, ID-nettm

• Support to Medical Data Review

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