IDDI uses an off-the-shelf clinical data management system MARVIN from XClinical, a CDISC compliant electronic data capture system, and Capture System from Clinsight, which allows interactive double data entry of paper CRFs by IDDI data entry operators, ongoing throughout the study.
IDDI is a CDISC Associate Member.
Data Management services provided by IDDI are:
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Create/Validate the DM section of the protocol
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CRF design or review
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CRF printing & management of printing vendor
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EDC
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Database set-up and screen design
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Data Management Plan and documentation
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Data Validation Plan, edit check programming and testing
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CRF tracking and double data entry
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Coding of medical terms via ID-code™ (using MedDRA and WHO-DD)
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Query management: data cleaning & validation
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Data listings
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Patient profiles
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SAE reconciliation
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External data import and reconciliation (e.g. central lab or reading centres ...)
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Blind review
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Quality control
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Reports & listings on study progression
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Data export to SAS®
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Database transfer and database lock
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Integrated Safety Summaries and Integrated Efficacy Summaries
Why use IDDI for data management?
- Broad experience of the team on various indications.
- Low turnover for all profiles.
- Very robust and CFR part 11 validated web based Data Management tool (EDC): - Cost efficient DM system (Capture system from Clinsight) based on Oracle for paper trials.
- Standardized database structure based on CDISC SDTM (obviously, we are flexible to adapt to any proprietary structure if necessary).
- In depth "Clinical" data review.
- Fully integrated EDC and IWRS and with IDDI's coding system (ID-code)
- Efficient integration of external data (e.g. Central Lab data, Central Reading data, Images, ...) .
- Reduced EDC development (set-up) time and therefore also reduced associated costs.
- With one single software, IDDI delivers everything from eCRF to Clinical Database.
- Extensive Training and documentation.
IDDI's Internet-based Data Management system MARVIN has been used since 2002 over 170 clinical trials, covering over 140,000 patients over 5,000 sites throughout all continents
MARVIN's DDE (Double Data Entry) system offers the following functionalities:
- Blind DDE approach with dedicated review process
- Each items allows:
- pre-defined formats
- free text and
- investigator comments - Attachable "Memos" for internal notes
- Automated and manual query workflow