IDDI offers a clinical data management system from XClinical (MARVIN), allowing for paper and electronic CRF data capture simultaneously.
The system allows interactive double data entry of paper CRFs by IDDI data entry operators, ongoing throughout the study, as well as EDC. MARVIN is ODM certified by CDISC.
Patient data are collected at the investigational sites throughout the duration of the trial. Such Data collection can be done from paper (on Case Report Forms) or electronically (either on electronic Case Report Forms or through remote data capture).
Data are checked, validated and coded before they are used in the statistical analysis.
Monitoring visits and on-site audits guarantee that the data collected reflect the source data and provide an accurate summary of the patient condition.
Adverse events, and particularly serious adverse events, must be reported within pre-specified time limits.
IDDI is not involved in clinical operations monitoring nor in safety data collection and reporting.
Patient profiles and Internet reports are typically produced to help the trial Sponsor monitor the progress of the trial.
Most of IDDI's data management staff has been with IDDI for at least 4 years.
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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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 Summares