Clinical Data Management
Clinical Data Management Services Focusing on the Accuracy of Your Clinical Data
WHEN IT COMES TO CLINICAL TRIAL SUCCESS, DATA INTEGRITY IS KEY!
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.
END-TO-END CLINICAL DATA MANAGEMENT SUPPORT:
Using regulatory-compliant data management tools IDDI provides end-to-end clinical data management support from database set-up, through cleaning and reporting, to database lock.
CONVERSION OF DATA TO CDISC SDTM STANDARDS:
As CDISC Registered Solutions Provider we provide professional expertise for the conversion of clinical data to CDISC SDTM standards.
Our Coder, ID-Code, is a web-based tool to classify safety-related data such as adverse events or concomitant medications – and supports standard MedDRA and WHODrug dictionaries.
End-to-End Comprehensive Clinical Data Management Services
CLINICAL DATA MANAGEMENT SERVICES
- 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
- 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
Experienced Clinical Data Managers
- 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.
- Our SDTM experts have the ability and experience in developing eCRF’s to CDASH standards and delivering data in STDM standards
- Our team of data managers are committed to upholding a standardized, process-driven approach delivering timely, accurate and quality data.
“IDDI has performed data management for our 2 phase I/II trials and I am very happy of this collaboration. Everyone at IDDI was very responsive and professional. Flexibility is a great asset of the team!”
Gaëlle Charier, Clinical Project Leader, Molecular Partners AG, Switzerland
LISTEN TO PODCAST
This session is focusing on the key clinical trial services of data management & biostatistics, and considerations for why there is increased value in having both of these services delivered by the same CRO.