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!
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.
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.
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.
With one single software solution, we deliver everything from eCRF implementation to clinical database oversight in all therapeutic areas.
EDC SET UP :
Set up in IDDI’s system ID-base (Marvin powered by EvidentIQ) or Rave (powered by Medidata). Intuitive Electronic Data Capture (EDC) systems integrated with IDDI RTSM System.
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.
MEDICAL CODING:
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.
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
End-to-End Comprehensive Clinical Data Management Services
- EDC set-up via ID-base™ powered by EvidentIQ or Rave powered by Medidata
- eCRF design
- Automatic edit checks
- Reporting
- Online Patient Profile
- CDASH compliancy
- Data export to SAS according to CDISC SDTM standards (Pinnacle 21, DefineXML, Reviewer Guidelines)
- Advanced Edit checks
- SAS Listings
- Patient Profile
- Data Review
- External data import & reconciliation (SAS and/or EDC)
- Medical coding (MedDRA, WHODrug)
- Pooling of databases for registration purposes
- Consultancy
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.
LISTEN TO PODCAST
BIOSTATISTICS AND DATA MANAGEMENT:
COMBINED SERVICES ENSURING YOU MEET YOUR STUDY GOALS!
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.