Clinical Data Management Services
Clinical Data Management Services Focusing on the Accuracy of Your 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. Data management is a critical phase in clinical research. IDDI is your partner for providing quality data ready for submission.
From database set-up, through cleaning and reporting, to database lock, IDDI is committed to delivering timely, accurate and quality clinical data by using regulatory-compliant data management tools. Focusing exclusively on clinical data, we are able to offer efficient and flexible clinical data management solutions.
Our team of data managers are committed to upholding a standardized, process-driven approach. 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.
End-to-End Comprehensive Clinical Data Management Services
With one single software solution, IDDI delivers everything from eCRF implementation to clinical database oversight.
- End-to-end clinical data management services (EDC system) for all clinical trial phases and all therapeutic areas.
- CDISC-compliant electronic data capture (EDC) system, ID-base from XClinical
- Our data managers are also familiar with other off-the-shelf EDC systems.
CLINICAL DATA MANAGEMENT SERVICES
Mapping into SDTM/ADaM according to CDISC terminology:
- As CDISC Registered Solutions Providers all studies are performed in compliance with FDA and CDISC requirements. To reach this goal, the database structure will be transformed into the SDTM structure together with the appropriate documentation.
- Our SDTM/ADaM experts have the ability and experience in developing eCRF’s to CDASH standards and delivering data in STDM and ADaM standards.
- Define XML
- Designing company-specific CDISC Standards
- Extensive ODM-XML knowledge
- Knowledge of the therapeutic area
- Extensive experience in CDISC SDTM and ADaM conversions and standards