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SGS’ Data Management team has over 15 years of experience providing unparalleled service with an understanding for individual clients’ needs. Clients benefit from SGS’ commitment to meeting project timelines, without compromising quality or integrity. Data Managers play a key role in each trial at SGS from the very beginning, from designing the Case Report Form (CRF) to providing input on key project documents.
As one of the largest independent teams in Europe with over 130 professional staff, SGS' experienced Biometrics department (data management/ statistics/ medical writing) supports all in-house and external project needs for clinical trials. SGS is fully equipped to handle all data management requirements for the full duration of a drug’s development.
Data Management Services:
- Review & input on protocol design
- CRF design & review
- Database design according to client’s specifications
- Independent double data entry of hard copy CRFs
- Electronic Data Capture (EDC)
- Electronic tracking of CRFs and Data Queries
- Thorough data review using validated electronic checks, data listings, and manual checks
- Coding according standard coding conventions, as specified by the sponsor, under supervision of a physician – MedDRA, WHODRUG, ICD-10
CDISC: Clinical Data Interchange Standards Consortium:
- SGS has adopted a proactive strategy in applying the CDISC standards to clinical trials. SGS developed its own implementation guide for SDS 3.1, and has already delivered more than 30 trials in the SDS structure.
- In addition, SGS has converted more than 100 trials to the SDS structure for submission to the FDA. SGS can provide SDTM 3.1 and Analysis Dataset Model (ADaM).
21CFR Part 11 Compliant
The Data Management department uses a fully validated data management software package for data entry with electronic audit trailing, validated checks, and auto-encoding. This software package allows data reviewers to perform consistency checks, reporting and formatting.
Clinical Data Management Systems:
- Oracle 9i environment
- Clintrial® v 4.4
- InFormTM v 4.5
- Clintrial® Integration System 4.0 Sp 4B
- Oracle Clinical® v 4.5
- SAS® 9.1
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