Product/Service

Biometrics

Source: SGS Life Sciences Services
SGS's Data Management team has over 15 years of experience providing unparalleled service with an understanding for individual clients' needs.

SGS's 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 135 professional staff, our 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, or simply an overflow in capacity for individual trials.

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

Within the past five years, SGS has performed 20 EDC projects, involving over 10,000 subjects.

SGS works closely with several EDC companies, supporting web-based applications. Most recently, SGS has formalized a strategic partnership with Phase Forward for use of their InForm™ EDC solution. SGS has extensive experience with the InForm™ and this agreement allows SGS to offer the EDC system as an integral part of the SGS solution set. Clients benefit from SGS' experience and seamless relationship with Phase Forward for EDC trials.

More information on the collaboration with Phase Forward and other SGS partnerships.

  • 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 SDS 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.

Oracle 9i environment

Clinical Data Management Systems

  • Clintrial® v 4.4
  • InFormT™ v 4.5
  • Clintrial® Integration System 4.0 Sp 4B
  • Oracle Clinical® v 4.5
  • SAS® 8.2