DATA MANAGEMENT

Southern Star Research boasts a full suite of customisable Data Management and Biostatistics services, through the use of some of the most advanced systems currently on the market.

With over 10 years industry experience across our locally based team of Data Managers and Biostatisticians, has broad expertise across all study phases and many therapeutic areas. Our team is particularly adept at providing the flexibility and ingenuity needed to provide data management solutions for all phase and types of studies.

Having the end site user at the forefront of our minds, Southern Star Research’s clinical databases are programmed to have the highest levels of user friendliness, making data entry as easy as possible at site, keeping compliance strong and ensuring data entry isn’t a chore.

Key Data Management Services offered by Southern Star Research includes:

  • CRF Design
  • Database Design and Build
  • Edit Check Programming
  • Data Cleaning and Validation
  • Laboratory and Third Party Data Integration and Reconciliation
  • Medical Coding
  • Provision of CDISC compliant SDTM and ADaM datasets

Southern Star Research is happy to offer one of the industry’s most cutting edge electronic data capture (EDC) systems as our chosen database platform, IBM’s Clinical Development.

IBM® Clinical Development (Formerly MERGE eClinicalOS) is a 21 CFR Part 11 compliant, cloud based, electronic data capture (EDC) solution. Designed to be intuitive and easy to navigate, users access all study data and platform functions through a centralised, password-protected web interface. IBM® Clinical Development is a unified, cloud-based data management platform that lets you design and manage clinical trials with unparalleled control, convenience and confidence.

The fully integrated modules available within the system include:

  • Randomisation
  • Supply Management
  • ePatient Report Outcomes (ePRO)
  • Third Party Data Import
  • Medical Coding
  • End Point Adjudication
  • Risk Based Monitoring (RBM)

Southern Star Research is also proud to be fully trained and accredited by IBM® to perform all database programming activities in house, including database build for the IBM® Clinical Development system.