Datamanagement

Our strategy

Our approach begins by building exactly the data structure our clients are used to. We use our clients current well known standard data structure when our clients says go. If the client is used to build workflow around – the CDISC SDTM and ADaM standards right from the very beginning we do just that. We are passionately committed to the CDISC standards, which are poised to become the global accepted standards for data in the same way that ICH-GCP standards govern the clinical realm. If other systems is favored we include this with our high speed client interaction. In this increasingly data-driven world, our close client relationship put our Sponsors at an immediate advantage when compared to other sourcing systems. We
have established an Indian sourcing unit in Bangalore, with a unique mix of Nordic dialogue based working tradition integrated into an Indian highly educated and effective workforce. Most foreign sourcing experiences struggles with misunderstandings in communication and working habits. Our DM unit is designed with a Nordic management and a stringent focus on our clients SOP’s and IT systems.
You will get the best of two continents. The result: an integrated datamanagement approach that maximizes program success, minimizes cost and delays, and optimizes your entire development program.

Our Data Science and Biometrics services include:
  • Database development, programming and validation
  • User administration, training and support
  • Data validation programming
  • CDISC standardization
  • Data review, query and reporting
  • Tables, figures and listings creation and validation
  • Interim and final biostatistical analysis
  • Adaptive study design
  • Data transfers and integrations