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Data Management (DM), Electronic Data Capture (EDC) and Statistics



Data Management



We can provide full data management services for any kind of studies. We can offer both, electronic data capture as well as paper based systems, also accelerated by fax systems.

Any system will include:

  • Study specific databases
  • Creation of data capture forms
  • Option for double data entry
  • Generation of queries
  • Full audit trail
  • Data management plan and report
  • Data listing
  • Any formats for data transfer

Electronic Data Capture (EDC)



We have experience with the use of a variety of different EDC systems. However, our preferred system is Studybase®, that was specifically developed for animal health and is fit for use in studies in pets and food producing animals.
 

  • Programming of study specific databases according to protocol requirements
  • Individual access via password identification for each person involved
  • Allocation to treatment and blinding
  • Allocation of the different roles to individual persons
  • Allocation of the language to each person
  • On-line information system
  • On line plausibilities and queries
  • Full audit trail
  • On line reports for tracking for study management, if applicable
  • Full back up and validation of the system
  • Preparation time <4 weeks from end of protocol to being on line

Studybase® has been used since 2008 in many studies that have passed regulatory approval. A variety of audits by quality assurance of multinational companies have approved it for use. The system has been used in up to 45 centres in studies involving up to 5 different countries.
 

Our animal health dedicated system is open for use in single studies. We can also offer specific offers for the use of the software in-house at your facilities as well as potentially installing the software at your in-house servers.






 



Contact Person


Dr. med. vet. Brigitte Steiner Send an E-Mail

Dr. med. vet. Brigitte Steiner

Head of Data Management, Statistics, EDC Solutions and IT Services


Statistics



We provide full statistical support to our clients related to their studies. We use different commercial software packages normally including SAS current software versions for the analysis
 

  • Development of statistical plan
  • Calculation of replicate numbers
  • Randomisation
  • Non-inferiority analyses
  • Justification of non-inferiority margins
  • Superiority analyses
  • Statistical report
  • Support during the registration process