Statistics and Data Management Unit

Data Management and Statistics are a fundamental part of any clinical study. A good statistical result is not understood without a good data management. That is why participating from the beginning of the study and contributing in the design, data collection and in obtaining results, is fundamental.

Team work is one of our strengths, the understanding between data manager, statistician, sponsor and investigator is essential to achieve the success of the study.

We have highly qualified staff  with a long career in data management and statistical analysis in various areas (oncology, pulmonology, autoimmune diseases, etc.). The ability to communicate with our client leads to a fluent statistician-investigator relationship, enabling an efficient and reliable work and always meeting the established deadlines.

Statistics and Data Management Unit expressed in figures, since 2013

eCRFs designed

Variables managed in each eCRF on average

Patients managed in each eCRF on average

Statistical analyses of clinical studies

Statistical analysis for publications

Methodology

  • We offer statistical support in the draft of the study protocol.
  • We perform the electronic Case Report Form (eCRF) design based on the study objectives and the information required in the protocol.
  • We perform the database management during the  study, from entry of the first patient to database lock. The drafting of the Data Management Plan (DMP) allows us to establish from the beginning the strategy to be followed during the review.
  • The periodic and centralized data monitoring allows us to detect systematic errors, as well as to evaluate and prevent the associated risks.
  • We deliver queries to the sites in order to resolve the discrepancies detected in each review. Our objective is to obtain a clean database to ensure reliable and accurate statistical results.
  • Upon  database lock, our department proceeds with the statistical analysis following the guidelines established in the Statistical Analysis Plan (SAP) and always meeting the deadlines agreed with the client.
  • Likewise, we perform statistical analyses for conferences  throughout the study, giving support in the presentations (abstracts, posters, etc.) and maintaining constant communication with our client.
  • The primary objective of the Statistics and Data Management unit is to provide excellent quality in data and consequently in the study results.

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