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› Data Management

A perfectly well codified and documented methodology from specification to final archiving. Our Data Management Department in relation with the Project Manager will offer the most adapted solutions to your study : electronic data collection or traditional paper forms or both.

Our coding system, adaptable to any standard dictionary (MedDra, Who Drug) allows an evolutive process until the data base is locked.

Possible conversion of original clinical databases into CDISC SDTM standard and Database lock (in SAS® format or other).

Electronic process :

  • For electronic process, our multilingual electronic case report form (eCRF) is built on more than two decades of experience with databases dedicated to clinical trials. The robustness of the concepts and the data structures we use were validated by several dozen studies. The integrated procedures in production, development, test and maintenance were thoroughly audited and fully documented in compliance with CFR 21, Part 11. Checks for occurrence, probability, and coherence are made simultaneously with, or as quickly as possible after, data entry for complex controls. The investigator is warned of any errors detected and can take action immediately. In addition, the coordination centre can follow the quality of the data input in real time. Management monitoring follows the same process. On-site audit of forms can be done on line. Each modification is made by clicking on the item, which generates a change that the investigator validates electronically.

Paper process :

  • For paper process, the data treatment channel allows a real time data exploitation :
    • Reception and recording: as soon as they are received, study forms are recorded in the study database,
    • Control of patients’ identification: immediate detection of patients’ forms not adequately identified and of study calendar deviations,
    • Data entry: double independent data entry, systematically doubled for discrepant data (error rate < 1/1000),
    • Data control: presence, likelihood and coherence of data are automatically checked. All corrections are documented and listed,
    • Follow-up status: synthetic or detailed follow-up status provide you with day to day updates of study progress. Follow-up status are accessible on line via the Internet®.

› Biostatistics

Before the study starts, our Statistics Department is implicated in the preliminary choices :

  • Study design: parallel, factorial, cross-over, Latin square, case control, cohort studies…,
  • Hypotheses: difference, non-inferiority, equivalence, one- or two-sided…,
  • Sample-size calculations,
  • Overall or stratified randomization

During the study / at the end of the study : our Statistics Department plans and programs the study analysis on the SAS® system and then writes up the clinical and statistical report in collaboration with the Study Manager (in agreement with the guidelines ICH E3 and ICH E9) :

  • Writing of the Statistical Analysis Plan
  • Importation or exportation of data in a SAS® format or other formats,
  • Programming of analysis data sets (ADAM standard or other)
  • Dry run editions
  • Integration and control of the randomization list,
  • Use of adequate methodology, from the most simple to the most sophisticated: parametric or non parametric tests, analyses of variance, survival analyses, logistic regression…,
  • Either ICH report or reports written in compliance with your procedures.