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Biometry/Medical Writing
In an activity sector ever-increasingly regulated and systemized, we find it somewhat challenging to present our own competitive advantages. We believe, however, in a number of compelling values which we feel important to affirm... Here are a few:
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We never subcontract the data entry procedure in order to retain complete control over this process |
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Although we always carry out rigorous double data entries, we find it crucial not to leave anything to chance: this is why we systematically carry out an audit on double data entries, the verification of the main criterion and adverse events for 100% of the case report forms, as well as a coherence control between the plain text data entries of adverse events and the final wording obtained using international coding |
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The key to a successful statistical analysis is thorough preparation: This is why, before starting any statistical work, we always draw up a detailed Plan of Statistical Analysis (populations to be analysed, statistical tests and models to be used, means of expression of the variables, suggested tabular forms for the statistics,...) which we then submit to the Sponsor for approval |
We offer the following Biometry services:
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Consultancy in statistical methodology: definition of the experimental plan, validation of the assessment criteria, determination of the sample size, setting up the randomisation |
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Data entry (independent double data entry), coding (international classifications) and data Quality Control (double data entry control and database audit) |
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Data Management: automated correction requests, audit trail of data modifications |
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Statistical analysis (SAS software program): exploratory and confirmatory analyses, meta-analyses |
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Import and Integration of external data under any format |
We can also undertake the compilation in several languages of the following documents:
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Reports: Statistical, Clinical and integrated within the ICH format |
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Expert's reports |
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Therapeutic memos and notes |
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Investigator brochures |
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Supports for medical communication: press articles, abstracts, posters |
ON-LINE STUDIES