biostatistics

The ClinDatrix biostatisticians and biostatistical programmers provide a full range of biostatistical services including sample size calculations, randomization schedule generation, blinding and unblinding procedures, statistical analysis plans and statistical analyses.

Sample Size Calculations

The calculation of an adequate sample size is crucial in any clinical study and is the process that determines the optimum number of participants required to arrive at ethically and scientifically valid results. ClinDatrix uses our statistical expertise to generate sample size calculations for clinical investigations for any phase of the drug or device development cycle.

Randomization

In clinical trials, randomization helps prevent bias in subject allocation, produces treatment groups that are similar in known and unknown demographic and prognostic factors, and provides a sound statistical basis for data analysis. ClinDatrix produces randomization schedules based on the protocol design utilizing SAS Software.

Clinical Trial Design

To best assist our clients in clinical trial design, ClinDatrix involves our biostatisticians at the earliest stages. These professionals provide expertise in the experimental design, the size of the clinical trial and measures to make optimal use of limited resources. Their expertise in adaptive designs, interim analyses, randomizations, analysis methods, p-values and more can be leveraged by our clients toward efficient trial design.

CRF/eCRF Design

In designing our clients’ CRFs/eCRFs, ClinDatrix calls on a strong cross-functional team that includes Clinical, Medical Safety, Data Management and Biostatistics personnel. Our teams incorporate database design, ease of data entry and statistical output considerations while creating each CRF/eCRF, regardless of the phase of the drug or device development cycle or the therapeutic indication.

Statistical Analysis Plan

ClinDatrix prepares a complete statistical analysis plan that includes a detailed description of all patient populations and statistical analyses to be carried out on the data collected during the clinical investigation. Mock-ups of tables, listings and figures (graphs) also are part of the statistical analysis plan.

Project Specific Documentation

ClinDatrix follows our standard operating procedures for any statistical services provided to our clients. As required, we work in conjunction with our clients to prepare protocol specific procedures.

Patient Evaluability

Prior to unblinding a blinded clinical trial and prior to the commencement of the analyses of data from a blinded clinical investigation, ClinDatrix works in concert with our clients to determine and finalize the patient evaluability rules based on the clinical protocol.

Statistical Programming

ClinDatrix subjects all statistical programs to validation prior to delivering statistical tables, listings and/or figures (graphs) to clients. Validation is confirmed through independent review of programming code by a statistical programmer or statistician different from the one who generated the original programs or through an independent generation of statistical programming code by a different statistical programmer or statistician.

Statistical Tables, Listings and Graphs - CDISC

Statistical tables, listings and graphs are generated by ClinDatrix according to the statistical analysis plan and to the statistical section of the protocol. Any differences between the statistical analysis plan and/or the statistical section of the protocol is detailed in the statistical and/or clinical report. Statistical programs to produce tables, listings and graphs use the CDISC standards for generating SDTM and ADaM datasets.

Statistical Report

We produce a statistical report in conjunction with the preparation of a full clinical report. The statistical report provides a description of the findings of the statistical analyses for the clinical investigation and confirms that the analyses were conducted per the statistical analysis plan. Deviations from the statistical analysis plan or additional unplanned analyses are fully described in the statistical report.

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