PharmaPro Consulting’s expert biostatisticians with wide industry experience will help you apply statistical and scientific principles to select the optimal study design, randomization, endpoints, sample size, and analyses to accelerate the clinical development program for your compounds.
Our consultancy services include:
· Independent verification of study design, sample size, and endpoints
· Independent review of analysis plans and validate the sufficiency of analysis
· Perform sensitivity analyses to test the robustness of results
· Assist in regulatory strategy planning, regulatory questions, and meetings
· Our programming expertise will enable you to transform your analysis needs to modular code that arrives at the right results quickly and consistently with high traceability.
In addition, we can consult on the following services:
o Regulatory compliance evaluation of clinical trial data
o Verification of adherence to industry data standards (CDISC SDTM/ADaM, SEND)
o Verification of M5 data submission package
o Optimizing programming process in existing teams/environment
o Data Standards Gap Analysis
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