Statistical Analysis and Data Management
for Clinical Studies
Services
Data Management
Epidemiology and Study Design
Biostatistics
StatistX offers a complete service of data management services with compliance to the ICH GCP and part 11 of title 21 of the Code of Federal Regulations (21 CFR part 11).
Our services in data management are:
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Data entry and double data entry from paper CRF
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Data capture using EDC (eCRF) – Building the data entry systems, and providing assistance to sites and monitors.
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Producing Data Management Plan documents (DMP)
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Simple and stratified randomization of subjects
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Programing automatic queries and logical edit checks
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Coding of adverse events using the Meddra Dictionary
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Coding of Medications using the WHO dictionary
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Quality Assurance (QA)
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Database lock
StatistX offers epidemiology and study design counseling for improving the odd for a successful trial. Using the proper study design and selecting the right set of study outcomes can be crucial. Sample size calculations based on the primary outcome, using the most appropriate method based on the study parameters may assist in reaching the trial goals and saving extra costs of an oversized sample.
Our services in Epidemiology and Study design are:
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Calculating sample size and simulations of sample size/power ratio.
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Counseling on study design characteristics such as number of arms, randomization design and analysis populations.
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Producing Statistical Analysis Plan (SAP)
We at StatistX believe that producing a statistical report from raw databases in much like sculpting a beautiful statue out of a raw rock. The shape of the study result is hidden in the numbers, and the artist statistician needs to show the truth behind the numbers. We believe in integrity and straight forwardness regarding the results, and are working hard for every client to get the best possible service that we can give.
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Building summary tables and individual listings
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Analyzing study endpoints according to the protocol and SAP
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Post-hoc analyses counseling
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Pharmacokinetics analyses (PK)
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Pharmacodynamics analysis (PD)
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Cross-Validation checks for data consistency
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Academic research assistance for faculty and students
About Us
At StatistX we take pride in creating a healthy organizational culture. We strive to always learn and improve our knowledge, to always provide best in breed solutions.
Our staff includes senior biostatisticians and epidemiologists, experienced field medical staff, trained clinical trials monitors, and excellent data management programmers. Our staff is well versed in various academic fields, including Epidemiology, Public Health, Nursing, Psychology, and Psychiatry.
