Statistical processing of clinical trial results
One of the key tools used in clinical research is biostatistics. Biostatistics methods are used both at the research planning stage and when processing data arrays obtained during the study.
We will help in choosing the endpoints of the study, substantiating the required size of the patient/volunteer group, as well as selecting the correct statistical methods for analyzing the parameters of the efficacy and safety of the drug under study. Also, statisticians of our organization conduct final statistical analyses of data obtained during clinical and preclinical studies, as well as form a final report on the results of clinical trials.
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Statistical planning of clinical trials
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Determination of the necessary statistic parameters on the step of clinical trail design
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Calculation of the needed number of patients
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Control of completeness and authenticity of clinical trial data
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Checking of arrays of the data collected, correction of mistakes in bases
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Statistical processing and analysis of clinical trail data
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Calculation of statistical parameters, preparation of statistical reports
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Consulting on statistical data processing
ClinPharmDevelopment
Is an independent contract research organization successfully implementing preparation for and carrying out of clinical trials of all phases within the territory of Russia and EAEU countries.
We employ more than 30 people, including 6 PhD degree holders. All employees involved in trials have a university degree in medicine or pharmacy, GCP/GLP certificates, and broad experience of participating in clinical trials.
The company successfully cooperates with the centers of the Russian Federation for preclinical research that meet all modern requirements, localized in Moscow, St. Petersburg, Yaroslavl."
CPD has received permission from the Ministry of Health of Russia and is starting to conduct the clinical part of the bioequivalence study of a drug used in the treatment of inflammatory and degenerative diseases of the musculoskeletal system, pain syndrome from the spine (lumbago, neuralgia, myalgia,...
CPD employees have prepared a number of protocols and related documents for obtaining permission from the Ministry of Health of the Russian Federation to conduct bioequivalence studies of medicines.
Studies of a nootropic drug used in the treatment of diseases of the central nervous system...CPD has received permission from the Ministry of Health of Russia to conduct bioequivalence studies of a series of drugs.
Medications for the treatment of benign prostatic hyperplasia (dual 5α-reductase inhibitor) for the treatment of benign prostatic hyperplasia, treatment of dysuric disorders...CPD employees have prepared a number of protocols and other documents necessary to obtain permission from the Ministry of Health of the Russian Federation to conduct drug research.
Clinical studies Phase I of the original preparation of the Russian manufacturer, which has pronounced sorption...
A series of reports on completed clinical trials of bioequivalence of drugs was prepared in a short time.
Drugs highly selective direct factor Xa inhibitor, two dosages; contraceptive combination drug (two studies); an antidepressant used in the treatment and prevention of depression...The report of the phase III study of the Russian drug for the treatment of patients with COVID-19 was prepared and finalized in a short time.
This drug is intended for the treatment of a wide range of viral infections and is a purine nucleoside that acts as a competitive inhibitor of viral ...
CPD has prepared a protocol for a phase 3 study of a promising broad-spectrum drug used in the treatment of patients with coronavirus infection (COVID-19) of moderate and severe forms as part of standard therapy.
After the approval of the Ministry of Health of the Russian Federation, CPD will...
The recruitment of patients to phase III studies of a Russian drug for the treatment of patients with COVID-19 has been completed ahead of schedule.
This drug is intended for the treatment of a wide range of viral infections and is a purine nucleoside that acts as a competitive inhibitor of...