Data management
Data management in clinical trials is the collection, consolidation and validation of all clinical trial data. The quality of clinical trial data is of paramount importance because it determines the validity of data for
We offer a full range of data management services:
- coordination of the research protocol with the data management team
- development of both electronic and paper individual registration cards (eIRC, IRC)
- creation of an electronic Data Capture system, including programming of automatic and manual checks and masks
- preparation of a Data processing Plan (Data Management Plan)
- drawing up a Data Validation Plan (Data Validation Plan)
- entering information into an electronic database from paper IRCs with two independent inputs
- conducting trainings on filling out and maintaining eIRC
- support for EDC system users
- downloading data from external sources
- constant quality control of the entered data
- preparing the database for intermediate and final closure (Database Lock)
- writing a report on data processing
- uploading data in various formats, depending on customer requirements
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Elaboration of data management plan
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Development of the template for case report form (CRF)
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Working out of the electronic CRF design and preparation of its user manual
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Organization of electronic CRF testing
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Technical support of projects throughout the clinical trial
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Creation and tracing of data clarification requests
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Control of authenticity and completeness of data at/in all steps
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Final exporting of clinical trial database
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...