Clinical monitoring
Monitoring of clinical trials is the process of monitoring the progress of a clinical trial, designed to ensure that it is conducted, documented and information about it is transmitted to the appropriate authorities in accordance with the Protocol, GCP rules, standard operating procedures and requirements of official authorities.
As part of the project monitoring services, the CRO CPD team assumes the following functions:
- Conducting monitoring visits: selection visits, clinical center openings, routine and remote visits, clinical center closure visits
- Monitoring the availability of all necessary notifications/approvals of local ethical committees of organizations
- Verification of receipt, storage and delivery of the studied drug, biomedical cell product and reference drug
- Inventory accounting of research materials
- Control of patient enrollment in the study
- Confirmation of procedures for obtaining informed consent of patients
- Monitoring compliance with the protection of the rights and interests of research subjects
- Control of the correctness of the randomization procedure
- Control of proper storage and maintenance of research documents
- Monitoring of registration of adverse events
- Monitoring and timely reporting of NYA/NYA/pregnancy cases and deviations from the protocol
- Monitoring compliance with applicable regulatory requirements and protocol requirements
- Checking the correctness of the primary documentation
- Verification of data transfer to individual registration cards (IRC)
- Control over the preparation of documents for archiving
Preparation of reports on conducted visits
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Monitoring visits: center opening visits, routine and remote visits, center closing visits
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Control of availability of all necessary notifications/approvals from the local ethics committee
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Check of receipt, storage, and issuance of the investigational drug/reference drug
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Inventory accounting for clinical trial materials
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Control of patients enrollment in a trial
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Confirmation of the procedures of obtaining informed consent forms from patients
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Control of proper randomization
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Control of duly storage and maintenance of trial documents
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Monitoring of adverse events registration
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Tracing and timely reporting about SAE/pregnancy and deviations from the protocol
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Control of compliance with effective regulatory requirements and requirements of the protocol
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Check of trial raw documentation (hospital records, etc.)
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Check of data transfer to case report forms
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Control of documents preparation for archiving
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Elaboration of visit reports
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...