ClinPharmDevelopment

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Post-registration studies

Post-registration studies

The today’s drug regulation systems of developed countries strive for continuous post-marketing evaluation of drug efficacy and safety with elaboration of various risk management programs. Such programs combine post-marketing drug safety and efficacy profile studies (by observational, retrospective studies, maintaining registers, active monitoring) and the measures aimed at prevention of excessive drug therapy (risk mitigation tools).

Assistance in organization of this phase trials will be of particular interest for the manufactures of drugs long being on the market, to support rationality of their use, and thus confirm clinical reasonability of drug usage, which is the key success factor of future circulation in the pharmaceutical market.

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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."

Own highly specialized licensed software that meets E2B ICH standards and regulatory requirements of the Russian Federation, EAEU and CIS

Compliant with E2B ICH standards and regulatory requirements of the Russian Federation, the EAEU and the CIS

Fruitful cooperation with Roszdravnadzor in the field of drug safety monitoring

Performing the function of collecting and processing spontaneous messages

An effective document management system

Completeness, accuracy, data integrity, an organized set of measures to ensure the security of information storage and its confidentiality

2,000+ analyzed cases of adverse reactions

Formed own database of 300+ drugs

Timely informing the customer and regulators

A phase I study of an innovative drug used in the treatment of patients with a new coronavirus infection (COVID-19) has been completed. The final report has been prepared.

CPD has developed a strategy for preclinical and clinical study of a new prolonged finished dosage form in order to further obtain a registration certificate.

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,...

The phase III study has been completed and the final report of the study on the evaluation of the efficacy and safety of the drug used in the treatment of attention deficit hyperactivity disorder (ADHD) has been prepared in children 6-12 years of age with different dosage regimens.

The SRV organized three studies of user testing of the text of the instructions for medical use (leaflet) of the medicinal product for medical use.

CPD has received permission from the Russian Ministry of Health to conduct a phase III clinical trial of a promising broad-spectrum drug used in the treatment of patients with a new coronavirus infection (COVID-19) severe course and proceeds to organize the conduct of this study. Up to 350 patients ...

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...

A protocol has been prepared for conducting a phase II comparative study of the efficacy and safety of different dosages of the drug in sequential therapy in patients with primary open-angle glaucoma.

CPD provided services under the contract for the preparation of the registration dossier for the original drug.

CPD has started developing a Phase 3 protocol for the study of reproduced drugs used for non-inhalation anesthesia.

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...

CPD has started a phase I clinical trial of an innovative drug — human immunoglobulin containing antibodies against SARS-CoV-2.

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...

CPD has received permission and is starting to conduct the clinical part of the bioequivalence study of a foreign drug used in the treatment of dementia syndrome of various origins, including Alzheimer's disease, ischemic stroke.

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