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Clinical trials

BridgePharm company to provide services of high quality on carrying out all phases of clinical trials (I-IV) of medicines on favorable terms.

Successful cooperation with medical institutions and investigators with significant experience in different nosology groups allows to quickly select the most suitable clinical sites for the most complex research activities.

Early-phase (I, II) clinical trials

Company BridgePharm has experience in conducting early-phase (I, II) clinical trials within the process of the drug registration, or as a part of the drug research process.

 

Phase I

A study carried out in a small group (5-50 people) of healthy volunteers or patients with certain disorders or diseases.

In this phase assessed are the drug's safety or the proposed treatment regimen. These studies are "open," meaning that information about medications (dosages, treatment regimens), that receive study subjects is available to doctors and subjects.

Phase I studies may also be required as a part of registration program even for well-known products (e.g. in case of new or modified dosage form, etc.)

 

Phase II

A study carried out in a larger group of patients (100-300 people) with certain disorders or diseases. In this phase assessed are efficacy, the selection of regimen dose in terms of efficiency and the risks of use. In this phase the study is also usually "open".

 

Phase III clinical trials

Testing with large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.

We have significant experience in both international multicenter phase III studies of high quality and local registration time- and cost-effective phase III studies.

Bioequivalence studies

BRIDGE PHARM successfully executes BE studies of generics and biosimilars at sites located in Moscow, St. Petersburg, Smolensk and other Russian cities with more than 250 volunteers involved.

BRIDGE PHARM cooperates with 6 clinical sites and 3 bioanalytical labs eligible to appropriately conduct BE studies.

Our clinical and bioanalytical activities are performed according to SOPs that were successfully audited by international pharma companies.

Experienced specialists of our company to effectively perform the following activities:

Medical Writing

·        Development of the bioequivalence study protocol

·        Development of accompanying documentation: CRF, informed consent form, investigator brochure 

·        Statistical analysis and preparation of the report

 

Clinical Operations 

·        Clinical site selection 

·        Insurance of volunteers participating in the trial

·        Obtaining permission from MoH 

·        Clinical monitoring and auditing

 

Bioanalytics

Own bioanalytical laboratory undergone various audits

Bioequivalence studies in patients

In the case of investigation of certain drugs possessing known toxicity (e.g. cytostatics), using healthy volunteers as subjects is unethical.

Our experts have considerable experience in conducting studies in patients with certain medical conditions, protocol negotiation with the ethical committees and pharmacovigilance in such studies.

Studies in special populations

Clinical studies in specific populations refer to the studies involving patients belonging to vulnerable groups such as children, people with mental illness, patients who cannot read the information and sign a consent form (e.g. unconscious), and other, ensuring of the rights of which during the trial needs some additional control.

For clinical studies in specific populations we pay particular attention to the protocol development (especially the informed consent procedures), consultancies with the ethics committees, ensuring appropriate monitoring.

Post-marketing studies

Successful cooperation with medical institutions and investigators with significant experience in different nosology groups allows to quickly select the most suitable clinical sites for the most complex research activities.

Phase IV studies are required for:

·        improvement of dosage regimens of the drug;

·        studies of interaction with other medicines;

·        comparative analysis with other standard medications;

·        application of the medicine in other age groups, or other categories of patients;

·        the impact of long-term effects of the drug on survival (reduction or increase in mortality);

·        the results of long-term use in patients of different groups.

 

Development of a well-functioning framework for the timely detection of adverse reactions has certain advantages for Phase IV clinical trials.

Pharmacoeconomic studies

Company BridgePharm conduct pharmacoeconomic studies by means of different methods: mathematical modeling, retrospective analysis and others.

Our services

·        retrospective and prospective clinical trials containing elements of pharmacoeconomic analysis based on an earlier study

·        Trials, which are based on studying of data obtained during the inpatient and outpatient practice in close cooperation with leading medical institutions of the Russian Federation and the CIS

 

Trials of medical devices

The amended legislation established new requirements for clinical trials of medical devices. We offer execution of both clinical trials in the form of documents expertise and trials in patients.

Successful cooperation with medical institutions and investigators with significant experience in different nosology groups allows to quickly select the most suitable clinical sites for the most complex research activities.

Home Page Registration Preclinical studies Data management

Full name:
LLC «BRIDGE PHARM»

Adress:
119571, Moscow, Str. 26 Bakinskikh Kommisarov, 5, office 3

Details:
OGRN 1137746964630
INN 7708799217 KPP 770801001

+7 499 550 6653
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