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Clinical trials of pharmaceutical products

The list of services performed by “Regapharm” experts under the Clinical Trial Agreement:
  • Preparation of clinical trial medical documentation
  • Planning and management of clinical trials
  • Analysis of information acquired in the clinical expertise process
  • Statistical data processing and information monitoring during the clinical trial
  • Logistical arrangements for the clinical trial
  • Clinical trial monitoring
  • Selection of clinical bases for clinical trial
  • Creation of the final report for the clinical trial

We offer a comprehensive solution for clinical trials:

The registration procedure is described in accordance with the Federal Law No. 61 "On the Circulation of Pharmaceuticals" with all amendments including those entered into force on January 1, 2016

Generation of essential Study documents

  • Clinical Study Protocol
  • Patient information
  • Patient Informed Consent
  • Clinical Investigation Brochure
  • Standard operation procedure
  • Drug Efficiency and Safety Review
  • Clinical Study Report
All Clinical Study Documents are prepared by the medical scientific investigation experts. All Documents are in compliance with the ICH GCP, correspond to the regulations of the FDA, EMEA, the Ministry of Health of the Russian Federation and the Federal State Institution “Scientific Center for Expertise of Medical Products of the  Ministry of Health and Social Development of the Russian Federation”. We can prepare Clinical Study Documents for the studies, conducted by us, or for individual projects.

Clinical Study Project Management

We will highlight the aspects considered as priority by “Regapharm” in this section concerning the arrangement and performance of the clinical trials. It should be noted that implementation of the “Project preparation” shall follow the trial report preparation, the review of its design, a number of patients, clinical bases and all necessary samples to be most effective. Otherwise, it would be difficult to estimate the budget and the opportunities.

Program development. Resource planning

  1. Technical and economic assessment of the Clinical Study
  2. Budget Development
  3. Selection of clinical sites
  4. Development of monitoring system
  5. Training of Investigators
  6. Contracting with study sites, researchers and third parties
  7. Research team member training
  8. Obtaining All authorization documents
  9. Coordination of Clinical Study supplies, customs processing and material shipment 

Project management

  1. Monitoring of the sponsor’s interests
  2. Efficient financial project management
  3. Clinical Study Monitoring
  4. Continuous cooperation with the sponsor
  5. Periodic reports after each phase of Clinical Study is completed
  6. Negotiation on behalf of the sponsor and project management

Project completion

  1. Data reconciliation between project team and data processing group
  2. Coordination of biological sample destruction or their transfer to the sponsor
  3. Summarizing data founded during clinical study
  4. Clinical Study Documentation archiving

Processing of data founded during clinical study

  1. CRF/Patient diary Design
  2. Programming of input data validation
  3. Import of laboratory data
  4. Adverse event coding
  5. Medical coding
  6. Case-record coding
  7. Import/Export of data
  8. Disambiguation in the reports

Statistical Analysis of Clinical Study Data

  1. Preparing the design of Clinical Study
  2. Preparing the Statistical Analysis Plan
  3. The design of tables
  4. Programming of data presentation and Quality Control
  5. Statistical Analysis of Clinical Study
  6. Interim Analysis of Clinical Study
  7. Interim Statistical report of Clinical Study
  8. Statistical Report
  9. Import/Export of data
  10. Using  the latest software

Clinical Study Logistics

The logistics services provided by us:
  1. Obtaining Import/Export Authorization
  2. Preparing documents for customs processing;
  3. Cargo customs processing;
  4. Shipment and Storage of all Clinical Study Materials and Drugs from the developer to the central warehouse in Russia and then transfer to clinical sites;
  5. Temperature controlled shipping;
  6. Biological Samples Transfer to the Central Laboratory;
  7. Purchase and shipment of the accessory equipment, different materials and accessories;
  8. Cargo distribution and transport;
  9. Cargo tracking during delivery;
  10. Cargo insurance and carriers liability insurance, if necessary.
  11. Biological Samples Transfer to sponsor when study completed.

Clinical monitoring of investigation

Clinical monitoring System is in accordance with the ICH GCP, Federal Law of the Russian Federation and examined in detail using standard operation procedures of the company. So, it guarantees:
  1. Protecting the rights and safety of subjects;
  2. High quality of received data;
  3. Fulfillment of researcher’s obligation to sponsor
Clinical monitoring system includes:
  1. Selection, opening and routine monitoring of clinical sites
  2. Inspection of regulatory study documents
  3. Evaluation of patient availability and patient meeting the Inclusion/Exclusion criteria
  4. Continual medical, technical and legal services for clinical sites (Site Management)
  5. Training and support of the site team
  6. Evaluation of site work under the Clinical Study Protocol and completeness of obtained data
  7. Permission request for CRF by Sites
  8. Preparing Monitoring Visit Reports
  9. Control of record accuracy
  10. Investigational product registration
  11. Site close-out visit

Selection of clinical sites

We have a large up to date database of clinical sites (Federal and Regional).

Long-lasting cooperation with medical centers and researchers, experienced with Clinical Studies in different treatment categories, let us match clinical sites for the most complex investigation.

Clinical site supplied during Clinical Study

During the Clinical Study and the Bioequivalence Study sites are required for equipment, medication and accessories. We will take care of sites and the logistical support of the sites.

Generating A Final Clinical Study Report

Generating a Final Clinical Study Report is the final product of all previous services. Our medical and scientific experts will generate the Report based on Clinical Study data in accordance with the ICH GCP, Russian Federal Law and Ministry of Health and the Federal State Institution “Scientific Center for Expertise on Medical Products for the Ministry of Health and Social Development of the Russian Federation” requirements.

Our team provides only well-coordinated work and mutually beneficial customer-oriented cooperation!

“Regapharm” company staff continuously monitor our projects, strictly following the company’s internal SOPs, so any mistakes and defects are excluded.
Our prices are transparent, and we fully comply with the clinical expertise standards and regulations due our highly-qualified professionals!

Use the form below to receive a detailed clinical trial consultation associated with the state registration of medicinal products in Russia.

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