Granconsult

Clinical Studies

Based on modern clinical research, medicine and pharmaceuticals have achieved huge results in medical sciences and have made a major breakthrough through the successful adoption of their newest inventions.

The main goal of any clinical study is the scientific investigation of a new drug or treatment method, determining its safety and efficacy, and is carried out with the voluntary participation of people. Clinical studies facilitate the further adoption of the investigated products into clinical practice.

Clinical studies of drugs and pharmacological products

Clinical studies of drugs have particular importance in modern pharmacology. To confirm physicians’ empirical experience with a particular drug and to rule out pathological effects on future patients, it is necessary to scientifically confirm the drug’s action and safety. Pharmaceutical market participants usually independently decide on volunteer involvement in clinical testing. Granconsult fully assumes responsibility for the quality of the research performed.

Modern clinical studies of drugs are conducted in accordance with international standards and rules (Good Clinical Practice). Drug studies serve to investigate the therapeutic efficacy and tolerability of drugs in humans. They help doctors give more accurate prescriptions and patients to be better informed about possible contraindications and side effects.

Quality standards and the purpose of clinical studies

In accordance with international clinical-study principles and rules, the study defines the goal and the investigational drug, accurate supporting documentation is prepared, legal and ethical requirements for the study as a whole are considered, and requirements are set for doctors, research leaders and patients. Clinical studies establish the drug’s use rules, level of safety and therapeutic value.

Phases of clinical trials

Before a drug can be officially approved for medical use, so-called clinical phases are performed in 4 stages.

  1. The first stage is typically work with a group of healthy volunteers. This yields data on the need for further development of the drug and studies its pharmacology and physiological effect on the human body.
  2. The second stage involves more people. If the drug is recognized as safe it is tested on people with diseases or syndromes for which the active substance is intended.
  3. The third stage aims to determine the overall and relative therapeutic value of the drug’s active substance. Side effects on use are studied.
  4. The fourth stage is for refining the indications for dosing and studying the results of long-term treatment.

Our company has extensive experience in organizing, conducting and monitoring clinical studies. We help our clients to conduct both small studies required in the drug-registration process and large, full-scale and sometimes international multicenter studies. We offer either “turnkey” studies — all possible procedures from documentation preparation (Protocol, Investigator’s Brochure, Informed Consent, etc.) through delivery of the final clinical-study report — or individual stages and services. We offer:

1. Development of study documentation

Our extensive experience has allowed us to build contacts with specialists in all areas, giving us the ability to provide a full range of scientific medical support for clinical studies and to guarantee high-quality materials to our clients:

  • Development of the Study Protocol
  • Development of the Investigator’s Brochure
  • Development of Patient Information
  • Development of the Patient Informed Consent
  • Development of Standard Operating Procedures (SOPs)
  • Development of the General Study Report

All documents are developed by specialists in medical scientific expertise. The documents we develop comply with ICH GCP, the standards imposed by FDA, EMEA, the Russian Ministry of Health and the Federal State Budgetary Institution “Scientific Center for Expert Review of Medical Products.” Scientific documents can be developed for studies conducted by our company or for independent projects.

Our company can also analyze existing documents — your preclinical reports, literature related to your drug — and provide a consolidated report on next steps, e.g. whether you need a clinical study, of what scope and with what specifics.

2. Selection of clinical sites

Thanks to long-term cooperation with medical institutions and investigators experienced in all stages of clinical studies across various medical fields, our organization can quickly select the most suitable sites even for very complex studies. We always act in our clients’ interests; when preparing your study budget we contact all suitable sites and propose the optimal option — at a price acceptable to you and with guaranteed high study quality.

3. Regulatory procedures

Under Federal Law No. 61-FZ of 12 April 2010 “On the Circulation of Medicines,” any clinical study in the Russian Federation requires expert review by the Ethics Committee and authorization from the Ministry of Health. For our clients we prepare documentation that meets all standards and requirements and requires minimal edits from the regulators; we can also represent the client before the authorities during the authorization process.

4. Study logistics

The main object of a clinical study is, of course, the drug. If the drug is produced outside the Russian Federation it must be imported, which requires preparing a number of documents and obtaining authorizations. For our foreign partners we offer a wide range of logistics services:

  • Obtaining authorization for the import of samples of an unregistered drug for a clinical study;
  • Preparation of customs clearance documents;
  • Customs clearance;
  • Transportation and storage of all drugs and materials required for the clinical study;
  • Compliance with storage and transport temperature requirements;
  • Delivery of biological samples to the central laboratory;
  • Provision of cargo insurance and carrier liability if required;
  • Delivery of biological samples to the sponsor after the study.

During both clinical and bioequivalence studies, sites often need to be supplied with specific instruments, drugs or consumables. Our specialists will handle communication with the sites and all logistics for procuring and delivering the necessary components to the clinical sites.

5. Clinical monitoring

Our clinical monitoring system is built in accordance with ICH GCP, Russian laws and our detailed Standard Operating Procedures, and it guarantees:

  • Protection of the patient’s rights and safety;
  • High quality of the data obtained;
  • Fulfillment of the investigators’ obligations to the Sponsor.

Clinical monitoring includes:

  • Site selection, initiation and routine monitoring
  • Review of regulatory documents
  • Assessment of patient selection and inclusion/exclusion criteria compliance
  • Ongoing medical, technical and legal support of the sites (Site Management)
  • Training and support of site personnel
  • Assessment of site compliance with the protocol and data completeness
  • Resolution of queries on CRFs with sites
  • Verification of reporting
  • Investigational drug accountability
  • Close-out visits
  • Monitoring-visit report preparation

6. Quality assurance of studies

For long-term projects we welcome audits from your side to verify compliance with contractual requirements and sponsor needs. Our quality-assurance specialists can assess how well a study complies with ICH GCP, local laws and the Study Protocol.

7. Processing of study data

We understand the importance of high-quality processing of the data obtained, its structuring and standardization. That is why we treat study preparation, monitoring (checking the quality of information completed and provided by investigators) and subsequent work with the study results very responsibly. Our data work is built on:

  • Case Report Form (CRF) / Patient Diary design
  • Development of a data-validation scheme (for electronic CRFs)
  • Import of laboratory data
  • Coding of adverse events
  • Coding of case histories
  • Resolution of inconsistencies in the reports

8. Statistical analysis of data

Collecting the results of a clinical study correctly is not enough — they must also be analyzed correctly. Statistical analysis is an extremely important and labour-intensive part of writing the Clinical Study Report, providing the mathematical underpinning for all conclusions. Our statisticians use modern methods and the latest software for statistical analysis. To make our studies more informative and to obtain reliable, statistically significant results, we involve statistics specialists from the very beginning of the study:

  • Study design preparation
  • Statistical analysis plan preparation
  • Table design
  • Data-display design
  • Statistical analysis
  • Interim analysis
  • Interim statistical report
  • Statistical report

9. Final report development

The final report is the end product of all the services listed above. Our specialists — medical and scientific experts — will develop a Report based on all the data obtained during the study, in compliance with ICH GCP, Russian legislation and the requirements of the Russian Ministry of Health and the FSBI Scientific Center for Expert Review of Medical Products. We guarantee you will be pleased with the result.