Clinical trial is a scientific research involving human subjects that is conducted to assess the efficacy and safety of a new medicinal product or to expand the indications for use of a known medicinal product.
Clinical trial is world-wide essential step in medicinal product development, which precedes its registration and wider medical use. In clinical trials, a new medicinal product is studied to obtain data on its efficacy and safety. These data are an important part of the registration dossier, on the basis of which the authorized public health authority makes a decision on registration of a medicinal product or refusal to register it. The medicinal product which did not pass the clinical trials can not be registered and brought to the market.
When developing a new medicinal product it is impossible to do without clinical trials, because the extrapolation of the results of trial on animals and biological models to human is possible only in a general way, and sometimes is not possible at all. For example, pharmacokinetics (the way the medicinal product enters the bloodstream, is distributed in the body and excreted from it) in a human is different even from the pharmacokinetics in primates, not to mention the pharmacokinetics in laboratory animals such as rats, mice, rabbits and others. However, analysis of preclinical research is very important to assess the probability of development and nature of side effects, the calculation of starting dose for studying the properties of the medicinal product in humans.
Clinical trials can be initiated only after the encouraging results obtained during pre-clinical studies (studies on the biological models and laboratory animals), as well as approval by the Ethics Committee and the positive decision of the authorized body of executive power in the health care sector (Ministry of Health of the Russian Federation).
First, the experimental medicinal product is studied involving a small number of patients and/or healthy volunteers. As soon as the data is accumulated on its safety and efficacy, the number of patients involved in the study increases, and the medicinal product itself is compared with medicinal products already known and widely used in medical practice.
A separate kind of clinical trial is a study of bioequivalence of a generic (reproduced medicinal product) of the original medicinal product. You can read more about it on the appropriate page.
Our company has extensive experience in organizing, conducting and monitoring clinical trials. We help our clients to conduct small trials needed in the process of registration of the medicinal product, as well as large, full scale, and sometimes international multi-center trials. Organization of “the study on turnkey basis” is available, i.e. including all possible procedures from the preparation of documentation (protocol, Investigator's Brochure, Informed patient’s consent, etc.) to submission to the customer of the final report of the clinical trial, and separate stages and services.
A complete list of provided services:
1. Development of documentation for research
Extensive experience of organizing and conducting clinical trials allowed us to build up contacts with experts from all areas, so that we can provide a full range of scientific medical support of a clinical trial and ensure our customers a high-quality prepared material:
- Development of a study protocol
- Development of Investigator's Brochure
- Development of information for patients
- Development of a patient's informed consent
- Development of Standard Operating Procedures (SOPs)
- Development of the General Report of the Research
All documents are developed by experts in the field of medical science examination. Documents developed by us meet the standards of ICH GCP, standards submitted to FDA, EMEA, Health Ministry of the Russian Federation and the Russian Health Ministry Federal state budgetary institution Scientific Center for Evaluation of Medical Products. Scientific instruments can be developed for research trials conducted by our company and for independent projects.
Our company can not only develop for you the documentation associated with clinical trials, but also conduct an analysis of existing documents, such as your reports on preclinical studies, literature sources devoted to the sphere in which your product works, and provide you with a summary report for further action, for example if you need a clinical study, to what extent and with what features.
2. Selection of clinical sites for research
Due to long-term cooperation with medical institutions and researchers having experience in conducting clinical trials at all stages in different areas of medicine, RusClinic CRO can quickly select the most suitable clinical sites for even the most complex trial. We always act in the interests of our customers, so to develop a budget for your research, we will contact all suitable for your databases and choose the best option for you with an affordable price and at the same time guaranteed high quality of the research.
3. Passage of regulatory procedures
In accordance with Federal Law № 61-FZ of 12.04.2010 “On circulation of medicinal products” in order to conduct any clinical research in the Russian Federation it is necessary to pass examination of documents in the Ethics committee and obtain permission to conduct research in the Health Ministry of Russian Federation. For our clients we develop documentation that will best meet all the standards and requirements and will require a minimum of edits on the part of regulating authorities, and also we can represent the customer in the regulatory bodies in the process of obtaining permission.
4. Logistical support of the research
The main object of clinical research is, of course, a medicinal product. If this medicinal product is produced outside of Russia, it must be brought in, and this, in turn, requires to prepare a number of documents and to obtain permission. For its foreign partners RusClinic CRO offers a wide range of logistics services:
- Obtaining permission to import unregistered medicinal product samples for clinical studies;
- Preparation of documents for customs clearance;
- Customs clearance;
- Transportation and storage of all medicinal products and materials necessary for clinical trials;
- Compliance with the temperature regime of storage and transportation;
- Delivery of biological samples to a central laboratory;
- Provision with security of cargo and carrier's liability, if necessary;
- Delivery of biological samples to sponsor after the end of the study.
In the process of conducting a clinical trial and bioequivalence studies, databases often need to supply the necessary tools, products or consumables. Our experts take over communication with the database, and all logistics related to the acquisition and delivery of the necessary components to the clinical database.
5. Clinical monitoring
Clinical monitoring system in our company is built in accordance with ICH GCP, the laws of the Russian Federation, detailed standard operating procedures of the company, so it guarantees:
- Observance of patient’s rights and ensuring his safety;
- High quality data obtained;
- The obligations fulfillment of researchers to the sponsor
Clinical monitoring includes:
- Selecting, opening and routine monitoring of centers
- Verification of regulatory documents
- Assessment of a procedure for selection of patients and their compliance with inclusion and exclusion criteria
- Permanent medical, technical and legal assistance of the centers (SiteManagement)
- Training and support of the center staff
- Assessment of the center work for compliance for the study protocol, and completeness of the data collected
- Resolution of requests on Case Report Form with the centers
- Confirmation of correctness of reports
- Study Drug Accountability
- Conduct of visits of closing
- Preparation of reports on monitoring visits.
6. Ensuring the quality of research
Standard Operating Procedures developed by our company with the participation of large foreign partners cover virtually the entire field of RusClinic CRO.
In the case of long-term projects, we are ready for audit on your part to verify compliance with contractual requirements, the needs of sponsors. We want to maintain the confidence of sponsors to our opportunities to provide quality services and improve existing processes. We provide services on audit of conducted clinical trials. Our experts in quality assurance of studies may assess whether a study carried out corresponds to ICH GCP, local laws and the study protocol.
7. Processing of data obtained during the study
We understand how important is high-quality processing of the data received from the study, their structuring and standardization. Therefore, we have a responsible attitude to the preparation of studies and working materials, research monitoring (we control the quality of filling and provision of information by researchers), and subsequent work with the results of the study. Thus, our work with the data is based on the following points:
- Design of Case Report Forms (CRF) / Diary of patients
- Development of a scheme of validation of input data (for e-CRF)
- Import of laboratory results
- Coding of adverse events
- Coding of medical records
- Elimination of contradictions in the reports.
8. Statistical analysis of data
It is important not only to collect correctly the obtained results of clinical trials, but also to calculate correctly. Statistical analysis is extremely important and very time-consuming part of the report on the clinical trial, making it possible to justify mathematically all the conclusions. Our statistics use modern techniques and latest developments in software for statistical analysis. To ensure that our investigations to be indicative and to receive guaranteed accurate, statistically significant results, we work with experts in statistics from the very start of the study:
- Preparation of the study design
- Preparation of a plan of statistical analysis
- Design of tables
- Design of data display
- Statistical analysis
- An interim analysis
- An interim statistical report
- Statistical Report
9. Development of final report
Final Report is the end, final product of all the above services. Our experts are medical and scientific experts from the entire array of data obtained during the study; they will develop a report that will correspond to ICH GCP, the requirements of Russian legislation and the Federal state budgetary institution Scientific Center for Evaluation of Medical Products of Health Ministry of Russian Federation. We guarantee you'll be pleased with the result.