Clinical studies of pharmaceutical products

1. Clinical trial protocol
2. Information for patient
3. Informed consent
4. Investigator’s brochure
5. Standard operating procedures
6. Summary of drug efficacy and safety
7. Final clinical trial report

All documents for clinical trial are developed by experts in the field of scientific medical expertise. All documents comply with ICH GCP, standards set out by FDA, EMEA, Ministry of Health and Social Development of the Russian Federation and FSBI Scientific Center of Expertise of Medical Products of MoHSD. Research documents can be designed for clinical trials conducted by our company, as well as for independent projects.

Here we list the main tasks completed by “RegMed prof” company in the process of organization and conduct of clinical trials. It should be noted that it is better to start the “Project preparation” stage after the development of the trial protocol and, correspondingly,after determination of its design, number of patients, tests and clinical sites. Otherwise only rough evaluation of budget can be made.

Preparation of the project. Planning of project resources:

1. Technical and economic evaluation of a clinical trial
2. Budget evaluation
3. Selection of clinical sites
4. Development of a system for monitoring
5. Preliminary training of the Project Team
6. Conclusion of contracts between trial sites and investigators, and the third party
7. Training of investigators to the clinical trial
8. Obtaining all approval documents
9. Coordination of supplies for investigators, customs clearance and shipping of materials

Project management

1. Monitoring of compliance with the interests of the sponsor
2. Effective management of the project budget
3. Monitoring of clinical trial
4. Continued interaction with the sponsor
5. Regular reports on the course of stages of clinical trial
6. Negotiating on behalf of the sponsor and management of the project

Closing project

1. Agreement on data between the project team and the data processing group
2. Coordination of disposal of biological samples or transfer them to the sponsor
3. Summarizing of data obtained during the clinical trial
4. Archiving of clinical trial materials

1. Design of CRF / Patient Diary
2. Programming of validation of entered data
3. Import of laboratory data
4. Coding of adverse events
5. Medical coding
6. Coding of case histories
7. Data import / export
8. Eliminating inconsistencies in reports

1. Preparation of clinical trial design
2. Preparation of statistical analysis plan
3. Design of tables
4. Programming of data representation and quality control
5. Statistical analysis of a clinical trial
6. Interim analysis of a clinical trial
7. Interim statistical report of a clinical trial
8. Statistical report
9. Data import / export
10. The use of the latest versions of developed software

We offer the following logistics services:

1. Obtaining necessary licenses for import / export;
2. Preparation of documents for customs clearance;
3. Customs clearance;
4. Transport and storage of all clinical trial materials and medicines from the developer to the central warehouse in Russia and then shipping to clinical sites;
5. Maintaining the required temperature conditions in the delivery process;
6. Shipment of biological samples to a central laboratory;
7. Purchase and delivery to clinical sites of additional equipment, related supplies and accessories;
8. Distribution and transportation of goods;
9. Monitoring the shipment status during delivery;
10. Cargo insurance and ensuring carrier’s liability, if necessary;
11. Delivery of biological samples to the sponsor after completion of the trial.

The system of clinical monitoring is based on ICH GCP, Russian laws and thoroughly developed company’s standard operating procedures, therefore it guarantees:

1. Observance of patients’ rights and ensuring their safety;
2. High quality of collected data;
3. Fulfillment of investigators’ commitments before the sponsor

Clinical monitoring includes:

1. Selecting, opening and routine monitoring of sites participating in clinical trials
2. Checking of documents governing a clinical trial
3. Assessment of the availability of patients and their compliance with inclusion and exclusion criteria
4. Uninterrupted medical, technical and legal support for sites (Site Management)
5. Training and support of sites’ staff
6. Evaluation of compliance of sites with the study protocol and of completeness of the data collected
7. Handling requests regarding CRF with sites
8. Preparation of monitoring visit reports
9. Checking the correctness of reporting
10. Study drug accounting
11. Conducting close-out visits

We possess a large and constantly updated database of federal and regional clinical sites. Long-term cooperation with medical institutions and investigators with experience in conducting clinical trials in different areas of medicine allows us to quickly find the most suitable clinical sites for even the most complex research.

In the process of both clinical trials and bioequivalence studies, sites often need tools, drugs or supplies. Our experts will undertake the communication with sites and all logistics related to the purchase and delivery of necessary components to the clinical sites.

Preparation of the final clinical trial report is the final product of all previous services. Our staff, comprised of medical and scientific experts, will develop a clinical trial report based on data obtained during a clinical trial that will comply with ICH GCP, requirements of the Russian legislation, as well as the Russian Ministry of Health and Social Development and FSBI Scientific Center of Expertise of Medical Products of MoHSD.

We guarantee the coordinated work of our team, fair pricing and full compliance with all rules and regulations for conducting clinical trials, because we employ highly skilled professionals in all relative areas. The entire project is conducted and supervised by the manager of the RegMed prof, whose actions are regulated by internal SOPs of the company that eliminates errors and defects of management.

These trials are intended for the evaluation of pharmacokinetic and pharmacodynamic parameters, and for preliminary assessment of drug safety. Typically from 20 to 100 healthy volunteers are included in such trials.

Because of ethical considerations, there is an exception to the rule: healthy volunteers cannot be involved, for example, when cancer or psychiatric diseases or AIDS are to be treated. These trials are conducted on patients suffering from corresponding diseases; patients are selected in accordance with the requirements set out in the trial protocol. All Phase I trials are conducted in specialized medical centers. Such trials can be open or closed, randomized and blind.

In the trial such factors are considered as absorption, distribution, metabolism and excretion.

As a rule, volunteers are paid for their participation.

These trials are aimed at assessing earlier studies conducted at Phase I with the purpose of more detailed study. In this phase, it is important to determine doses and dosage regimen for the drug. Another objective of the trial is to monitor adverse effects in the early stages of the study, so that to stop them in time, if necessary. Such trials involve 50 to 300 subjects.

Phase II is divided into:

• IIa – comparison with placebo or comparator
• IIb – comparison with standard of care

These are usually randomized and controlled trials in order to evaluate the safety and efficacy of the drug in particular indication. Phase II trials are usually conducted on a small homogeneous (uniform) population of patients selected according to strict criteria.

In such trials a control group is always used, which should not differ from the group receiving study medication as compared by the number of patients and composition. They must be the same in terms of gender, age and, if possible, previous treatment. This will enable proper comparison. These trials compare the efficacy and tolerability of a new drug in comparison with a «golden standard» (other known active drug) or placebo in the treatment of considered disease.

Sometimes the combination is allowed of Phase I and Phase II to determine the efficacy and safety.

These trials focus on confirming safety and efficacy of the drug for a particular indication in a given population, which were estimated earlier during Phase II. Phase III trials can also focus on the dose-effect relationship or use of the drug in a wider population or in patients with different severity of the disease, or in combination with other drugs. Such a trial is conducted on a wider population (from hundreds to several thousand people); as a rule, it is a randomized, controlled, blind or double-blind, multicenter (sometimes international multicenter) trial.

After this phase, a report is usually prepared, which reflects the results of clinical trials of the drug. This report is a part of the registration dossier, which is filed to public health authorities for the purpose of registration of the new drug.

In developed markets, the recommendation for wide clinical application is considered justified if the new drug:

• is more effective than known drugs having a similar effect,
• has a better tolerability in comparison with already known drugs,
• is effective in cases where the treatment with known drugs is unsuccessful,
• more economical,
• is easy to use,
• its dosage form is more convenient,
• provides a synergistic effect in combination therapy, without increasing toxicity.

This phase is implemented after the registration of the new drug with approved indications. Studies at this phase can justify expansion of the drug’s indications, collect additional data on the drug application or optimize application. The following can also be estimated: treatment duration, interactions with other drugs, treatment regimens and use of the drug in various age groups of patients.

This phase allows monitoring a lot of parameters of the drug’s life cycle.

These studies can help identify very rare adverse effects that may give reason to correct indications or, under certain circumstances, withdrawal from the market until obtaining results of a more detailed study.