HELSI

Clinical tria

Clinical research - research involving human subjects that is conducted to assess the efficacy and safety of new medicinesor an expansion of indications for already known medicines. Around the world clinical studies are an essential step in the development of medicinesthat precedes the registration and broad medical use. In clinical studies new medicinesarebeing studied to obtain data on its efficacy and safety. These data are an important part of the registration dossier, on the basis of which an authorized public health authority shall take a decision on registration of the drug or the refusal to register. If drug did not pass the clinical trials it may not be registered and placed on the market.

A full list of services:

1. Selection of clinical databases for research

Thanks to long-term cooperation with medical institutions and researchers with experience in conducting all phases of clinical research in different fields of medicine, HELSI can quickly select the most suitable clinical sites for even the most complex study. We always act in the best interests of our customers, so developing a budget for your research, we will get back with all the appropriate bases for you and choose the best option for you at a reasonable price and with guaranteed high-quality research.

2. Passage of regulatory procedures

To conduct any clinical trial in Georgia it is necessary to pass examination of documents in the Ethics Committee and to obtain permission to conduct research in the Ministry of Health of Georgia. For our customers we develop documentation that will best meet all standards and requirements and will need a minimum of edits by the regulatory authorities, as well as we can represent the customer in regulators in the course of obtaining permission.

3. Logistical support for research

The main object of a clinical trial is, of course, the drug. If this drug is produced outside of Georgia, it is necessary to import, and this, in turn, is necessary to prepare a number of documents and obtain permission. For our foreign partners HELSI offers a wide range of logistics services: Obtaining permission to import samples of the unregistered medicines for clinical research; Preparation of documents for customs clearance, customs clearance, transportation and storage of all the necessary preparations for clinical research and materials. Observe the temperature of storage and transportation; Delivery of biological samples to a central laboratory; Providing cargo insurance and liability of the carrier 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 equipment, drugs, or supplies. Our experts will assume communication with bases and all logistics connected with acquisition and delivery of necessary components on clinical bases.

4. Clinical monitoring

Clinical monitoring system in our company is built in accordance with ICH GCP, the laws of Georgia, detailed standard operating procedures of the company, so it guarantees: Respect the rights of patients and ensure their safety, High quality of the data, Implementation of obligations of researchers before the Sponsor

Clinical monitoring includes:

Selection, opening and routine monitoring of centers
Verification of regulatory documents
The evaluation procedure of selection of patients and their compliance with the inclusion and exclusion criteria
Constant medical, technical and legal support centers (Site Management)
Training and support center
The evaluation of the center for compliance to the study protocol and the completeness of the data collected
Resolution requests the IGC with centers
Validation reports
Consideration of the study drug
Carrying out of closingvisits
Preparation of reports on monitoring visits

5. Ensuring the quality of research

Standard Operating Procedures developed by our company with the participation of major foreign partners, cover almost the entire field of HELSI .In case of long-term projects, we are ready to audit of you for check of compliance to contractual requirements, needs of sponsors. We want to maintain the trust of sponsors for our ability to deliver quality services and improve existing processes.
We are providing services in audit of conducted clinical studies. Our specialists to ensure the quality of research can assess whether conducted research meets ICH GCP, local laws and protocols of the study.

Registration of medicinal products

The process of registration of medicinal products consists of several steps:

1. The procedures for obtaining authorization to conduct a clinical trial (if necessary).
2. Procedures for examination of the quality, effectiveness and safety of the medicinal product.

Registration steps:

• study of the submitted documentation;
• conducting consultations with experts of the executive bodies;
• the signing of the contract between the customer and the service provider;
• pre-registration preparation of documentation;
• pharmacological examination;
• the conduct of clinical trials (individually);
• issuance of registration certificate.



HELSI

• preparation of the registration dossier;
• development of regulatory documents;
• conduct of clinical trials;
• accompanying of the registration process;
• obtaining of a registration certificate;
• translation of medical text;
• making amendments to the documentation on the medicinal products;
• preparing the instructions for medical use in the local language.



We draw your attention to what categories of products subject to compulsory state registration:

• medicinal products of own development;
• licensed products;
• not previously encountered a mixture of already registered pharmaceuticals;
• previously registered drugs which have been reproduced in other dosage, other medicinal form.



We draw your attention to what types of drugs are not subject to compulsory state registration:

• medicines that have been manufactures by persons having the necessary license for pharmaceutical activity, taking into account the requirements of a variety of medical, veterinary organizations, in accordance with prescription;
• medicines purchased by individuals outside Georgia and imported into the country for personal use;
• radioactive medicines for the treatment of cancer, made in medical institutions;
• medicinal raw materials of a herbal origin.



Also be aware that is not permitted to register the medicinal products:

• produced by one manufacturer under different names but the same formulation;
• having different formulation and the same brand name.



The procedure for registration of medicines is:

• ... working days - for original medicinal products;
• ... working days - for generic medicinal products.

Registration of drug substances

Registration of drug substances is carried out in accordance with the Georgian legislation.

Registration of medical devices

The concept of "device for medical use" includes instruments, equipment, devices, kits, complexes, systems with software, hardware, tools, bandaging and stitching tools, dental materials, reagent kits, reference materials and standard samples, including standard sets of red blood cells, to determine human blood groups and rhesus - accessories, as well as calibrators, consumables and other articles intended for:

• prevention, diagnosis (in vitro), treatment of diseases, rehabilitation, medical procedures, medical research, replacement parts and modifications of tissue organs, repair or compensate for lost or damaged physiological functions, control over conception;
• effects on the human body, so that their functions cannot be implemented by chemical, pharmacological, immunological or metabolic interaction with the human body,  though which way of action can be supported by such means.

Company HELSI provides consulting services for import and export of medical products. We are always at your disposal for any additional questions and information you need.

Entering a new market

Access to the new, untapped trade market for a company, it always envisages high risk and complicated task. A decision to enter a new market shall not made spontaneously and has to be based on the data that enable predict the further life cycle of the product with high level of certainty.

We perform not only the processing and analysis of data and pure compilation of reports. We are developing a list of recommendations, strategies, and ways to develop your medicinal product on the Georgian market, we take into account existing market trends, we study the competitive environment (the presence of similar or analogical products, the demand for this medicine or drug substance, the reputation of competitors and their marketing strategies) and the situation in the field of registration of medicines and pharmaceutical substances, knowledge and needs of physicians. Guided by the findings, we can help you predict future demand, potential sales and also we offer development of marketing strategy. Experience and knowledge of our employees and the involved experts allow us to guarantee high quality of obtained data and allow you to enter the market in an optimal way.

We can render consultations on an exit a preparation on the Markets of such countries as Armenia, Kazakhstan and Azerbaijan.

Consultation on the formation of the dossier

If your company needs advice and assistance in the formation of a registration dossier for pharmaceuticals and pharmaceutical substances, we will write you a basic documents (НД и ИМП), provide a list of documents that need to be compiled in the files, check them, translate (if necessary) - draw layouts and provide you with the finished folder to which you're able to go to the Ministry of Health of Georgia. If you have some questions, we will be happy to answer them.

Promotion, implementation and planning

  One of the main prerequisite to increase the profitability of the product is properly conducted market research and implementation based on these marketing strategies.
  Another factor that ensures profitability increase of the product is its novelty but in the case of the pharmaceutical market, even innovative product needs those physicians and patients received information on it, its advantages and shortcomings.

Customers of HELSI receive a wide range of opportunities: to establish contacts with potential partners and customers - patients, doctors, and opinion leaders. We help our clients to organize conferences with leading experts.

Another important aspect of our work is to work with professionals - doctors, who need to obtain detailed information about the new drug product learn how, when, and under what conditions it is or it is no recommended to use this drug product, what are the advantages over the already known pharmaceuticals, receive data on drug interactions. Careful study of strategy with guarantee will bear fruit - successful promotion and substantial sales.

Translation, Printing, Notary

In the process of registration of drug products or organization of clinical trials it is required to work with the medical and pharmaceutical documents in different languages, especially when the manufacturer of the product or one of its active ingredients is a foreign company.
Pharmaceutical and medical documents contain a lot of specific special terms, so we work with professional translators. As a rule, the texts are checked by experts in the field of medicine, chemistry and pharmaceutics.
Observing the rules of GCP, the main documents shall be submitted in English. When conducting clinical trials in Georgia, we must remember that many investigators still do not command English, so it is necessary to provide bilingual documents.
Our company is responsible for the quality of the documents drawn up by it - one of the components of the translation and submission of documentation is in the correct format and binding.
All documentation at the request of regulators or the customer may be notarized in an expeditious manner.

Storage, sale, logistics, distribution

The main goal of any pharmaceutical company that approaches us for assistance in registration of the medicinal product (or substance) in clinical or pre-clinical studies, market analysis or market research is to sell its products to the end user. For this reason the range of our services also includes distribution of medicines, as well. 
Depending on the needs and capabilities of partner we can develop the necessary set of services and offer the most favorable conditions. For example, for foreign companies that do not have a representative office in Georgia, we can offer a full range of services:

• The importation of drug products.
• Custom clearance
• Transportation (logistics services)
• Storage in specialized stores in compliance with the temperature regimes (including technologically sophisticated)
• Further delivery to pharmacies and healthcare/preventive facilities.

We work in partnership with trusted and reputable companies throughout Georgia and the region as a whole (GeoStorage), allowing you to effectively organize distribution of medicinal products throughout Georgia including the most remote regions.

Postmarketing

HELSI company provides quality services for all phases of clinical trials (I-IV) medicinal products at profitable terms. We attach particular importance to the rapid selection of patients, careful selection of the trial site, process control and test results. The fourth phase of the research is conducted after the study drug product was registered by certain indicators, and it becomes available in retail stores. The aim of Phase IV is to obtain additional information about the drug's safety, risks and benefits of its application, the identification of previously unknown side effects, as well as optimizing the usage of products on favorable terms.

The IV phase of researches is required for the following:

• improvement of the scheme for dispensing drug product
• studying interaction with other drug products
• comparative analysis with other standard drug products
• application of the drug product in other age groups or for patients of other categories
• impact of the long-term effects of the drug product on survival (decrease or increase in mortality)
• the results of long-term use for patients of different groups

Even after the trial of the drug products with participation of thousands of volunteers the full effect of its application will be studied in the post-marketing studies. In this phase, it is possible to detect unusual side effects, and long-term side effects, which requires long-term studies. Phase IV of clinical trials is associated with drug products that are already licensed, and therefore available for physicians and patients. Georgian Ministry of Health and the Ethics Committee are monitoring adverse drug reactions in a variety of ways, including active, prospective monitoring.
Creating well-functioning structure for timely detection of adverse drug reactions has certain advantages for clinical phase IV studies.

Transportation of patients, courier services

The company HELSI renders express delivery services and support in the organization of transportation of patients to and from clinical sites.