non clinical studies

CRO in Russia - Clinical Excellence Group (CEG)

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clineg.com/non-clinical-studies

Non-Clinical Studies

Your company will get successfully conducted Non-Clinical Studies of drugs, medical devices or food supplements.
In-vitro and in animals.
From idea to NCS Final Report.
In English, Russian and national languages.
On time and to high quality standards.
You will enjoy the quality and reliability of our services and our commitment to result.

What about Non-Clinical Studies?

Non-Clinical Studies (NCSs) are an essential component of the early stages of drug development and registration.

Their goals, scope and design are determined by characteristics of a drug and by national regulatory requirements.

For example, in case of oral immediate-release generic drugs it is sufficient to carry out comparative studies of acute and sub-acute toxicity with an assessment of local irritative effect in small laboratory animals. However, there are some exceptions to this rule.

The programme of NCSs of biosimilar and originator drugs is even more complicated and is mainly determined by the novelty of their chemical structure, pharmacokinetics, supposed therapeutic indications and side effects.

However, the developing a programme and optimal design of studies is only the first, although important, stage.

The next stage is to conduct the research studies within SET DEADLINES and in HIGH QUALITY. And then, the data need to be processed and findings need to be presented in Final Reports. They are submitted as part of the drug registration dossier. Moreover...

Non-Clinical Studies involve drug logistics, paperwork, data management and tailoring the Report to the requirements of appropriate national regulatory authorities.

Have a look at our offer and learn how we can help to accomplish these tasks and prevent any problems.

We guarantee: Your Company will receive timely Non-Clinical Study Reports needed for drug registration.
All studies are conducted only in trusted laboratories in Russia.
We take responsibility for high quality of research, documentation, logistics, statistical processing and reporting.
Please, also do not hesitate to contact us also, if you are interested in Non-Clinical Studies of medical devices and food supplements.
Just let us know your goals and we will help you get there.

How can we help your company?

We develop a Project Plan, Design, Timeline and Budget of Non-Clinical Studies (NCSs) depends on Your Company's goals, deadlines, resources.

We provide consultation on manufacturing and quality of laboratory batches of drugs / other healthcare products for NCSs.

We organize import of non-commercial samples of drugs / food supplements / medical devices for NCSs.

We provide consultation on Russian / EAEU / EU regulations to manufacturing, quality, registration, Clinical Trials, Non-clinical and Observational Studies, marketing and promotion of drugs.

We organize translation of all documents into / from Russian.

We find Investigation Sites (ISs, Research Centers, Laboratories) and obtain necessary documentation from them and their Independent (Local) Ethics Committees (IECs).

We carry out all stages and activities of NCS.

We conduct routine project control and audits of laboratories to ensure high quality and proper duration of NCSs.

We perform Statistical Analysis.

We prepare NCS Final Reports in compliance with requirements of Russia, the EAEU and international norms (if needed - FDA, EMEA etc.).

We deliver complete set of NCS documentation to a Sponsor.

We write articles for publication in scientific journals or media in Russian and English based on NCSs findings (if needed).

What you get when you work with us?

You get Non-Clinical Studies of any type.
Depending on characteristics of the drug / healthcare product, different types of studies may be required for its registration, such as studies of:
✔ Acute toxicity;
✔ Sub-acute toxicity with an assessment of local irritative effect;
✔ Chronic toxicity with an assessment of local irritative effect;
✔ Allergenicity;
✔ Immunogenicity;
✔ Mutagenicity;
✔ Carcinogenicity;
✔ Pharmacokinetics;
✔ Specific activity.
Your Company will be provided with results of any necessary NCSs in laboratory animals and in-vitro!
You use our broad expertise and individual approach to your tasks.
We will work together to define your goals. We develop an optimal plan and design of your NCSs.
Executive staff and key specialists of CEG have profound knowledge and vast experience in NCSs, Clinical Trials, Registration of Drugs, Food Supplements and Medical Devices.
You can see for yourselves, when you receive answers to your questions or, for a start, take a look here.
You will know all details of your project before its start and before we sign a contract. More predictability - no worries!
You will be provided with a Budget and Timeline of your project in just 5-7 days after contacting us and discussing the details.
We know, that it is crucial to understand, what investments are needed and at what stages, how long an NCS will take, and when exactly test drug and reference medicines will be needed.
And yes, it is free of charge.
We are cooperating with 15 companies and have completed 40+ NCSs in Russia.
Also we have 23 registered Drugs, 46 registered Food Supplements and 19 сompleted Clinical Trials in our portfolio.
CEG executive staff and key specialists have 120+ Phases I to IV, BE, TE Clinical Trials of generic and original medicines in Russia, Ukraine, Belarus and Kazakhstan, as well as participated in 100+ NCSs.
Unique expertise in biostatistics and medical writing.
Our team includes 6 unique medical writers and biostatisticians - there are only few such professionals in Russia and bordering countries.
And yes, we could develop dossiers and other files in English.
Right proportion of price and quality.
The cost of NCSs depends on multiple factors. Anyway, our prices 1.3-2.5 times lower than those of large Contract Research Organizations in Russia.
We need just 5-7 days to communicate you the precise cost for NCSs.
The affordable costs of our services combined with their high quality are a strong argument to work with us.
CEG has standardized business processes, so that you can be confident in quality and timeliness of accomplishing your goals.
Our work is guided by standards established on the market of drug registration and studies.
This goes for development and implementation of 38 Standard Operating Procedures (SOPs) and Policies, 100+ Standard Forms, Logs and Tables that regulate organization, monitoring and audit of
Clinical Trials, selection of Investigation Sites, logistics, drug circulation, pharmacovigilance and study participants' safety, conduct of NCSs, adverse event handling and many other activities.
This is an additional guarantee of your projects' success.
Our team is constantly improving so your project has all chances of success. And we really mean it.
Six of our specialists have more than 7 years of work experience in pharmaceutical companies and international Contract Research Organizations, four specialists have more than 12 years of experience.
In 2012-2016, CEG successfully passed 5 audits by international Sponsors.
Every year our company's staff takes an assessment of knowledge of Standard Operating Procedures and the legislation of Russia and the Eurasian Economic Union.
We carefully listen to our clients and usually respond to the query in 24 hours.
So you can always be sure that the solution of current issues is not being delayed.

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