Looking for suitable Contract Research Organization?

Looking for suitable Contract

Research Organization For your clinical or preclinical trials?

X7 Research is a reliable partner in clinical trials, registration of drugs and medical devices, pharmacovigilance since 2010. Our company is a contract research organization (CRO) offering a full range of research services of the development and registration of medicines and medical devices in Russia, the EAEU, the CIS and the EU. Clinical and preclinical trials are an important part of a drug circulation. 

send us an email to info@x7research.ru

Our contract research organization can help in:

  • research and consultation in the process of a drug development for further clinical trials
  • conducting clinical trials at different phases, including both early and late phases

  • registration, introduction of changes in the registration dossier to regulatory authorities

  • post-marketing of the drug

  • organization of a pharmacovigilance system, preparation of periodic reports and maintenance of other documentation

  • home care services

X7 Research puts a lot of effort to provide its’ clients with the best services in clinical trials 

send us an email to info@x7research.ru

Do you need more infromation?

    send us an email to info@x7research.ru

    Why clients choose our CRO

    X7 Research company is a contract research organization (CRO) that provides a full range of services from consulting, research, preparation of registration strategy, planning and conducting Phase I-III clinical trials, registration, post-registration studies (Phase IV, NIS) and pharmacovigilance. Our company is based on the principles of the highest quality. GCP standards are our core values.  On the other hand, there are many contract research organizations (CROs) involved in preclinical research within the framework of the law. An example is the well-known company Bioneeds preclinical CRO.

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    X7 Research’s company primary responsibility is to help our clients in bringing medicines & devices to the market efficiently and safely.

    X7 Research company is ready to conduct clinical trials and provide research support activities

    Contact us

    Our Email: info@x7research.ru

    WHAT IS Contract Research Organization?

     CRO provides research services to pharmaceutical, biotech and medical devices companies. Services may vary: registration of drugs, pharmacovigilance, conducting clinical trials and preclinical trials in different therapeutic areas. 
    It is important that CROs are different, and their specialization also varies depending on the company and its scale. There are a lot of preclinical CRO at the pharmaceutical market. 
    To conduct a clinical and preclinical trials, a sponsor uses the services of a CRO to fulfill a contract for a specific project or contract for several projects at the same time. 
    Thus, a sponsor does not need to hire full-time staff and it saves the research budget.

    What Does A CROs Do?

    Contract Research Organizations (CROs) are companies that conduct clinical and preclinical trials and provide research support services in various therapeutic areas, for example, cardiology, oncology, neurology, hematology, dermatology, ophthalmology, and others. Preclinical CRO companies are also common in various therapeutic areas dominated by oncology and ophthalmology.

    OUR SERVICES

    Group 11

    Registration strategy & consulting

    – Registration strategy & consulting
    – Data search and analysis
    – Registration strategy development of drugs and medical devices
    – Study feasibility
    – Vendor selection depending on the project
    – Clinical trials budgeting

    X7 Research has extensive experience in finding and analyzing information about specific medicines to prepare a drug registration strategy in Russia, the EAEU, the CIS, the EU. X7 Research is a reliable partner for challenging regulatory environments and a tough economy.      

    Post-authorization clinical studies

    – Phase IV studies

    – Non-interventional studies

    – Post-authorization safety study

    X7 Research offers a wide range of services in the post-marketing phase of the drug lifecycle. Our company is ready to conduct both large-scale studies to obtain big amounts of a real-world data (RWD) and small-scale exploratory studies. The X7 Research team is ready for any challenge and the most ambitious projects.

    Group 15

    Pharmaco-vigilance

    – Building a system of pharmacovigilance

    – Safety in clinical trials

    – Pharmacovigilance audit

    – Pharmacovigilance contact person

    X7 Research company offers a wide range of services in all phases of building a pharmacovigilance system. With a great experience X7 Research offers a full range of FV services in the EAEU that enable you to meet pharmacovigilance requirements of the market. Our PV specialists carry out high-quality documentation of PSUR, DSUR and others.

    Clinical trials

    – Development of medical documentation and biostatistics
    – Monitoring
    – Data management
    – Patient home visit
    – Bioequivalence study
    – Therapeutic equivalence studies

    The X7 Research team always tries to find individual solutions for each partner and each clinical trial in compliance with the therapeutic area of a research. X7 Research has been conducting monitoring visits since 2010, both on-site and remotely in Russia, EAEU, CIS, EU. The strength of our specialists’ work is the implementation of thorough data control, as well as constant interaction with the client.

    Registration

    –  Audit of the registration dossier

    – Bringing the registration dossier in compliance with the requirements

    – Conversion of registration dossier into XML format

    – Custom testing of the package insert

    X7 Research provides services for a state registration, modification of a registration dossier, confirmation of a state registration of domestic, foreign, original, and reproduced medicines on the territory of the Russian Federation and the Eurasian Economic Union. The contract research company provides qualified assistance in the registration of medicines. Specialists of X7 Research can advise a client at all stages of the registration of a medicinal product. Employees of X7 Research can conduct a qualitative analysis of a dossier for compliance with all regulatory requirements. After a review, the client receives recommendations for each section of the registration dossier, which further helps to minimize the risks of submitting the registration dossier to the regulatory body.

    START A PROJECT WITH X7 RESEARCH

    Our email: info@x7research.ru

    Our goal is to conduct research activities, explore the potential of young professionals and provide quality services to partners and clients of clinical trials, include consultations, registrations, monitoring and other services.

    Contract Research Organization Roles and Responsibilities in clinical and preclinical trials

    The CRO in clinical and preclinical trials is responsible for the planning, setup, routine execution, and management. Also, an important part of a work of the organization is the processing and control of technical aspects of a data collection and medical testing, this function in X7 Research is performed by the data management department. 

    Clinical and preclinical compliance are critical, as is adherence to Good Clinical Practice (GCP) and Good Laboratories Practice (GLP) standards. In summary, CROs play a role of a bridge between the sponsor, regulators, ethics committee, vendors, hospitals, researchers, and other stakeholders. There are some feathers to sponsor to work with a CRO in clinical and preclinical trials: saving the budget, project management to the CT, minimum interactions with the regulator, no need to hire an additional staff. When preparing a commercial proposal, CROs use preclinical trials directors to formulate the correct price, considering the risks of the trials.

    OUR PURPOSE

    X7 Research’s company primary responsibility is to help our clients in bringing medicines & devices to the market efficiently and safely. We are reliable partner in clinical trials since 2010.

    X7 Research’s primary responsibility as a contract research company (CRO) is to help our clients to bring medicines and devices to the market efficiently and safely, at short notice and with significant reductions in research budgets. We are a reliable partner in clinical trials since 2010. X7 Research can help in a strategy development of interventional studies, a preparation of literature reviews, a preparation of post-marketing and non-interventional study concepts. Our medical writers have extensive experience in developing clinical trial documents. We will help in the selection of the study endpoints, justification of the required sample size, and the options of correct statistical methods for the analysis of the efficacy and safety parameters of the investigational product.

    Better

    We help organizations trade with integrity and trust

    Safer

    We ensure safety in everyday life, at home and at work

    Interconnected

    We help new technology to reach consumers quickly

    Do you ready to choose X7 Research company as a CRO? Email us to info@x7research.ru

      BENEFITS OF OUTSOURCING TO A CRO in clinical and preclinical trials

       Outsourcing to a Contract Research Organization can bring multiple benefits to your clinical or preclinical trials.

      Time Savings

      Working with a CRO to conduct a trial often significantly reduces time it takes compared to completing the trial in-house.

      An important addition is the possibility of remote visits, which is especially important in the context of COVID-19.  Laboratories capabilities allow your company to conduct research faster.

      Trials Cost Savings

       By hiring a CRO, you can save a lot on your clinical research budget.

      By itself, a faster litigation offers healthcare providers cost savings, such as hiring staff for a project or permanent job.


      Advanced Technological Needs

      Working with CRO gives hiring companies access to the most advanced technologies and systems for data management, product development, research analysis and other clinical research services. 

      IT capabilities, Internet applications and competent specialists are an important advantage of our company. This is what allows us to help accelerate clinical trials while maintaining comprehensive quality control within an evolving pharmaceutical industry.

      Evolving and Complex Regulatory Requirements

      Regulatory authorities require complex and accurate data to be approved and allowed to conduct clinical trials and preclinical trials. CROs work within clinical compliance on a daily basis, which gives them intricate knowledge of regulatory requirements and audits such as Good Clinical Practice (GCP) audits or Good Laboratory Practice (GLP) audits.

      CROs work optimizes audit results through careful review of any previous issues, close inspection of infrastructure, and adherence to current protocols.

      Let’s check some X7 Research figures

      12

      years of experience

      100

      projects involved

      more than

      90%

       of international clients

      55

      open sites

      Our company works with you from the first stages of clinical trial to the final registration the drug

      Our Email: info@x7research.ru

      This is what our clients say about us:

      What is a contract research organization in Clinical and Precilical Trials?

      What is a contract research organization in Clinical Trials?

      The CRO is the organization that plans, develops, and coordinates the clinical and preclinical trial protocol. A contract research organization (CRO) helps to conduct clinical or preclinical trials for a sponsor for one or more drugs or medical devices. The sponsor can be attracted the experience of the CRO. 

      Through the CRO’s repeated trial after trial, which can anticipate possible delays and gaps in the trial and avoid them in advance.

      How X7 RESEARCH company works

      1

      Conducting a gap analysis

      2

      Literature review

      3

      Document review

      4

      Preparing a drug registration strategy

      Our contract research organization provides a systematic approach to solving clinical trials

      Do you need more infromation?

        send us an email to research@x7cpr.com

        Our contract research organization provides a systematic approach to solving clinical trials

        send us an email to info@x7research.ru

        Working with a CRO
        Group 17 (1)

        Selecting a CRO

        There is a wide variety of CROs. Some of them are large state-owned companies with a global reach and a wide range of comprehensive services, while other CROs are small private companies specializing in a particular therapeutic area.

        Comparing one CRO to another can be very difficult, as CRO budgets and services often vary significantly from one preclinical CRO or other clinical or preclinical CRO to another. So, preclinical CRO offers a certain range of services and specialization, while others offer a full range of services for customers. When choosing a preclinical CRO or clinical CRO, look at the company’s previous experience, including types of projects they’ve completed, the clients they’ve worked with, any niche services.

        Sponsor’s Responsibility

        Organizations often outsource any or all of their clinical or preclinical trials and research responsibilities to a CRO, but the responsibility remains with the original company that hired the CRO. The quality and integrity of clinical or preclinical trials data remains with the sponsoring organization. 

        That is why the CRO should provide quality work in accordance with government requirements of GCP and other.

        Get It In Writing

        When hiring a CRO, always ensure each delegated task is outlined in writing and signed by both parties. All agreements should be thoroughly documented by all of the involved parties to avoid any costly misunderstandings or complications. 

        It should be very clear which organization is responsible for each aspect of the medical research, development, or other clinical and preclinical services. It is important to clarify all the nuances and details before the study to avoid misunderstandings.

        What Is CRA and Manufacturing Services?

        Contract Research and Manufacturing Services (CRAMS) is a broader clinical outsourcing term that includes CROs as well as CMOs, Contract Manufacturing Organizations.
        Contract Manufacturing Organizations (CMOs) are like CROs, in that they are also hired by another pharmaceutical company on a contract basis. The purview of a CMO is in the development of a drug through to its manufacturing.

        They all make up a rapidly expanding segment of the biotechnological and pharmaceutical industry. Outsourcing specialized clinical and preclinical research and manufacturing work continues to develop as organizations aim to meet the needs of an evolving industry.

        START A PROJECT WITH X7 RESEARCH

        send us an email to info@x7research.ru

        BLOG

        It’s important to respond quickly to an ever-changing environment in a COVID-19 pandemic.  Today we will tell you how to function with clinical trials in accordance to new conditions. 

        Market share of original medicines in Russia is incredibly small because of great costs of drug development, pre-clinical and clinical trials of an original drug.

        Russian pharmaceutical market size in 2016 reached 1,344 billion rubles, which is 7% higher than a year earlier, and in 2017 reached 1,629 billion rubles, which is 8% higher than in 2016.

        FAQ

        A contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries by offering research services on a contract basis. A contract research organization may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, contract research, clinical trials management, and pharmacovigilance

        CRO is the abbreviated form for Contract Research Organization

        X7 Research company is a Contract Research Organization offering a full range of services at all stages of drug development and registration in Russia, EAEU, CIS, and EU

        X7 Clinical Research is a modern center specializing in conducting clinical studies in bioequivalence and Phase I, II, III studies and post marketing drug research. Clinical center is equipped with modern equipment and has a well-developed infrastructure, including all the necessary premises for conducting clinical trial. In addition, company has an extensive referral network of doctors to invite patients and healthy volunteers.

        X7 Research had frequency audits from Big pharma. We are qualified vendor for more than 100 pharma companies.

        X7 Research company offers services «in house» in the area of clinical research, bringing outsourcing solutions to the Pharmaceutical, Drug, Biological and Device Industry. Design of study documents, selection and management of investigational sites, subject recruitment, project management and monitoring.

        CONTACT US

        Contact us:

          Our Email:
          info@x7research.ru

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