Looking for suitable Contract Research Organization?

Looking for suitable Contract

Research Organization (CRO)?

X7 Research is a contract research organization (CRO) offering a full range of services at all stages of drug development and registration in Russia, the EAEU pharmaceutical market. Since 2010, X7 Research has been offering a reliable partnership for both small local companies and Big Pharma.

send us an email to research@x7cpr.com

Our contract research organization (CRO) can help in:

  • consultations in the process of clinical trials I-IV phases
  • conducting clinical trials of medical devices and medicines within the EAEU legislation
  • registration of medicines and medical devices with the EAEU regulators
  • we offer a wide range of services at the post-marketing stage of the drug life cycle
  • a qualified organization of a pharmacovigilance system for your drug
  • nursing care service for patients in Russia

X7 Research conducts research activities, expanding the development prospects of both the company’s employees and the pharmaceutical industry. Our CRO’s priority is to provide quality services and conduct safe clinical trials as a bridge between regulators, sponsors, researchers, clinical sites, and others.

send us an email to info@x7research.ru

Do you need more infromation about our CRO?

    send us an email to info@x7research.ru

    Why clients choose our CRO in Pharma

    X7 Research is a contract research organization (CRO) that provides a full range of services from consulting research, preparation of a registration strategy, planning and conducting pre-registration phases I-III clinical trials, post-registration studies (Phase IV, NIS) and pharmacovigilance. Our clients are local companies as well as top 20 pharmaceutical companies in the world. Our clients satisfied with the quality of the services provided and often come back with another clinical trials.

    ,,

    X7 Research’s primary responsibility is to help our clients bring medicines and medical devices to the pharmaceutical market in an efficient and safe manner. Our company is characterized by clients as an effective team that can work  in a short time and within the budget.

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

    Contact us

    Our Email: info@x7research.ru

    WHAT IS a Contract Research Organization (CRO) in pharma?

    CROs provide needed tools and programs to complete clinical trials efficiently and quickly. Using services of a contract research organization (CRO), the sponsor does not need to hire a full-time CTA and other staff, as the CRO can provide its own, which saves the research budget. 
    A sponsor of a clinical trial is an organization that needs to conduct clinical trials within the applicable law. For many companies, it is more profitable and convenient to purchase CRO services under a specific project contract, on a contractual basis, project by project. It is beneficial for the CRO and the sponsor to cooperate in clinical trials, since the CRO can take on all the responsibilities for bringing the drug to the pharmaceutical market.
    Services may vary depending on the type of a drug or a medical device, the number of volunteers needed in the centers, what is specifically required for research, the therapeutic area of ​​a drug, dosage form, and so on.
    A contract research organization (CRO) that provides a range of services depending on the CRO: its size, specialization, therapeutic area, and whether they conduct early and late phase clinical trials, offer pharmacovigilance, registration services, etc.. Also, in the world there is a practice of opening the so-called preclinical CRO, providing services for preclinical studies.

    What Does A CROs Do In Pharma Industry?

    Contract research organizations (CROs) are companies that provide services in the field of clinical trials, focusing on conducting research within the established budget, respecting the timelines of studies. X7 Research is a CRO that offers a full range of research services for your organization in Russia and the EAEU near you.

    OUR SERVICES

    Group 11

    Registration strategy & consulting

    Registration strategy & consulting

    – Research and analysis data

    – Development of a strategy for the registration of drugs and medical devices in the pharma

    – Study feasibility of clinical trials

    – Choosing a vendor according to your research

    – Budgeting in advance of any clinical trial for better study design

    X7 Research has extensive experience in searching and analyzing information on specific medicines in various therapeutic areas in order to prepare a strategy for registering medicines. The registration department of X7 Research will offer you the best variant of drug registration according to Russia, EAEU requirements. The scientific department will also study the possibility of registering a medicinal product based on literature reviews of preclinical and clinical trials.

    Post-authorization clinical studies

    – Phase IV studies

    – Non-interventional studies

    – Post-authorization safety study

    X7 Research offers a full range of services for the post-marketing stage of the drug life cycle. Our company is ready to conduct both large-scale studies to obtain large volumes of real data (RWD) and small-scale exploratory studies for your project. 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

    Pharmacovigilance remains one of the most important parts of conducting a clinical trial. That is why our CRO offer a full range of pharmacovigilance services.

    Clinical trials

    – Development of medical documentation and biostatistics

    – Monitoring your clinical research

    – Data management

    – Patient home visit 

    – Bioequivalence study

    – Therapeutic equivalence studies

    Our CRAs verify that the rights and well-being of subjects are protected, that the data provided is accurate, complete, and supported by primary documentation, and that research is conducted in accordance with the approved current version of the protocol/amendments, GCP, and regulatory requirements. The CRA training system in the company allows them to train high-quality personnel and constantly improve their skills.

    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 company provides services for state registration, modification of a registration dossier, confirmation of state registration of domestic, foreign, original, and reproduced medicines in the territory of the Russia and the EAEU. X7 Research knows how to make sure that all stages of a drug registration are completed without complaints from regulatory authorities. For more than 12 years we have been successfully working with clients from different countries together, including the top 20 CROs in the pharmaceutical industry.

    START A PROJECT WITH X7 RESEARCH

    Our email: info@x7research.ru

    Our goal is to continuously research, improve and deliver safe and quality clinical trials for our clients, guided by your clinical trial duration and your budget. X7 Research is a trusted testing partner for challenging regulatory environments and a tough economy.

    Contract Research Organization Roles and Responsibilities

    Clinical compliance with regulatory guidelines is critical and adherence to Good Clinical Practice (GCP) standards. CROs play the role of a central hub, connecting many parties in clinical trials. Often CROs interact with each other and cooperate on joint projects, as is done in the top CROs in California.

    Clinical compliance with regulatory agency guidelines is crucial and adhering to Good Clinical Practice (GCP) standards.      CROs role as the trial’s central hub connecting the sponsor with other stakeholders such as regulatory agencies, ethics committees, vendors, hospitals, etc.

    OUR PURPOSE

    CRO’s primary responsibility is to help our customers to bring medicines and devices to market safely and efficiently. We have been a trusted partner in clinical research since 2010. We have extensive experience in clinical trials, market analysis, market access consulting. We are ready to take on the most interesting and extraordinary projects.

    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 X7 RESEARCH

      Outsourcing to a Contract Research Organization can bring multiple benefits to pharma companies.

      Time Savings

      Working with a CRO to conduct a clinical trial significantly reduces the time required compared to do the trial in-house, as the CRO has experience with documentation, routine testing, and a faster process for writing key documents: investigator brochure, trial protocol, and others.

      In addition to the accumulated experience, CRO has the necessary software, established contacts with the centers, in order to quickly recruit volunteers in the research centers.

       

      Trials Cost Savings

      When a sponsor uses the services of a CRO, significant savings can be made on outsourcing personnel in the pharmaceutical industry. This saves the research budget. Because you do not need to hire staff on a permanent basis.

      X7 Research offers staff outsourcing for your specific clinical trial, reducing the cost of personnel in the pharmaceutical industry.

       

      Advanced Technological Needs

      Working with CRO provides hiring companies with access to the most advanced technologies and systems for data management, product development, research analysis and other clinical research services in any field of pharmacy.

      CRO has advanced IT solutions, automated control over documentation, which can significantly reduce the time of research.

      Evolving and Complex Regulatory Requirements

      Regulatory authorities require complex and precision information from sponsors to validate and control the quality of pharmaceutical clinical trials. CROs work within a clinical compliance framework on a daily basis, which gives them detailed knowledge of regulatory requirements and audits such as Good Clinical Practice (GCP) audits.

      CROs work with hiring organizations to optimize audit results by carefully reviewing any previous nuances of the study, following the current protocol.

      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 Trials?

      The CRO is the organization that plans, develops, and coordinates the clinical trial protocol. It then performs this protocol in accordance with the rules of the regulatory body and GCP standards. The sponsor hires a research organization under contract to perform the time-consuming and resource-intensive work required for a clinical trial. The sponsor can ca be attracted by the experience of the CRO. Because they are running one clinical trial after another so many times and so they  can anticipate potential delays and pitfalls and avoid them in advance. An important advantage of CRO is the presence of a scientific department, where specialists develop all documentation according to the therapeutic area of research.

      What is a contract research organization in Clinical Trials in pharma?

      The CRO is a contract research organization that plans, develops and coordinates the validity of the processes for conducting a clinical trial according to a trial protocol. It then performs this protocol in accordance with the rules of the regulatory body and GCP standards. Also, an integral part of the work of the СRO is the work with the principal investigators of the centers and with patients.

      A sponsor — who might have many potential treatments they wish to test them via clinical trial — engages a contract research organization to take care of the time-consuming and resource-intensive work required of a clinical trial. The sponsor is able to leverage the expertise of the CRO, which due to the CRO’s repeated execution of trial after trial, comes to be able to anticipate potential delays and pitfalls, avoiding them ahead of time.

      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 are a wide variety of CROs. CROs vary in size, some have large government research commissions, some operate internationally, and some are small local organizations. CROs are also differed in therapeutic areas, the number of services, and etc.

        Comparing one CRO to another can be very difficult, as CRO budgets and services often vary significantly from one company to another. When choosing a CRO, look at the company’s previous experience, including the types of projects completed, the clients they have worked with, any niche services they provide, as well as their overall track record in the industry. Also, an important part of the work of a contract research organization is work in various therapeutic areas.

        Sponsor’s Responsibility

        A business, organization, or institution may outsource any or all of its clinical trials and research responsibilities to a Contract Research Organization, but the responsibility remains with the original company that hired the CRO. Therefore, the sponsor is responsible for the safety of the investigational product in clinical trials.

        The quality and integrity of the clinical research data continue to reside with the entity sponsoring the work. CROs should be backed by a spotless track record of quality assurance and quality control to be competitive with other organizations.

        Get It In Writing

        Clinical research is very expensive, which is why medical records must be very clear about which organizations are responsible for each aspect of medical research, development, or other clinical services. Responsibility for any services or components not specified in the agreement remains with the sponsor, i.e. the organization hiring the CRO.

        It should be very clear which organization is responsible for each aspect of medical research, development, or other services. It is important to adhere to generally accepted medical terms.

        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 similar to 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 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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