Looking for suitable Contract Research Organization?

Looking for suitable Contract

Research Organization?

X7 Research is a reliable partner in clinical trials, registration drugs and medical deviсes, pharmacovigilance, a wide range of services in the post-marketing phase of the drug lifecycle since 2010. Our company is a contract research organization (CRO) proposing a full range of research services at all stages of the development and registration of medicines and devices in Russia, the EAEU, the CIS and the EU.

Our contract research organization can help in:

  • research and consulting in the process of drug development
  • research and consulting in the process of drug development
  • conducting high-quality clinical trials phase I-IV
  • registration of drugs, assistance in compiling and changing the registration dossier
  • post-marketing of the drug
  • organization of a pharmacovigilance system, maintaining documentation within the legislation
  • nursing service

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

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    Why clients choose our CRO

    X7 Research is a contract research organization (CRO) with a large team of highly qualified specialists providing a full range of services from consulting, research, preparation of a registration strategy, planning and conducting pre-registration phases I-III clinical trials, medical writing, post-registration research (Phase IV, NIS) and pharmacovigilance. Our advantage is that we offering a full range of services.

    We can do all services in clinical trials in house – that’s our main advantage.

    ,,

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

    WHAT IS Contract Research Organization?

    A CRO provides research services to pharmaceutical, biotechnology and medical devices companies for further drug registration. Services can range from drug discovery to drug commercialization, pharmacovigilance, and post-registration studies. 
    Within clinical trials, a sponsor (the organization seeking to investigate the safety and effiсiency of a new treatment) hires a CRO to a specific project contract, on a contract, project-by-project basis.
    An important part is post-marketing research. A clinical trial sponsor hires the CRO to fulfill a contract for a particular drug or group of drugs or medical devices. Our company is also distinguished of an individual approach to each specific clinical trial.
    A contract research organization range of clinical research services to (CRO) provides research services to pharmaceutical, biotechnology, and medical device companies.

    What Does A CROs Do?

    Contract Research Organizations (CROs) are companies that conduct clinical trials for a sponsor and provide research support services to pharmaceutical, biotechnological and other organizations.

    OUR SERVICES

    Group 11

    Registration strategy & consulting

    – Data search and analysis

    – Registration strategy development

    – Study feasibility

    – Vendor selection

    – Budgeting

    X7 Research has extensive experience in searching and analyzing information on specific medicines to prepare a strategy for the registration of medicines and medical devices in Russia, the EAEU, the CIS, the EU.

    Post-authorization clinical studies

    – Phase IV studies

    – Non-interventional studies

    – Post-authorization safety

    X7 Research offers a wide range of services in the post-marketing phase of the drug lifecycle. X7 Research is ready to conduct both large-scale studies to obtain big amounts of a real-world data (RWD) and small-scale exploratory studies. A post-marketing research should also be carried out in accordance with applicable law. 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 in pharmacovigilance, X7 Research offers a full range of FV services in the EAEU that enable you to meet pharmacovigilance requirements of the market. Our pharmacovigilance specialists carry out high-quality documentation of PSUR, DSUR and others.

    Clinical trials

    – Development of medical documentation and biostatistics

    – Monitoring

    – Outsoursing CRAs

    – Data management

    – Patient home visit

    – Bioequivalence study

    – Therapeutic equivalence studies

    X7 Research team is always trying to find individual solutions for each clinical trial and each partner. Our partners note work of the CRAs in terms of conducting visits to research centers, as well as the high qualification of our specialists.

    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 the 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 countries. The area of interest of our company is work with the registration of medical devices according to the rules of the EAEU. Now this is relevant for certain medical devices of class 2b, 3 and implanted staff.

    START A PROJECT WITH X7 RESEARCH

    Our goal is to conduct research activities, provide quality services for partners in the field of clinical trials, pharmacovigilance and registration of medicines and medical devices. Our priority is the development of the pharmaceutical field and young professionals.

    Contract Research Organization Roles and Responsibilities

    The CRO is responsible for the planning, a routine execution, and a management and design of a clinical trial. An important part is the processing of information during the study, a review of the technical aspects of a data collection and medical testing. 

    Clinical compliance is critical, as is adherence to Good Clinical Practice (GCP) standards

    OUR PURPOSE

    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

    X7 Research’s primary responsibility is to help our clients to bring medicines and medical devices to the market efficiently and safely. We help clients work within tight budgets and deadlines. We have been a reliable partner in clinical trials since 2010.

    BENEFITS OF OUTSOURCING TO A CRO

    Outsourcing to a Contract Research Organization (CRO) can bring multiple benefits to clients in pharma.

    Time Savings

    Working with a CRO to conduct research is often greatly reduced time required compared to completing the test in-house. CRO has already had all the necessary tools and resources, the team of professionals in the field of clinical research in various therapeutic areas.

    The accumulated experience in our company, the system of SOPs and an individual approach significantly reduces the time for conducting research.

     

    Trials Cost Savings

    The team in the contract research company (CRO) is already formed, so you do not need to hire additional staff for clinical research.

    You don’t need to hire personnel, especially when they are not needed during the year.

    Advanced Technological Needs

    Working with CRO gives hiring companies access to the most advanced technologies and systems for a data management, a product development, research analysis, innovative IT-technology solutions and other clinical research services. Keeping up with the times is especially important in the fast-growing pharmaceutical industry.

    Evolving and Complex Regulatory Requirements

    Current legislation is constantly changing, that is why the competence of contract research organizations (CROs) includes constant local expertise. It is very important to follow Good Clinical Practice (GCP) to provide quality services to partners and clients.

    Therefore, sponsor audits are often carried out for organizations, which X7 Research always passes.

    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

    This is what our clients say about us:

    What is a contract research organization in Clinical Trials?

    What is a contract research organization in Clinical Trials?

    The CRO is the organization that develops the clinical trial protocol. It then performs this protocol in accordance with the rules of the regulatory body and GCP standards. The sponsor may use the experience of the CRO, the accumulated experience will avoid errors in the study and documentation, such as a registration dossier.

    A sponsor — who might have many potential treatments they wish to have tested 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

    Working with a CRO
    Group 17 (1)

    Selecting a CRO

    There is a variety of contract research organizations (CROs)  depending on the specialization of companies, its scale, the number of current projects. 

    When choosing an organization for a project, always pay attention not only to the cost of services, but also to previous experience. Also an important part is the specialization and therapeutic area of this СRO.

    Sponsor’s Responsibility

    A business, organization, or institution may transfer any or all of their clinical trials and research responsibilities over to a Contract Research Organization, but the responsibility remains with the original company hiring the CRO.

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

    Get It In Writing

    When hiring a CRO, always make sure that each delegated task is in writing and signed by both parties. This will avoid misunderstandings during the clinical trial. Responsibility for any services or components not specified in the agreement remains with the hiring organization. 

    Therefore, contract research organizations (CROs) should provide quality services to the sponsor to not undermine reputation.

    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 the CMO is in the development of a drug through to its manufacturing.

    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

    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.

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