Looking for suitable Contract Research Organization?

Looking for suitable Contract

Research Organization?

X7 Research has been a reliable partner in the field of clinical trials, registration of medicines and medical devices, pharmacovigilance since 2010. X7 Research is a contract research organization (CRO) providing a full range of services at all stages of drug development and registration in Russia, EAEU, CIS and EU with Big Pharma. It is also worth mentioning that the company carries out clinical trials in all phases in pharma, including post-marketing, and conducts home visits.

Our contract research organization (CRO) can help in:

  • consulting in the process of clinical trials for drugs and medical devices
  • providing and supporting clinical trials with Big Pharma and local companies
  • registration, modification of a registration dossier
  • a post-marketing phase of clinical trials
  • a high-quality and well-functioning pharmacovigilance system
  •  Nursing service

X7 Research is a contract research organization (CRO) that provides a high-quality systematic approach to solving any issues in the pharmaceutical market from consulting, conducting research, preparing a registration strategy, planning, and conducting pre-registration phases I-III clinical trials, post-registration studies (Phase IV, NIS) and pharmacovigilance.

Do you need more infromation about clinical trials in CRO?

    Why clients choose our CRO

    X7 Research is a contract research organization (CRO) providing a full range of services to the market with Big Pharma and with local pharmaceutical companies. We have extensive experience in conducting clinical trials I-IV phases, conducting market analysis, advising in the field of market access. X7 Research is a trusted testing partner for challenging regulatory environments and a tough economy.

    X7 Research’s primary responsibility is to help our clients to bring medicines and devices to the market efficiently and safely in the shortest possible time.

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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.

    WHAT IS Contract Research Organization (CRO)?

    CRO is a team with extensive experience in clinical research. It is the experience and accumulated knowledge that help to effectively, efficiently and on time complete a clinical trial. Thus, the sponsor does not need to hire full-time staff, while saving on clinical research costs.
    With a strong local expertise and focus on quality X7 Research ensures that clinical trials and drug registrations are completed on time and within budget.
    In clinical trials, the sponsor is an organization or a person that needs to conduct the clinical trial. They hire a CRO for a specific drug or medical device project on a contract basis – project by project.
    Most of the contract research organizations (CRO) that provide clinical research services provide it to pharmaceutical, biotechnology, medical devices and drug manufacturers and conducts clinical research in various therapeutic areas, including oncology, vaccines, ophthalmology, cardiology and many others

    What Does A CROs Do?

    Contract Research Organizations (CROs) are companies that conduct clinical trials and provide research support services in the biotechnology, medical devices, and pharmaceutical industries under applicable law. CROs between regulators, research sponsors, medical centers, clinicians and researchers, and patients.

     

     

    OUR SERVICES

    Group 11

    Registration strategy & consulting

    – Data search and analysis

    – Development of a registration strategy

    – Exploring a possibility

    – Remote an audit of suppliers

    – Estimation of the cost and terms of drug development

    – Studies feasibility

    Employees of X7 Research scientific department have extensive experience in searching and analyzing information on specific medicines to prepare a strategy for registering medicines in Russia, the EAEU, the CIS, the EU.

    Post-authorization clinical studies

    – Phase IV studies

    – Non-interventional studies

    – Post-authorization safety

    X7 Research team has 12-year experience in conducting post-marketing research in Russia, the EAEU, the CIS, and the EU. We work according relevant legislative requirements in the field of medicines circulation. We offer a wide range of services at the post-marketing stage of the drug life cycle.

    Group 15

    Pharmaco-vigilance

    – Building a system of pharmacovigilance

    – Safety in clinical trials

    – Pharmacovigilance audit

    – Pharmacovigilance contact person

    X7 Research has been providing pharmacovigilance services since 2010. Our clients are local companies as well as Big Pharma. Our specialists have extensive experience in this field, and we work according to all regulatory requirements. We always make all annual reports on time: DSUR, PSUR and others.

    Clinical trials

    – Monitoring services

    – Data management services

    – Patient home visit

    – Bioequivalence study

    – Therapeutic equivalence studies

    – Outsourcing CTA for your project

    X7 Research team always tries to find individual solutions for each clinical trial and each partner. Specialists of the clinical department have experience in conducting monitoring in sites. They are regulatory trained to improve their skills in the area of clinical trials.

    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 knows how to ensure that all stages of drug registration are passed without any claims from the regulatory authorities. For 11 years we have been successfully working with clients from different countries. Our company provides services for state registration, modification of a registration dossier, confirmation of a state registration of domestic, foreign, original, and reproduced medicines.

    START A PROJECT WITH X7 RESEARCH

    Our goal is to conduct research activities, provide high-quality support for clinical trials and expand the development prospects of both employees and the pharmaceutical industry at the global level.

    Contract Research Organization Roles and Responsibilities

    The CRO is responsible for design planning, clinical trial alignment, routine execution, and clinical trial management. CROs are also involved in processing and control of the technical aspects of the data collection and medical testing, as well as control of the study documentation in accordance with the law. The contract organization helps the sponsor quickly and efficiently to bring the drug or medical device to the market.

    Clinical compliance with regulatory agency guidelines is crucial and adhering to Good Clinical Practice (GCP) standards. CRO as the trial’s central hub connecting the sponsor with other stakeholders such as regulatory agencies, ethics committees, vendors, hospitals, etc. Also, CROs often cooperate with each other, for example, in Dallas, Texas.

    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 bring medicines and medical devices of our clients to the market in an efficient and safe manner, which saves a significant amount of research budget and time. We have worked with different studies, such as the first in humans, innovative drugs, complex phase I, including oncology, vaccines. We have also completed over 70 bioequivalence projects in the last 3 years. 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 pharmaceutical organizations, biotechnology companies and other participants in the pharmaceutical market.

    Time Savings

    Working with a CRO to conduct a test often greatly reduces the time required compared to completing the test yourself.

     

    This is because CRO have already had all the necessary tools and resources, IT capabilities, and a team of experts with experience in specific therapeutic areas.

    Trials Cost Savings

    By hiring a CRO, you can save a significant portion of your clinical research budget on staff. By itself, faster offers cost savings to healthcare providers.

     

    You don’t need to hire employees like CTA for routine monitoring, especially when it’s not needed during the year, as permanent staff.

     

    Advanced Technological Needs

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

    Clinical research is a rapidly changing industry. It is essential that software and hardware IT capabilities, as well as Internet-based applications, are the best in the industry to facilitate the acceleration of clinical trials while maintaining comprehensive quality control.

    Evolving and Complex Regulatory Requirements

    In the field of clinical trials, registration and pharmacovigilance regulatory requirements change often fast. It is necessary to constantly change one’s own policy in order to conduct high-quality clinical trials. CROs work within clinical compliance on a daily basis, that gives them intricate knowledge of regulatory requirements and audits such as Good Clinical Practice (GCP) audits.

    CROs work with hiring companies to optimize 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

    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 to registration, post-registration studies (Phase IV, NIS) and pharmacovigilance.

    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?

    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 to registration, post-registration studies (Phase IV, NIS) and pharmacovigilance.

    The sponsor, who may have many potential treatments that they should test in clinical trials, hires a contract research organization (CRO). It is necessary to perform time-consuming and resource-intensive work for a clinical trial.   

    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 wide variety of CROs that specialize in different aspects of clinical research. Some of them are large state-owned companies with a global reach and a wide range of integrated services, while other CROs are small private companies specializing in a specific area, such as registration, pharmacovigilance and other.

    Comparing one CRO to another can be very difficult, as CRO budgets and services often vary significantly from one company to another. Also, some contract research organizations (CROs) specialize in different therapeutic areas. 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.

    Sponsor’s Responsibility

    A pharmaceutical or biotechnology organization may outsource some or all of its clinical trial and research responsibilities to a contract research organization (CRO), but the responsibility remains with the original company that hired the CRO.

    The quality of clinical trial data remains with the sponsoring organization. That is why every CRO should provide quality services in the field of clinical trials in order to stay ahead of the competition in the pharmaceutical market.

    Get It In Writing

    When hiring a CRO, you should always make sure that every delegated task is in writing and signed by both parties to avoid future misunderstandings. Each nuance should be provided in the documentation on both sides. All agreements should be carefully documented by all parties involved to avoid costly misunderstandings or complications during projects between organizations.

    It should be clear which organization is responsible for each aspect of medical research. Responsibility for any services or components not specified in the agreement remains with the hiring organization.

    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.
    All of them make up a fast-growing segment of the biotechnology and pharmaceutical industry within the pharmaceutical market with Big Pharma and local small companies. Outsourcing of specialized clinical research and manufacturing work continues to evolve as organizations strive 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.

    CONTACT US

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