Our contract research organisation can help in:
- consulting in the process of drug and medical devices in the area of clinical trials
- providing and supporting clinical trials
- registration, modification of registration dossier etc.
- post-marketing clinical trials of the drug and medical devices
- well organised pharmacovigilance system
- home care service for our clients
X7 Research is a contract research organization that provides a high-quality systematic approch to solving any issues in clinical trials from consulting, conducting research, preparing a registration strategy, planning, conducting pre-registration phases I-III clinical trials, marketing studies (Phase IV, NIS) and pharmacovigilance.
Why clients choose our CRO
X7 Research company is a contract research organisation that provides a full range of services. We are highly experienced in conducting clinical trials, consulting of market access. X7 Research is a reliable partner for the trials in challenging regulatory environment and tough economy.
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?
What Does A CROs Do?
Contract Research Organisations (CROs) – are companies that conduct clinical trials and provide research support services of biotechnology, medical devices, and the pharmaceutical industry. For the qualitative conduct of clinical trials CROs team needs to study of all current regulatory documentation in the country that is required. Also an extensive experience is impotant for supporting clinacal trials in various therapeutic areas .
OUR CROs SERVICES
Registration strategy & consulting
– Data search and analysis
– Registration strategy development
– Study feasibility
– Remote Vendor audits
– Estimation of cost and timing drug development
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.
Post-authorization clinical studies
– Phase IV studies
– Non-interventional studies
– Post-authorization safety
The X7 Research team has extensive experience in conducting post-marketing studies in Russia, EAEU, CIS, EU. We work by the most current legislative requirements of drug circulation. We offers a wide range of services in the post-marketing phase of the drug lifecycle.
– Building a system of pharmacovigilance
– Safety in clinical trials
– Pharmacovigilance audit
– Pharmacovigilance contact person
X7 Research provide PV services since 2010. Our clients are local companies as well as Big Pharma. Our experts have a lot of experience in this field and have compliance with all regulatory requirements. This is our main advantage.
– Development of medical documentation and biostatistics
– Monitoring services
– Data management services
– Patient home visit
– Bioequivalence study
– Therapeutic equivalence studies
-Outsoursing CTAs for your project
X7 Research team are always trying to find individual solutions for each clinical trial and each partner.
X7 Research has developed a well-functioning system for preparing CRAs and individual trainig plan, which includes:
- individual plan GCP training,
- project training,
- joint visits,
- personal growth trainings.
– 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 registration dossier, confirmation of state registration of domestic, foreign, original, and reproduced medicines.
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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 Organisation Roles and Responsibilities
The CRO is responsible for the planning, setup, and day-to-day execution and management of a clinical trial. Processing and supervision of the technical aspects of data collection and medical testing. The contract organisation helps the sponsor quickly and efficiently bring the drug to the market.
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.
We help organizations trade with integrity and trust
We ensure safety in everyday life, at home and at work
We help new technology to reach consumers quickly
X7 Research’s primary responsibility is to help our clients bring medicines and medical devices to market efficiently and safely. We have worked with different studies such as first on human, innovative drugs, complex I phases, including oncology, vaccines. We also completed more than 70 projects in Bioequivalence studies.We have been a reliable partner in clinical trials since 2010.
BENEFITS OF OUTSOURCING TO A CRO
Outsourcing to a Contract Research Organization can bring multiple benefits to pharmaceutical organizations, biotechnology companies and other participants in the pharmaceutical market.
Working with a CRO to conduct a trial often significantly reduces time it takes compared to completing the trial in-house.
CROs already have all the necessary tools and resources, as well as a team of experts with experience in specific therapeutic areas, with knowledge in regulatory compliance.
Trials Cost Savings
By hiring a CRO, you can save a lot on your clinical research budget. A faster trial process alone offers medical institutions a reduction in costs.
You don’t need to hire staff like CTA for routine monitoring, especially when it’s not needed during the year and on a permanent staff.
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 often change fast and in this regard, 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, which 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
years of experience
of international clients
X7 Research company is a contract research organization 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:
During our partnership, we have jointly completed over 10 projects. The projects covered a variety of tasks, such as writing of medical documentation, conducting all types of monitoring visits, preparation of a final clinical trial report. All tasks were accomplished in time, the patient enrollment at the site followed the schedule, and the work provided was at a high-quality level.
In the course of our partnership, we valued the high level of provided services, responsibility, and professionalism of the team. During the collaboration period, X7 Research was proven to be a responsible and trustworthy partner.
What is a contract research organisation in Clinical Trials?
What is a contract research organisation in Clinical Trials?
A CRO is the entity that plans, develops, and coordinates the clinical trial protocol. Then, it executes that protocol in accordance with regulatory agency rules and GCP standards.
The sponsor, who may have many potential treatments that they would like to test in clinical trial, hires a contract research organization. It is necessary to perform time-consuming and resource-intensive work for a clinical trial. The sponsor may use the experience of CRO which due to the CRO’s repeated CRO testing.
How X7 RESEARCH company works
Conducting a gap analysis
Preparing a drug registration strategy
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 areas.
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 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.
A pharmaceutical company, biotech organization, or pharmaceutical marketplace may outsource any or all of its clinical trial and research responsibilities to a Contract Research Organization, but the responsibility remains with the original company that hired the CRO.
The quality of clinical trial data remains with the sponsoring organisation. CROs must have an excellent track record of quality assurance and quality control of any clinical trial.
Get It In Writing
When hiring a CRO, always make sure that each delegated task is in writing and signed by both parties in full. All agreements must be carefully documented by all parties involved to avoid costly misunderstandings or complications during clinical trials between organizations.
It should be clear which organisation is responsible for each aspect of medical research, development or other clinical services, such as registration, signing of periodic reports on clinical trials (PSURs). 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.
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.
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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.
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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