Our contract research organization can help in:
- advising on clinical trials of medicines and medical devices
- provision and support of clinical trials for your medicinal product or medical device
- registration in accordance with the law, drafting and amending the registration dossier
- post-marketing phase of clinical trials of the drug and medical devices
- quality provision of pharmacovigilance services
- nursing service
X7 Research is a contract research organization (CRO) that provides an individual and high-quality approach to solving issues in the area of clinical trials from consulting, direct research, preparation of a registration strategy, planning and conducting pre-registration phases I-III clinical trials, post-registration studies (Phase IV, NIS) and pharmacovigilance.
Why clients choose our CRO
X7 Research is a contract research organization which provide a full range of services in clinical research in various therapeutic areas. We have extensive experience in clinical trials, market analysis, market access consulting since 2010. X7 Research is a reliable partner for challenging and ever-changing regulatory environments and a tough, volatile economy.
X7 Research’s primary responsibility is to help our clients bring medicines and medical devices to the market efficiently and safely on time and within your budget.
X7 Research’s company primary responsibility is to help our clients in bringing medicines & medical devices to the market efficiently and safely.
WHAT IS Contract Research Organization?
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. In order to conduct qualitatively clinical trials, the CRO team needs to study all the current regulatory documentation in the countries where the clinical trial is conducted. Our specialists have extensive experience in various therapeutic areas such as oncology, hematology, neurology, ophthalmology and others.
Registration strategy & consulting
– Data search and analysis
– Registration strategy development
– Study feasibility
– Vendor selection
The X7 Research team has extensive knowledge to prepare a drug registration strategy, prepare study budget, data management, research and select vendors.
Post-authorization clinical studies
– Phase IV studies
– Non-interventional studies
– Post-authorization safety
The X7 Research team has great experience in conducting post-marketing research in Russia, the EAEU, the CIS, and the EU. We work according to the most relevant legislations in the field of drug circulation within the country where clinical trials are taking place. We offer a wide range of services at the post-marketing stage of the drug life cycle, presented above.
– 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 large pharmaceutical companies. Our specialists have extensive experience in the field of registration and comply with all regulatory requirements within the law.
– Development of medical documentation and biostatistics
– Monitoring services trials
– Data management services in clinical trials
– Home care visits
– Bioequivalence study
– Therapeutic equivalence studies of clinical trials
-Outsoursing CTAs for your project
The X7 Research team finds customized solutions for each clinical trial and specific partner.
X7 Research has developed a well-functioning system for preparing CRAs and individual trainig plan, which includes:
- individual plan GCP training,
- project training in clinical trials,
- 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 the 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 clinical trials qualitatively for our sponsors, providing them with all the needed services. We are full-services CRO since 2010.
Contract Research Organization Roles and Responsibilities
The CRO is responsible for the planning, routine execution, and management of a clinical trial. Processing and enforcement of the technical aspects of data collection and medical testing during early and late phase trials. The contract organization helps the sponsor quickly and efficiently bring the drug to the market in the shortest possible time.
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, principal investigators, patients.
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 in the time-limited environment. We have worked with different studies such as first on human, innovative drugs, complex I phases, including oncology, vaccines. We have also completed more than 70 projects in Bioequivalence studies for 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 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 have already had all the necessary tools and resources, as well as a team of experts with experience in specific therapeutic areas, with knowledge in regulatory compliance. There are experienced specialists in the CRO team, whose work is significantly accelerated due to their deep knowledge.
Trials Cost Savings
By hiring a CRO, you can save a lot on your clinical research budget. A faster trial process 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. Our data management system allows you to significantly systematize the information obtained during a clinical trial.
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 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 organization in Clinical Trials?
What is a contract research organization in Clinical Trials?
X7 Research offers a full range of clinical trials services, which allows us to cover all aspects of bringing medicines and medical devices to the pharmaceutical market in a short time and within a budget. We are a reliable partner in unstable economic conditions and constantly changing pharmaceutical legislation.
A sponsor — who might have many potential treatments which need to be 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
Conducting a gap analysis
Preparing a drug registration strategy
Selecting a CRO
There are many 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 services, while other CROs are small private companies specializing in a specific area such as registration, pharmacovigilance, and other areas. It is important to understand that companies can also be divided according to their profile, there are companies that specialize in software support for clinical trials, some provide data management.
Comparing one CRO to another can be very difficult, as CRO budgets and services often vary significantly from one company to another. In addition, some contract research organizations specialize in different therapeutic areas, for example, X7 Research has extensive experience in conducting clinical trials in several areas at once.
Any companies that release drugs and medical devices of certain hazard classes to the pharmaceutical market may transfer part or all their responsibilities for clinical trials and research to a contract research organization. However, the responsibility for testing remains with the company that hired the CRO.
The quality of clinical trial data is also left to the sponsoring organization. CROs should be run great and smoothly work to ensure the quality of any clinical trial.
Get It In Writing
When you hire a CRO, always ensure that each delegated task is in writing and fully signed by both parties. All agreements should be carefully documented by all parties involved. This is necessary to avoid misunderstandings or complications during clinical trials between organizations.
All nuances and aspects should be clearly spelled out using established terms. It should be clear to organization that is responsible for each aspect of medical research, development, or other clinical services.
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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