Our contract research organization can help in:
- research and consulting in the process of drug development
- conducting high-quality clinical trials phase I-IV
- clinical trial feasibility checklist
- 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
- research site feasibility
- nursing service
Our contract research organization (CRO) provides a systematic approach to solving clinical trials and clinical trial feasibility
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, clinical trial feasibility assessment, planning and conducting pre-registration phases I-III clinical trials, medical writing, post-registration research (Phase IV, NIS) and pharmacovigilance. We are 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?
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. X7 Research provides a full range of patient recruitment feasibility assessments, comprehensive information promptly as requested by the Sponsor, to develop and improve the entire clinical research industry. X7 Research understands the complexity of assessing clinical trial feasibility, so it continually follows the above algorithm and provides all necessary information within the specified timeframe.
Registration strategy & consulting
– Registration strategy & consulting
– Data search and analysis
– Registration strategy development
– site feasibility in clinical trials
– Vendor selection
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. We have strong feasibility system. By timely and effective assessment of recruitment feasibility, not only the sponsoring companies, but all project participants benefit.
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.
– Building a system of pharmacovigilance
– Safety in clinical trials
– A Pharmacovigilance audit
– A 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 and study feasibility before clinical trial, 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.
– Development of medical documentation and biostatistics
– Monitoring of clinical trials
– Outsoursing CRAs
– Data management
– Patient home visit
– Bioequivalence study of clinical trial
– Therapeutic equivalence studies
X7 Research team is always trying to find individual solutions for each clinical trial and each partner. Our partners note the work of the CRAs in terms of conducting visits to research centers, as well as the high qualification of our specialists
– Audit of the registration dossier
– Bringing the registration dossier in compliance with the requirements
– Conversion of the 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 for our company is to 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, clinical trial site feasibility 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
A CRO is responsible for planning, setup, and day-to-day execution, management of a clinical trial. Handling and supervising the technical — data collection and medical testing aspect.
Clinical trial site feasibility is important before clinical trials start. Clinical compliance is critical, as is adherence to Good Clinical Practice (GCP) standards.
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 to bring medicines and medical devices to the market efficiently and safely. We help clients to 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.
Working with a CRO to conduct research is 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 and clinical trials feasibility 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
There are significant cost savings in hiring a CRO. The team in the contract research company (CRO) is already formed.
So you do not need to hire additional staff for clinical research.
Working with CRO gives hiring companies access to the most advanced technologies and systems for a data management, a product development, study feasibility, research analysis, innovative IT-technology solutions and other clinical trial 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, for example, to conduct study feasibility.
Therefore, sponsor audits are often carried out for organizations, which X7 Research always passes.
Let’s check some X7 Research figures
years of experience
of international clients
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?
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?
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 and study feasibility.
How X7 RESEARCH company works
Conducting a gap analysis
Preparing a drug registration strategy
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 and quality for study feasibility of clinical trial. 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.
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 the sponsor.
CROs should be backed by a spotless track record of quality assurance and quality control of clinical trial and study feasibility before clinical trial would start.
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.
All of them make up a fast-growing segment of the pharmaceutical industry. Outsourcing of specialized clinical research and clinical trial and manufacturing activities continues to grow in all countries as organizations strive to meet the needs of an evolving industry.
START A PROJECT WITH X7 RESEARCH
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 for sponsor’s clinical trial. A contract research organization may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, contract research, clinical trial, study feasibility, 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, registration and conducting clinical trial in Russia, EAEU, CIS, and EU
X7 Clinical Research is a modern center specializing in conducting clinical trial 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 and clinical trial, bringing outsourcing solutions to the Pharmaceutical, Drug, Biological and Device Industry. Design of study documents, selection and management of investigational sites, study feasibility, subject recruitment, project management and monitoring.
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