Our contract research organization can offer a full range of services, including:
- research and consultation in the process of drug development for further clinical trials
- conducting clinical trials at different phases, including both early and late phases
- registration, introduction of changes in the registration dossier to the regulatory authorities
- post-marketing of the drug
- organization of the pharmacovigilance system, preparation of periodic reports and maintenance of other documentation
- home care services
X7 Research puts a lot of effort to provide its’ clients with the best services in clinical trials
Why clients choose our CRO
X7 Research is a contract research organization (CRO) providing a full range of services from consulting, research, preparation of a registration strategy, planning and conducting pre-registration phases I-III clinical trials, post-registration studies (Phase IV, NIS) and pharmacovigilance. Work in X7 Research is based on the principles of the highest quality. GCP standards are our core values. In addition, we adhere to the transparency of all internal processes at all levels. Our clinical development is constantly improving, we also have a plan for the development of the department.
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?
Organizations (CROs) – are companies that conduct clinical trials and provide research support services in various therapeutic areas, for example, cardiology, oncology, neurology, hematology, dermatology, ophthalmology and others and continue their clinical development systems.
Registration strategy & consulting
– Registration strategy & consulting
– Data search and analysis
– Registration strategy development of drugs and medical devices
– Study feasibility
– Vendor selection depending on the project
– Clinical trials budgeting
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. X7 Research is a reliable partner for challenging regulatory environments and a tough economy.
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. Our company is ready to conduct both large-scale studies to obtain big amounts of real-world data (RWD) and small-scale exploratory studies. The X7 Research company team is ready for any challenge and the most ambitious projects according to our clinical development system.
– 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, from individual consultations to complete pharmacovigilance. With a strong experience X7 Research offers a full range of FV services in the EAEU that enable you to meet the pharmacovigilance requirements of the market. Our PV specialists carry out high-quality documentation of PSUR, DSUR and others.
– Development of medical documentation and biostatistics
– Data management
– Patient home visit
– Bioequivalence study
– Therapeutic equivalence studies
The X7 Research team always tries to find individual solutions for each partner and each clinical trial according to the therapeutic area of research. X7 Research has been conducting monitoring visits since 2010, both on-site and remotely in Russia, EAEU, CIS, EU. The strength of our specialists’ work is the implementation of thorough data control, as well as constant interaction with the client. Also, we continue to improve your clinical development system
– 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 state registration, modification of a registration dossier, confirmation of state Registration of domestic, foreign, original, and reproduced medicines on the territory of the Russian Federation and the Eurasian Economic Union. Contract research company X7 Research provides qualified assistance in the registration of medicines. Specialists of X7 Research can advise the client at all stages of the registration of a medicinal product in accordance with our clinical development system. Employees of X7 Research can conduct a qualitative analysis of the dossier for compliance with all regulatory requirements. After the review, the client receives recommendations for each section of the registration dossier, which further helps to minimize the risks of submitting the registration dossier to the regulatory body.
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Our goal is to conduct research activities, explore the potential of young professionals and provide quality services to partners and clients of clinical trials, include consultations, registrations, monitoring and other services in accordance with our clinical development system.
Contract Research Organization Roles and Responsibilities
The CRO is responsible for the planning, setup, routine execution, and management of clinical trials. Also, an important part of the work of the organization is the processing and control of the technical aspects of data collection and medical testing, this function in X7 Research is performed by the data processing department with the clinical development.
Clinical compliance with regulatory guidelines is critical and adherence to Good Clinical Practice (GCP) standards. In summary, CROs play the role of a bridge between the sponsor, regulators, ethics committee, vendors, hospitals, researchers, and other stakeholders. With the participation with CRO in a clinical trial, in addition to saving the budget, the involvement of the company in clinical trials allows sponsors not adding to the staff.
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 as a contract research company is to help our clients bring medicines and devices to market efficiently and safely, at short notice and with significant reductions in research budgets. We are a reliable partner in clinical trials since 2010. Our clinical development system helps partners complete trials quickly and efficiently.
X7 Research can help in the strategy development of interventional studies, preparation of literature reviews, preparation of post-marketing and non-interventional study concepts. Our medical writers have extensive experience in developing clinical development documents. We will help in the selection of the study endpoints, justification of the required sample size, and selection of correct statistical methods for the analysis of the efficacy and safety parameters of the investigational product.
BENEFITS OF OUTSOURCING TO A CRO
Outsourcing to a Contract Research Organization can bring multiple benefits to clinical professionals and institutions.
Working with a CRO to conduct a trial often significantly reduces the time it takes compared to completing the trial in-house.
An important addition is the possibility of remote visits, which is especially important in the context of Covid-19. Our clinical development system is always improving and expanding.
Trials Cost Savings
By hiring a CRO, you can save a lot on your clinical research budget. By itself, a faster litigation offers healthcare providers cost savings, such as hiring staff for a project or permanent job.
It is possible because of the clinical development plan.
Working with CRO gives hiring companies access to the most advanced technologies and systems for data management, product development, research analysis and other clinical research services.
IT capabilities, Internet applications and competent specialists are an important advantage of our company. This is what allows us to help accelerate clinical trials while maintaining comprehensive quality control within an evolving pharmaceutical industry.
Evolving and Complex Regulatory Requirements
Regulatory authorities require complex and accurate data to be approved and allowed to conduct clinical trials. CROs work within a clinical development plan framework on a daily basis, which gives them detailed knowledge of regulatory requirements and audits such as Good Clinical Practice (GCP) audits.
The work of the CRO optimizes the results of audits by carefully reviewing any previous issues, carefully reviewing the infrastructure, and adhering to current protocols.
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:
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?
The CRO is the organization that plans, develops, and coordinates the clinical trial protocol. A contract research organization helps to conduct clinical trials for a sponsor of one or more drugs or medical devices according to a clinical development plan. The sponsor can use the experience of the CRO.
Through a retrial conducted by the CRO, who can anticipate potential delays and gaps in litigation and avoid them in advance.
How X7 RESEARCH company works
Conducting a gap analysis
Preparing a drug registration strategy
Selecting a CRO
There is a wide variety of CROs. Some of them are large state-owned companies with a global reach and a wide range of comprehensive services, while other CROs are small private companies specializing in a particular therapeutic area and their clinical development plan template.
Comparing one CRO to another can be very difficult, as CRO budgets and services often vary significantly from one company to another. So, companies offer a certain range of services and specialization, while others offer a full range of services for customers. When choosing a CRO, look at the company’s previous experience, including the types of projects they’ve completed, the clients they’ve worked with, any niche services.
Organizations often outsource any or all of their clinical trials and research responsibilities to a CRO, but the responsibility remains with the original company that hired the CRO.
The quality and integrity of clinical trial data remain with the sponsoring organization. That is why CRO should provide quality work in accordance with government requirements of GCP and other.
Get It In Writing
When hiring a CRO, always ensure each delegated task is outlined in writing and signed by both parties. All agreements should be thoroughly documented by all of the involved parties to avoid any costly misunderstandings or complications.
It should be very clear which organization is responsible for each aspect of the medical research, development, or other clinical services. It is important to clarify all the nuances and details before the study to avoid misunderstandings.
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 like 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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