Looking for suitable Contract Research Organization?
Looking for suitable Contract
Research Organization?
X7 research is a reliable partner in clinical trials, registration of drugs and medical devices, pharmacovigilance since 2010. Our company is a contract research organization offering a full range of research services of the development and registration of medicines and medical devices in Russia, the EAEU, the CIS and the EU. Clinical trials are an important part of drug circulation.
Our contract research organization can offer a full range of services, including:
- research and consulting in the process of drug development
- research and consultation in the process of a 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 regulatory authorities
- post-marketing of the drug
- organization of a 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
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Why clients choose our CRO
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. Our company is based on principles of the highest quality. GCP standards are our core values. Besides that, we adhere to transparency of all internal processes at all levels. Our SOPs system and QA are provided this level of processes quality. Audits both internal and external prove its’ effectiveness.
X7 Research’s primary responsibility is to help our clients bring medicines and devices to market in the pharmaceutical market efficiently and safely, as quickly as possible and within your budget.
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 various therapeutic areas, for example, cardiology, oncology, neurology, hematology, dermatology, ophthalmology, and others.
OUR SERVICES
Registration strategy & consulting
– Data search and analysis
– Registration strategy development
– Study feasibility
– Vendor selection
– 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.
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 a real-world data (RWD) and small-scale exploratory studies. The X7 Research team is ready for any challenge and the most ambitious projects.
Pharmaco-vigilance
– 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. With a great experience in pharmacovigilance, 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.
Clinical trials
– Development of medical documentation and biostatistics
– Monitoring
– 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 in compliance with the therapeutic area of a 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.
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 provides services for a state registration, modification of a 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. Contract research company provides qualified assistance in the registration of medicines. Specialists of X7 Research can advise a client at all stages of the registration of a medicinal product. Employees of X7 Research can conduct qualitative analysis of the dossier for compliance with all regulatory requirements. After a 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.
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 a work of the organization is the processing and control of technical aspects of a data collection and medical testing, this function in X7 Research is performed by the data management department.
Clinical compliance is critical, as is adherence to Good Clinical Practice (GCP) standards. In summary, CROs play a role of a bridge between the sponsor, regulators, ethics committee, vendors, hospitals, researchers, and other stakeholders. There are some feathers to sponsor to work with CRO in a clinical trial: saving the budget, project management to the CT, minimum interactions with the regulator, no need to hire an additional staff.
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
As a contract research company, X7 Research’s primary responsibility is to help our clients to bring medicines and devices to the market efficiently and safely, at short notice and with significant reductions in research budgets. We are reliable partner in clinical trials since 2010. X7 Research can help in a strategy development of interventional studies, a preparation of literature reviews, a preparation of post-marketing and non-interventional study concepts. Our medical writing experts (medical writers) have extensive experience in developing clinical trial documents. We will help in the selection of the study endpoints, justification of the required sample size, and the options 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 your clinical trials.
Time Savings
Working with a CRO to conduct a trial often significantly reduces 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.
CROs have already had all necessary tools and resources as well as a team of experts who are experienced in all areas of clinical trials, development, and compliance.
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.
You don’t need to hire personnel, especially when they are not needed during the year.
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.
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
Regulatory authorities require complex and accurate data to be approved and allowed to conduct clinical trials. CROs work within a clinical compliance 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.
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
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?
What is a contract research organization 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 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 for one or more drugs or medical devices. The sponsor can draw on the experience of the CRO. Through the CRO’s repeated trial after trial, which can anticipate possible delays and gaps in the trial and avoid them in advance.
How X7 RESEARCH company works
1
Conducting a gap analysis
2
Literature review
3
Document review
4
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.
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 types of projects they’ve completed, the clients they’ve worked with, any niche services.
Sponsor’s Responsibility
Organizations often outsource any or all of their clinical trial 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 remains with the sponsoring organization. That is why CRO should provide quality work in accordance with government requirements of GCP and other.
The quality and integrity of the clinical research data continue to reside with the entity sponsoring the work. CROs should be backed by a spotless track record of quality assurance and quality control.
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. Any services or components that are not specified in the agreement will remain the responsibility of the hiring entity.
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.
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.
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