Our contract research organization can help in:
- research and consulting in the process of drug development
- providing clinical trials
- registration, modification of registration dossier etc.
- post-marketing of the drug
- organization of the pharmacovigilance system
- home care service
Our contract research organization provides a systematic approach to solving clinical trials
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. With us you don’t need to hire different companies we can do it all by ourselves.
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 and provide research support services in the field of biotechnology, medical devices, and the pharmaceutical industry, as well as in universities, government organizations and foundations.
Registration strategy & consulting
– Data search and analysis
– Registration strategy development
– Study feasibility
– Vendor selection
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 are 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.
– 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.
– Development of medical documentation and biostatistics
– Data management
– Patient home visit
– Bioequivalence study
– Therapeutic equivalence studies
X7 Research team are always trying to find individual solutions for each clinical trial and each partner.
– 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 company provides services for state registration, modification of 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 countries.
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Our goal is to conduct research activities, explore the potential of young professionals and expand the development prospects of both employees and the pharmaceutical industry.
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 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 company primary responsibility is to help our clients in bringing medicines & devices to the market efficiently and safely. We are reliable partner in clinical trials since 2010.
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 time it takes compared to completing the trial in-house.
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
There are significant cost savings in hiring a CRO. A faster trial process alone offers medical institutions a reduction in costs.
You don’t need to hire personnel, especially when they are not needed during the year.
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
The FDA and other relevant regulatory authorities require intricate and accurate data for approvals. 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 or Good Laboratory Practice (GLP) 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
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?
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.
A sponsor — who might have many potential treatments they wish to have 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 is a wide variety in CROs. Some are large, publicly owned companies with global coverage and a range of comprehensive services, while other CROs are small, privately owned companies that specialize in a specific area.
Comparing one CRO to another can be very difficult, as CRO budgets and services often vary significantly from one company to another. When selecting a CRO, note 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 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 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.
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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