Looking for suitable Contract Research Organization?
Looking for suitable Contract
Research Organization?
send us an email to research@x7cpr.com
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
send us an email to research@x7cpr.com
Do you need more infromation?
send us an email to research@x7cpr.com
Why clients choose our CRO
X7 Research’s company primary responsibility is to help our clients in bringing medicines & devices to the market efficiently and safely.
X7 Research company is ready to conduct clinical trials and provide research support activities
Contact usOur Email: research@x7cpr.com
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.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 study
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.
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, from individual consultations to complete pharmacovigilance.
Clinical trials
— Development of medical documentation and biostatistics
— Monitoring
— 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.
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 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.
START A PROJECT WITH X7 RESEARCH
Our email: research@x7cpr.com
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.
OUR PURPOSE
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.
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
Do you ready to choose X7 Research company as a CRO? Email us to research@x7cpr.com
BENEFITS OF OUTSOURCING TO A CRO
Outsourcing to a Contract Research Organization can bring multiple benefits to clinical professionals and institutions.
Time Savings
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: 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.
At list you don’t need to hire personnel for this job.
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 fastly 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 optimizes 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
Our Email: research@x7cpr.com
This is what our clients say about us:
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.
How X7 RESEARCH company works
1
Conducting a gap analysis
2
Literature review
3
Document review
4
Preparing a drug registration strategy
Our contract research organization provides a systematic approach to solving clinical trials
Do you need more infromation?
send us an email to research@x7cpr.com
Our contract research organization provides a systematic approach to solving clinical trials
send us an email to research@x7cpr.com
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 niche area.
Comparing one CRO to another can be very difficult, as CRO budgets and services often vary significantly from one company to the next. When selecting a CRO, take into account 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.
Sponsor’s Responsibility
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.
X7 Research company 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.
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.
START A PROJECT WITH X7 RESEARCH
send us an email to research@x7cpr.com
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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.
CONTACT US
Contact us:
Our Email:
research@x7cpr.com
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