Our contract research organization can help your company:
- research and consulting in the process of clinical trials
- providing clinical trials for your medical devices and drugs
- registration of drug and medical devices according to regulators
- we offer a wide range of services in the post-marketing phase of the drug lifecycle
- well qualified organization of the pharmacovigilance system
- home care service for patients
X7 Research conducts research activities, exploring the potential of young professionals and expanding the development prospects of both employees and the pharma industry.
Why clients choose our CRO in pharma
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 clients are local companies as well as Big Pharma. Our clients stay with us and conduct several clinical trials in a row.
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 in pharma?
What Does A CROs Do In Pharma industry?
Contract Research Organizations (CROs) are companies that conduct clinical trials and provide research support services in the fields of biotechnology, medical devices and the pharma industry, focusing on conducting research within the established budget, respecting research deadlines
OUR SERVICES IN X7 RESEARCH
Registration strategy & consulting
– Research and analysis data
– Development of a strategy for the registration of drugs and medical devices in the pharma
– Study feasibility of clinical trials
– Choosing a vendor according to your research
– Budgeting in advance of any clinical trial for better study design
X7 Research has extensive experience in searching and analyzing information on specific medicines in various therapeutic areas in order to prepare a strategy for registering medicines under the laws of Russia, the EAEU, the CIS, the EU. Our scientific department of X7 Research performs qualitative and quantitative evaluation of sources to prepare a completed documents in any therapeutic area.
Post-authorization clinical studies
– Phase IV studies
– Non-interventional studies
– Post-authorization safety
X7 Research offers a full range of services for the post-marketing stage of the drug life cycle. Our company is ready to conduct both large-scale studies to obtain large volumes of real data (RWD) and small-scale exploratory studies. The X7 Research team is ready for any challenge and the most ambitious projects. We are always trying to find individual decisions to each project.
– Building a system of pharmacovigilance
– Safety in clinical trials
– Pharmacovigilance audit
– Pharmacovigilance contact person
– QPPV in FV system
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
– Development of medical documentation and biostatistics
– Monitoring your clinical research
– Data management
– Patient home visit
– Bioequivalence study
– Therapeutic equivalence studies
Our CRAs are verifying that subjects’ rights and welfare are protected, the data submitted is accurate, complete, and supported by primary documentation and the study is conducted by the approved current version of the protocol/amendments, GCP, and regulatory requirements.
– 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 in the territory of the Russian Federation and the Eurasian Economic Union countries.
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Our goal is to continually research, improve and conduct quality clinical research in accordance with your therapeutic area, the length of your clinical trial and your budget. X7 Research is a reliable partner for the trials in challenging regulatory environment and tough economy.
Contract Research Organization Roles and Responsibilities in pharma
A CRO is responsible for the planning, setup, and day-to-day execution and management of a clinical trial. An important task of the CRO is also supervision and monitoring, check the correctness of filling out reporting documents and the technical aspects of the study.
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.
OUR PURPOSE IN PHARMA
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. We are highly experienced in conducting clinical trials, providing market analysis, consulting in the field of market access.
BENEFITS OF OUTSOURCING TO A CRO X7 RESEARCH
Outsourcing to a Contract Research Organization can bring multiple benefits to pharma companies.
Working with a CRO to conduct a clinical trial often significantly reduces the time required compared to completing a trial in-house, as the CRO has expertise in record keeping, routine testing, and a faster process for writing key documents: investigator brochure, trial protocol, and others.
CROs have already had all the necessary tools and resources, as well as a team of qualified experts with experience in all therapeutic areas of clinical trials, development, and compliance.
Trials Cost Savings
When a sponsor uses the services of a CRO, significant savings can be made on the outsourcing of pharmacy personnel. By itself, a faster litigation offers healthcare providers cost savings.
X7 Research offers staff outsourcing for your specific clinical trial, allowing you to reduce staffing costs in the pharma industry.
Working with CRO provides hiring companies with access to the most advanced technologies and systems for data management, product development, research analysis and other clinical research services in any field of pharmacy.
Clinical research is a rapidly changing industry that requires advanced IT solutions, computer-assisted data management, and validated record keeping technologies.
Evolving and Complex Regulatory Requirements
Regulatory authorities require complex and precision information from sponsors to validate and control the quality of pharmaceutical 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.
CROs work with hiring organisations 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 according with your drug or medical device
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 in pharma?
The CRO is a contract research organization that plans, develops and coordinates the validity of the processes for conducting a clinical trial according to a trial protocol. It then performs this protocol in accordance with the rules of the regulatory body and GCP standards. Also, an integral part of the work of the СRO is the work with the principal investigators of the centers and with patients.
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
Working with a CRO in pharma
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 choosing a CRO, look at 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. Also, an important part of the work of a contract research organization is work in various therapeutic areas: cardiology, oncology, ophthalmology, neurology and many other areas.
A business, organization, or institution may outsource any or all of its clinical trial and research responsibilities to a Contract Research Organization, but the responsibility remains with the original company that hired the CRO. Therefor, the sponsor is responsible for the safety of the investigational product in clinical trials.
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 to be competitive with other organizations
Get It In Writing
Clinical research is very expensive, it should be clear which organization are responsible for each aspect of medical research, development, or other clinical services. Responsibility for any services or components not specified in the agreement remains with the sponsor, that is, the organization employing the CRO.
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.
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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