Our contract research organization can help in:
- research and consultation in the process of a drug development for further clinical trial different clinical studies
- conducting clinical trials of different clinical studies, including both early and late clinical studies
- registration, introduction of changes in the registration dossier to regulatory authorities
- post-marketing study of a drug
- clinical trial study design
- 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
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 studies I-III clinical trials to registration, post-registration study (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 for different studies. Audits both internal and external prove its’ effectiveness.
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 in clinical trials?
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.
Registration strategy & consulting
– Data search and analysis for any study
– Registration strategy development of drugs and medical devices
– Study feasibility
– Vendor selection depending on the project
– Clinical trials budgeting for any study
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 study 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 for any clinical study.
– Building a system of pharmacovigilance
– Safety in different studies clinical trials
– A pharmacovigilance audit
– A pharmacovigilance contact person
X7 Research company offers a wide range of services in all studies 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.
– Development of medical documentation and biostatistics
– Data management
– Patient home visit
– Bioequivalence study
– Therapeutic equivalence study
– Study design clinical trials
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.
– Audit of a registration dossier
– Bringing a registration dossier in compliance with requirements
– Conversion of a 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 clinical studies of the registration of a medicinal product. Employees of X7 Research can conduct a 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 isto conduct research activities, explore the potential of young professionals and provide quality services to partners and clients of clinical trials different clinical studies, 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 any study. 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 for any study of clinical trial.
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
Primary responsibility of X7 Research as a contract research company 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 for any study. 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 at any study. 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 for any study.
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 clinical studies.
Trials Cost Savings
By hiring a CRO, you can save a lot on your clinical research budget for any study.
By itself, a faster litigation offers healthcare providers cost savings, such as hiring staff for a project or permanent job.
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 studies 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 any study. 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.
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 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
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.
Comparing one CRO to another can be very difficult, as CRO budgets and services often vary significantly from one company to another to any study. 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 and studies that they made, including 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 at any study of clinical trial.
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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, biological assay development, commercialization, preclinical research, clinical research, contract research, clinical trials management, and pharmacovigilance for any study
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 studies 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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