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Neox

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Neox

Neox is a privately-owned full-service clinical CRO with headquarters in Prague, Czech Republic.

We conduct clinical trials for pharmaceutical, biotechnology and medical device companies and other CROs throughout Europe, with a focus on Central and Eastern Europe (CEE). With more than 230 clinical research professionals in CEE countries, and 80 employees in partnering CROs, Neox is one of the largest Central and Eastern European CROs.

neox clinical trials

What we do – Excellence in clinical research

Neox is a full-service CRO offering clinical research services such as: biostatistics, clinical monitoring, data management, eCRF design, eDiaries, expert consultancy, drug safety, medical monitoring, medical writing, pharmacovigilance and safety, project management, quality assurance and audits, regulatory and ethics committee submissions, site contracting, study rescue, and training and education for Phase I-IV studies. We offer our services as a full-service package or individually as a tailored solution to meet your specific needs.

Quality assurance and control

We are committed to maintaining the highest quality of work to our clients. Our standardised QA processes mean that we can promise sponsors that each research project is conducted ethically, in compliance with the protocol, relevant SOPs and ICH GCP. Clients can also be secure in the knowle and that the data collected is accurate and verifiable.

To provide continuous quality control, assurance and improvement, the main tools we use are:

  • Internal audits
  • On-site co-monitoring visits
  • Metrics/key performance indicators
  • Review of CRA monitoring visit reports and follow-up letters
  • Annual performance reviews
  • Review of the personal and training file for all Neox employees

Phase I-IV studies

Neox is your trusted partner for the entire clinical development process, offering strategic and therapeutic leadership, throughout the duration of your project.

Extensive Phase I-IV experience

We have Phase I-IV experience in a variety of therapeutic areas in almost all European countries.

Regulatory leadership

Our regulatory managers work to guarantee that every aspect of the trial is correctly designed for regulatory approval.

From Phase I, all the way through to Phase IV, you can be feel safe in the knowledge that your study is performed under high-quality standards. Our therapeutic experts, project managers, and CRAs certify that your study will be running without delays in a cost-efficient way.

Neox is here to provide services at any stage of drug development in any European country. We aim to exceed your expectations.

phase studies

Training

High performance quality starts with clear standard procedures, detailing training processes for both onboarding and continuous training.

Specific role-based curricula are in place for all key job roles.

The training process includes:

  • ICH GCP and clinical trials training
  • Practical on-site training for CRAs
  • Neox SOPs training
  • Sponsor processes training
  • Therapeutic area and other project-specific trainings
  • Periodic advanced trainings
  • Periodic on-site co-monitoring for CRAs

The new-hire onboarding programme is led by a Neox trainer and internal speakers.

The theoretical part of the training is followed by a practical on-site monitoring training specific for CRAs.

Training on relevant Neox SOPs is completed by each Neox employee. Training on sponsor SOPs, systems and project-specific trainings are provided according to sponsor instructions.

Therapeutic area and investigational product trainings are typically provided by the Neox medical director, if agreed by the sponsor. For periodical advanced training, both internal and external speakers may be invited.

Quality of service is also supervised through periodical on-site co-monitoring visits and internal audits.

Where we are – We go where the patients are

Years of clinical research experience, understanding local requirements and established relationships with investigators, ensures that your trial will always be performed in an optimal setting for high patient enrolment.

Neox operates in Austria, Bulgaria, the Czech Republic, Finland, Germany, Hungary, Poland, Romania, Slovakia, Sweden, Switzerland and the United Kingdom. In other European countries we operate through our partners.

Clinical trials in the Central and Eastern Europe region

The total population of the Central and Eastern European region exceeds 300million, providing access to a large pool of potential clinical trial subjects. The healthcare systems in the CEE region are highly centralised, as most patients are referred to major centres where they always visit the same doctor. This results in a strong personal relationship between patients and their doctors. These factors have an additional positive impact on data quality through better patient compliance, faster and easier patient enrolment and lower dropout rates even in long-term trials.

With Neox you will experience rapid enrolment and you will have access to leading, highly motivated investigators. Although investigator fees in Central and Eastern European region are increasing and falling into line with those of Western Europe, the overall costs in the CEE region still remain lower due to faster patient recruitment, a larger number of enrolled patients, and high quality of data resulting in lower data query rates.

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Please see our contact details below for further information.

Contact details:
Neox s.r.o, Corporate Headquarters

V Jámě 1
Praha 1, 110 00
Czech Republic
Phone: +420 241 400 761
Email: info@neoxcro.com
Website: www.neoxcro.com

Biostatistics and Data Monitoring

We provide data and biostatistics monitoring to meet the varied clinical needs of our customers.

Data managementNeox offers data management to customers conducting experimental research in the various fields of life sciences.Our data management is based on an electronic data capture (EDC) system. The EDC offers you paperless data collection with online query resolutions. Since there is no need for hardware or software installation, we can work according to your…

Clinical and Medical Monitoring

Our clinical and medical monitoring services are run by the most qualified professionals, with competences in clinical trial processes, medical management and much, much more.

Clinical monitoring servicesNeox clinical monitoring services are conducted by qualified professionals with vast know-how in clinical trial processes and ICH-GCP guidelines. Our clinical research associates (CRAs) plan, execute and support clinical site management activities, ensuring safety of participants is not compromised and that the data on our clients' study are of the highest quality and…

Project Management

Our project management services are conducted by qualified professionals with vast know-how in clinical trial management. This includes regulations and guidelines, clinical trial processes, ICH-GCP guidelines, relevant therapeutic indications, as well as time, cost and quality metrics.

Managers at NeoxOur managers have strong interpersonal and communication skills, and are enthusiastic about leading and managing people. What's more, Neox managers display outstanding planning and mentoring skills, and can work successfully in a matrix environment.Neox has two types of project managers: Project Managers (PMs) and Line Managers (LMs).Key responsibilities of PMsEnsure the overall study…

Regulatory Affairs

NEOX's regulatory affairs section is based on the knowledge of local experts with experience and understanding in regulatory processes, national guidelines and procedures with different types of registration, such as national, centralised, decentralised or mutual recognition procedure.

We also provide an all-inclusive assessment of the dossier, as well as any relevant documentation to ensure a smooth registration process. On top of this, we can also offer scientific advice of any issues relating to the registration documentation.Key responsibilitiesThe key responsibilities of our regulatory affairs managers include:Coordinating and preparing documents for registration submissionsManaging all…

Site Contracting

Neox has all the necessary experience and resources to draft, execute and enforce a top quality contractual document relating to clinical trials.

In-house and external specialised lawyersWe have both, in-house and external specialised lawyers, at hand to assist you with your contracts. The responsibilities of our lawyers include:Drafting, evaluating, commenting and/or amending clinical trial agreements with sites, investigators, pharmacies, health institutions and other persons involved in clinical trialsMaking sure the contractual documentation is compliant with the legal…
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