Neox Clinical Research
Neox Clinical Research is a privately owned full-service clinical CRO with headquarters in Prague, Czech Republic.Conduct clinical trials for pharmaceutical, biotechnology and medical device companies and other CRO’s throughout Europe with focus on Central and Eastern Europe (CEE). The company was established in 2004 and since then have conducted hundreds of studies covering all major therapeutic areas with an emphasis on Oncology, Cardiovascular and CNS.Experienced staff provides high quality, personal service, creating a dedicated team for projects.
Having more than 200 clinical research professionals in CEE countries and another 110 employees in partnering CRO’s makes Neox one of the largest Central and Eastern European CRO’s. Neox operates in Austria, Bulgaria, the Czech Republic, Finland, Germany, Hungary, Poland, Romania, Slovakia, Sweden, Switzerland and the United Kingdom. In other European countries operate through partners. [1] Neox offers 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 & audits, regulatory and ethics committee submissions, site contracting, study rescue and training & education, for Phase I-IV studies. We offer our services as a full-service package or individually as a tailored solution to your specific needs. [2]
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| Type | Private |
| Headquarters | Prague, Czech Republic |
Service
- Biostatistics
- Clinical monitoring
- Data management
- Outsourcing
- eCRF design
- eDiaries
- Drug safety
- Medical monitoring
- Medical writing
- Pharmacovigilance & devicevigilance
- Project management
- Quality assurance
- Regulatory and ethics committee submissions, IRB
- Sitecontracting
- Training and education
DRUG SAFETY AND PHARMACOVIGILANCE Effective processing of clinical trial safety data is imperative to the successful performance of a clinical trial and to guarantee post-marketing safety. NEOX offers effective management of clinical trial and post-marketing adverse events from case assessment to expedition. NEOX take care of all requirements for case processing, expedited reporting, periodic safety update reports (PSURs), literature screening and safety signal detection and review. If needed NEOX provide and run entire pharmacovigilance operation. Listed below are areas of pharmacovigilance where NEOX provides high-quality services:
- Clinical Trial Safety
- Pharmacovigilance Agreements
- Pharmacovigilance System Master File (PSMF)
- National Person Responsible for Pharmacovigilance (NPRP) in CZ, SK, PL, AT, SL, BG, RO
- Pharmacovigilance Audit
- Pharmacovigilance Training
- Literature monitoring in Local language
- Risk Minimisation activities/Risk management plans
- Post-Authorisation Safety/Efficacy studies (PASS/PAES) Development
CLINICAL TRIALS PHASE Ι – ΙV NEOX has been an actively participating in the business of clinical studies since 2004. Over the time, NEOX’s scope of activity has expanded, not only in terms of regional coverage but also in terms of the type of study and services rendered. [4]
Reference
- ↑ https://www.linkedin.com/company/neox
- ↑ https://www.neoxcro.com/company-profile/about-us/
- ↑ https://www.neoxcro.com/what-we-do/drug-safety-pharmacovigilance/
- ↑ https://www.neoxcro.com/what-we-do/clinical-trials/
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