Services
Services in Clinical Research:
-Project Management
-Clinical Team Management
-Human Resource Management (flexible outsourcing of CRAs/CTAs)
-Clinical Site Monitoring
-Start-up and Regulatory Services
-Site Coordination
-Project in/outsourcing
-Contracted QA audits
-Translation services
N&Sz StudyMaster CRAs and other team members are able to conduct all aspects of clinical monitoring according to the required SOP's and current regulatory and ICH-GCP standards. Therapeutic experience of our team covers all current indications of clinical research projects. Experience of staff includes but not limited to the following activities on the clinical field:
-Feasibility studies
-Start-up and Regulatory procedures
-Pre-study Site Evaluation and Investigator Assessments (Site Selection)
-Site Initiation
-Site Trainings
-Site Monitoring in Phase II-IV Clinical Research Trials (Interim Monitoring)
-IMP Management (Blinded & Unblinded)
-Site Close-out
-Filing & Archiving
-Quality Assurance, Contracted Audits
-Translation and translation verification services
Local and regional operations
The current operational activity focuses to Hungary. Some projects extend beyond the borders of the country mainly in the Central and Eastern European region, in Serbia, Czech Republic, Poland; others include all EU, including Western European countries. Our international experience with all Europe and North America gives the opportunity to provide broader project coverage (e.g. all Europe) if needed.
Quality in Clinical Research
Our CRAs have mostly medical and pharmaceutical degrees and regularly take part in ICH/GCP trainings sponsored by us as well as internal trainings (see also below). It is required to have at least two years of field monitoring experience for the sCRA to be employed. In exceptional cases 1-2 years of CRA experience might be sufficient if other capabilities are above average, but some experience on the clinical field is a must. During the staffing process, thorough evaluation is made by our Senior Management for both clinical/scientific & GCP knowledge and the human factors (motivation, emotional and personal stability, etc.) in order to ensure the successful partnership both with the Employee and our Partners.
Quality controlled continued evaluation process is applied to supplement individual monitor training, in order to maintain the highest quality standards. Own SOPs have been developed for internally managed projects, outsourced colleagues work according to the SOP of our Clients, as requested. Regular internal trainings and SOP updates ensure maintained high quality. Internal trainings always involve latest information on regulatory guidelines and ICH-GCP and certificates of attendance are provided for our colleagues’ training records.
Human resource management, insourcing according to the latest legal environment. The N&Sz Studymaster has partnership with different pharmaceuticals and CROs. We increase the number of experienced colleagues at certain companies/projects.
The human research management at N&Sz Studymaster means not only insourcing but also managing the insourced colleagues if needed.
Site management
Wide range of our relation with the clinical sites helps us to select the most appropriate site for the certain project. The good personal relationship assists us to finalize the contracts at the earliest convenience.
Medical writing
Complete the medical writing from the collected data. In case of claim to publishing the medical writing, N&Sz Studymaster organize the publication at reputed Hungarian and foreign papers.
The Manage it well program published in the Journal of Hypertension( Journal of Hypertension 2005, 23: 203-211), and in a WHL Newsletter ( WHL Newsletter No. 106, April 2006) are good examples.
Trainings: monitor trainings, medical/marketing and communications trainings
Market research: – designing and accomplishing qualitative, special and extensive researches