{"id":50,"date":"2022-02-21T17:42:04","date_gmt":"2022-02-21T16:42:04","guid":{"rendered":"http:\/\/raffeiner.atomproductions.at\/services\/"},"modified":"2023-06-22T15:38:05","modified_gmt":"2023-06-22T13:38:05","slug":"services","status":"publish","type":"page","link":"https:\/\/www.studien-monitor.at\/en\/services\/","title":{"rendered":"Services"},"content":{"rendered":"\n <\/div>\n<\/div>\n
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Non-interventional study – NIS<\/h3>\n

The term ‘observational study’ (also ‘in-use study’) was mentioned for the very first time in the Austrian Medicinal Products Acts (Arzneimittelgesetz; AMG) in the year of 1994. Its primary purpose was to differentiate this type of study from a clinical trial. However, in view of the terminology commonly used in Europe, an amendment to the […]<\/p>

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eCRF, clinical data management & statistics<\/h3>\n

Data capture using paper case report forms has become increasingly rare in clinical trials. Instead, there is a trend towards direct data entry in electronic form. With the validated and certified eCRF-system TrialMate our company provides a completely web-based software solution for easy and intuitive capture of patient data. Since the year 2011, TrialMate has […]<\/p>

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Consulting and lectures<\/h3>\n

Thanks to the extensive experience in clinical research of our CEO Mag. Andreas Raffeiner, our company offers consulting and guest speaking activities on request, in the areas of GCP, monitoring and project management in clinical research. The main clients in this area are independent service providers in the pharmaceutical industry, pharmaceutical companies and medical devices […]<\/p>

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Audits<\/h3>\n

In terms of quality assurance the sponsor is often interested in audits performed by an external expert to verify that all study-related activities and documents are carried out according to protocol, sponsor SOPs, GCP and legal regulations. Our company offers the planning, conduction and documentation of audits at one or several study centers, at the […]<\/p>

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Recruitment services<\/h3>\n

Patient recruitment is the most time-consuming aspect in a clinical trial and is considered to be the biggest obstacle for its success. Investigators often overestimate their pool of potential patients and are not capable to reach the enrollment demanded by the sponsor. Slow or insufficient recruitment therefore affects the clinical trial\u2019s timelines, budget and time-to-market-authorization […]<\/p>

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Project management including submissions<\/h3>\n

To verify efficiency and safety of new therapies it is necessary to test them systematically under controlled conditions.  Beyond proven therapy success, it is also essential that the clinical trial is compliant with given quality standards and legal regulations in order to obtain market authorization. This is exactly the target our enterprise is aiming at: […]<\/p>

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