Empower your NIS study with the right software solution
NIS (non-interventional) studies have proven to be of high importance to clinical research, bringing essential scientific value for industry breakthroughs. This means they require corresponding quality control measures.
NIS studies are epidemiological or observation studies, in which no study-related intervention is performed on the patient. The data obtained is derived from routine treatment of patients rather than from additional diagnostics. The concept of NIS studies has acquired another perspective in light of the escalating interest toward “real world data” and “real world evidence” within clinical trials.
The standards and guidelines for non-interventional studies are not as rigid as for other types of
studies. Such studies do not require authorization from the Federal Service for Surveillance in Healthcare (Roszdravnadzor) in Russia and other EAEU countries. As a non-interventional study progresses, the quality of data becomes increasingly significant. The aim of data management services and solutions providers is to make valid, scientific statements based on the results, striving to avoid possible bias of results by using thorough data analysis, to assure authenticity, completeness and validity of the data and to identify and resolve deficiencies during the early stages of a study. There is no doubt that the laws, guidelines, and recommendations regulating NIS are very helpful in implementing quality assurance measures, but without a highly competent and dedicated NIS team the success of the project can be jeopardized.
Benefits of EDC for NIS studies
Here is what you get when opting for the right solution for collecting and processing data within NIS studies:
- Valid data even without 100% SDV
- Short study timeline — eClinical solutions allow the shortening of the timeline for double data entering, and as a result, cut back on labor costs. Unlike a paper-based approach, having a modern EDC system to bring data together will be key to instant access to CRFs for all participants and the acceleration of all processes.
- Cost reduction: logistics (sending of CRFs to sites and back) and CRF printing (in the case of a paper-based approach. CRFs must be printed in triplicate in accordance with all standards on special self-copying paper). Using EDC makes it possible to reduce all these costs.
- No need to archive the paper CRFs for 1000 patients (electronic format).
- Quick mid-study changes — deployed within one CRF update, saving both time and money.
- Effective staff work the electronic solutions — due to the proper training provided by vendors even the regular doctors are able to operate EDC.
Using data management eClinical solutions enable pharma companies to build and manage their studies with ease and efficiency, to program edit checks effortlessly, and to deliver valid data without 100% SDV. Russia-based vendor Data MATRIX brings its passion for keeping within study timelines and budget without compromising quality, enabling it to increase efficiency in NIS studies, minimize the risks to study success and patient safety, and deliver high quality data faster. Data MATRIX’s services are delivered by an experienced and talented team of professionals ready to fit our services and solutions to your specific trial needs.