Online Anwendungsbeobachtung und Studien - eAWB - elektronische Anwendungsbeobachtung

MedITEX Online NIS

Online Non-Interventional Studies (NIS) for pharmaceutical manufacturers

The internet is the ideal solution for the efficient implementation of NIS (non-interventional studies) as well as for general clinical surveys and reviews of medical products. The paper as medium in comparison looks old and outdated.

  • Best data quality: Automatic plausibility check: Only in case of doubt will the doctor be asked to verify her/his entries.
  • Fast and timely feedback: Digital data can quickly be processed, analysed and published.
  • High involvement: Survey participants can access the monitoring plans, individual statistics and graphical representations of survey progression.
  • High security: MedITEX password protection and encrypted transmission ensure maximum data security.
  • Time saving: Faster, daily actual feedback gives you the opportunity to timely react on developmental changes.

Design & development

Already before the launch of an online study many different aspects need to be thoroughly considered. Especially in the view of the subsequent analysis and reporting of results is a detailed design crucial for success.

In web-based applications we rely on intelligent forms in order to obtain reliable information. In this way we achieve valid and plausible results. Using so-called hard-checks the factually incorrect data is excluded already during the input filter. The selective use of plausibility checks ensures that unforeseen entries will automatically be questioned. Without the full coverage of all required fields a completion of a survey is not possible.

In the online centre specifically designed for your surveys a doctor logs in and is able to enter, view and proof patient and survey data. The user interface is designed after software ergonomic principles. Thanks to the clean design the use of online survey portal is intuitive and easy.

Hosting

Through our secure IT centre we offer high availability of your data so that survey information can be accessible at any time. We rely on our own development but also on widespread professional software: as a technical platform we use LAMP servers with Apache as a Web server and PHP / ExtJS as middleware services. This infrastructure has proofed itself very reliable in the past due to its stability and flexibility, and is continuously further developed.

  • All study data is automatically backed up at hourly basis. Copies of the data can be generated any time in electronic, easily readable form. The control of the study course is thus possible around the clock.
  • Each study becomes is a unique electronic signature assigned. This signature is than attached to every created or edited record.
  • The study data is always collected in the same way. Dissenting documentation is prevented in background, through extensive hardware and software checks.
  • Access to the system we grant only to a narrow, well-trained workforce circle. Access to the data is possible only with a special password.

Evaluation

Our experienced statisticians evaluate the survey's data and generate reports. The results are produced according to your wishes and delivered as a detailed report and an appealing presentation.

Apart from the final analysis, we also offer interim reports. At regular intervals we can provide you overview of the course of the study.

Additionally we can produce any kind of further statistic evaluations if desired.

Rewarding

  • Contract management
  • Data validation
  • Verification of the regular fees

In the online survey centre doctors can always view their pending payments.

Using our largely automated payment system, we can transfer - e.g. quarterly - the remunerations to the correct bank accounts.


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