StudyARCHIVE program package for the implementation of study projects with defined time intervals (e.g. application observations)

StudyARCHIVE: Program package for carrying out study projects with defined time intervals - study environment from eCRF, biobanking, data warehouse, analysis and reporting.

Your advantages

  • Project planning and cost planning: Together with you we record the goal of your project, define the key parameters and plan the most important milestones for a successful implementation.
  • Consulting and creation of eCRF’s: To document your data, we use our in-house EDC system, hosted on professional server solutions including functions for reporting, statistics, query management.
  • Processing of paper questionnaires  e.g. in the context of health economic surveys
  • Conception and production of all documents
  • Preparation of the ethics vote
  • Settlement of all official matters
  • Support of the participating centers
  • Fee for participants: handling of all financial matters
  • Honorierung der Teilnehmer: handling of all financial matters
  • Quality assurance, data management: Your entered data will be analysed and evaluated. Support of the participants: Our support is available to you and all participants of the project for all questions concerning the study.
  • Message from SUE to the AMS
  • Pseudonymization Service: The Pseudonymization Service (PSD) encrypts sensitive data in multicenter projects in accordance with ISO Standard 25237 and the data protection concept of TMF. Hosting of the Web application Control: audit trail, role concept and encrypted data transfer: Extracts from FDA regulation 21 CFR 11 are taken into account.

  • Optional: Interfaces to production systems. The setup of interfaces enables the direct transfer of data from information systems (e.g. via HL7).
  • Optional: individual import of legacy data

 

 

Read the product description of StudyARCHIVE.

 

 


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