Case Studies

Case Study #2


Case Study #2

Study design: Phase IV, therapeutic exploratory, Multi-center, International (EU)

Main study goals: Drug Efficacy and Safety for Cognitive Function Improvement

Project Challenges

  • Data import structure: Study data collected during the trial included data that was obtained from medical devices of several types. Medical devices were one-of-a-kind and any other provider could not satisfy the study goals. Initially, data would be exported and sent to DM 365 for further import into EDC System. However, after the project go-live, it turned out that infrastructure provided by the medical device supplier did not meet Client requirements. Medical device data was crucial to assess primary Study endpoints, however, the data was not backed up with due frequency as to comply with the Client’s internal quality procedures;
  • External data sources: Data came from various sources and in different file formats so further data import mechanism had to be adjusted for a wide range of requirements;
  • Data integrity: Data obtained from medical devices was received by sites. Site staff was responsible for further manual data transfer to EDC System;
  • Data submission: The initial data submission requirements were changed. A year after the project start the Client made a decision to submit study data to the FDA and not to the local regulatory authorities;
  • Data collection: Data collection instruments were designed by the Client. DM 365 standard algorithms of mapping eCRF into SDTM datasets had to be adjusted accordingly;
  • Data collection: The laboratory units were collected in a free-text format bringing DM 365 to a challenge of data standardization.

DM 365 Solution

  • DM 365 data standardization algorithm ensured fast implementation of standardization quotients;
  • DM 365 SDTM diverse functionality ensured instant external data mapping into SDTM dataset;
  • DM 365 came up with a new solution based on existing EDC functionality; Investigators were able to import the data obtained from the medical device directly into EDC. EDC System would then automatically check and reconcile imported data with eCRF data. EDC System alerted the investigator in case any data discrepancies were detected;
  • Profound experience with different regulatory submission requirements ensured submission datasets quality;
  • Communication plan and project planning using Agile principles were implemented;
  • Agile philosophy was at the right time and right place during the process of SDTM datasets configuration.

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