Case Studies

Case Study #1

Oncology

Case Study #1

Study design: Feasibility assessment for a retrospective case study (non-interventional)

Main study goals: Feasibility assessment of retrospective clinical data availability and the possibility of conducting a full-scale rare disease clinical study in Europe and North America.

Project Challenges

  • Non-standard eCRF use, lack of templates, diverse regulatory requirements in different countries (for example, in relation to the personal data collection, Informed Consent, etc.);
  • Since the data was retrospective, identifying and distinguishing the subjects was initially considered as an additional substantial challenge;
  • The fast-paced project with extremely tight deadlines and the large-scale time difference between sites, Sponsor and CRO teams.

DM 365 Solution

  • DM 365 proposed an elegant solution: flexible and convenient EDC & IWRS system MainEDC. Systems functionality allowed to use dynamic controls and groups of controls, thereby avoiding programming a large number of validation checks. Positively, this helped to significantly reduce the budget of the project.
  • When it came to adjustable roles configuration, the system's flexibility was adjuvant. Real-time monitoring allowed to track how much data was already collected and verified, and how much data was still missing thus providing the full and clear picture of the project status at every moment of the study.
  • Thanks to the special subject area provided by MainEDC by default, the challenge of identifying the subjects and distinguishing them was easily tackled. In MainEDC this information is represented clearly and distinctly - subject area appears in the system when an investigator fills in the demographic data in eCRF, it opens by just clicking on the subject number.
  • Considering extremely tight timeframes, DM 365 Team developed detailed text and video guidelines for investigators to save time and facilitate the process of eCRF completion. With clear and transparent instructions, no uncertainties or questions came from investigators while the eCRFs were being filled out.
  • Profound experience in multinational studies helped DM 365 Team to build effective communication and successfully manage the workflow in the context of wide-spaced time-zones and challenging deadlines.

DM 365 team has been superb in support
Flexibility in build and ease of use stated the Client.

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