Data entry

MediCase has an easy to use interface to enter and find data. Access to enter/view/edit can be granularly controlled through a range of user roles. MediCase assists the user in the data collection, and the result is quicker data collection with higher quality.

  • Warnings & errors on data entry
  • Handling of missing values and comments
  • Searchable dictionaries, e.g. ICD-10 and ATC
  • Automatic calculations
  • Multilingual forms

Quality control

MediCase offers a wide range of features to help raise the quality of your data, and to manage the quality control process. Risk-based (and other selective) monitoring plans can be integrated to get the very most out of limited monitoring resources.

  • Hard and soft range checks (value limits)
  • Logical data validation checks
  • Data queries (by monitor, data manager, or investigator)
  • Source Data Verification (SDV)
  • Customizable monitoring plans
  • Electronic Notes to File

Study/registry management

Planning, managing and overseeing the study and data collection is as important as it may be daunting without the proper tools. MediCase enables you to get your data collected and available where and when needed, with less management and administration.

  • Visit planning
  • Demo mode for staff training and try-outs (available at any time)
  • Graphic overview of visit and form progress
  • Controlled dataset access *
  • Data export as text files, Excel documents and archive PDF documents
  • Unlimited free data downloads 24/7 *
  • Rejection log
  • Real-time recruitment statistics

* Access permission controlled by user roles, varies by configuration and database lock status. Typical configuration gives only the Data Manager and Data Safety Monitoring (if applicable) access to datasets before the database is locked

Randomization

Let MediCase handle the randomization in your (randomized) study. It will reduce the risk of mistakenly randomizing subjects who don’t meet eligibility criteria, and you will be free of physical randomization envelopes that sometimes are impractical to store and access safely.

  • Integrated randomization
  • Stratification
  • Variable block sizes
  • Configurable for random sub-population sampling

ePRO

MediCase features an integrated ePRO/PROM module, which safely lets subjects answer questionnaires, at the clinic or from home, without any risk of accessing other functionality or data.

  • Multilingual patient questionnaires/surveys
  • Easy switch to subject entry mode
  • Subject login from home
  • Support for mobile devices

General/other

  • Audit trail
  • Electronic signing for investigators
  • Automatic backups
  • Automatic scoring
  • Supports protocols where study procedures may differ by treatment arm (e.g. open label randomized device studies)
  • Medical coding (at data entry or by dedicated medical coders)