eCRF

Clindex® enables you to provide your study sites the ability to enter and manage their own eCRFs, run reports and exchange study documents; when, where and how you want. Improve efficiencies and data quality. Reduce data processing and study administration time and for your clinical staff, maintain process and data integrity and simultaneously create efficiencies for your site users. By using state of the art technology, there is no need for your sites to install or worry about having the right version of the clinical software. With Clindex®, you are able to conduct your study as EDC, paper-based or a hybrid of methodologies. You don’t have to be locked into one data collection method or have your data collection method lock you out of sites – you can choose the best methodology for each site, right down to the eCRF page, all within one unified solution.

  • Fully customizable data entry screens
  • Data entry screens can be generated directly from Word documents
  • eCRFs can be directly linked to bitmaps and documents. Documents can be displayed directly on the data entry screen (e.g., MRI scan images)
  • Repeated or nested tabular eCRF sections can be displayed on the same screen as non-nested data. i.e. Data entry screens can exactly match paper eCRFs.
  • Conditionally prefill tabular eCRF data based on data entered into eCRF
  • Standard role based security plus advanced security mode which includes conditional hiding of questions, images, pages and control of new eCRF input, update or viewing of existing eCRFs.
  • Allow creation of patient-related eCRFs or alternate forms for other purposes (e.g. CTMS) using the same tool set.
  • Electronic CRF data can be uploaded and attached to an entered eCRF
  • Ability to create Subject binder with eCRFs, modifications, queries, e-signatures in a single PDF (including table of contents)
  • Real time field range validations and complex cross-CRF computed fields and validations
  • Real time queries and queries that fire only on data completion
  • Allows both sponsor and site eCRF locking
  • Visit manager tracks which eCRFs are due and existing eCRF status
  • Task list tells sites which eCRFs need to be collected, entered and signed
  • Support for automatic activities upon eCRF save such as generation of a bar code label, automatically running a report, etc.
  • Allows 2nd pass data entry (interactive double-key verification or visual review)
  • Randomization assignments available on any eCRF
  • Floating data entry hints
  • Data issue highlighting and generation directly on data entry screens
  • Annotations highlighting and addition directly on data entry screens
  • Manual or automatic creation of data issues (Queries/DCFs, etc.)
  • Supports advanced edit logic
  • Uses intuitive web style interface for Remote Data Entry (RDE)
  • Control which users can access, sign and modify CRFs
  • On-screen highlighting of data queries/annotations/modifications
  • System auto-detects multiple users with same eCRF open and supports first save or first open priority.