Dacima Software

Automated site shipment algorithms that can be adjusted throughout the clinical trial

Automatic email notifications sent to distribution centres when site inventory drops below threshold

Automated email notifications for various system events and alerts

Integrated web randomization module supporting simple, block, permuted block, and minimization randomization methods

Complete audit trail tracking all system events for FDA compliance and regulatory requirements

Support for E2B format for pharmacovigilance reporting and adverse event management

Electronic consent forms with digital signature capabilities

Electronic diary features supporting daily or hourly data collection

Capture patient-reported outcome data from any device

Sub-questions appear based on selected image zones with dynamic background color changes based on responses

Allows users to enter data by clicking on predefined zones or regions of uploaded images

Collect data electronically in regions lacking web connectivity with distributed offline database system

Next generation data types including subforms, dynamic grids, static tables, panels, modal popups, and image-based data entry

Advanced validation rules and edit checks for data quality assurance

Many built-in functions available for setting up advanced validation controls

Validation checks across items on different forms for data consistency

Validation for missing values and value ranges at field level

Configure simple or complex validation rules through easy-to-use web interface with no programming needed

Partial date data type with option to impute missing date parts

Flexible web-based user interface that can be customized for different study types

Powerful designer module that allows creation of electronic Case Report Forms and questionnaires without programming expertise

Create professional databases through easy-to-use graphical web interface with no coding needed

Single or multi-stage eligibility forms with automated validation checks

Create single or multiple inclusion forms completed sequentially with status tracking throughout enrollment process

Ability to upload and download files within the system

Advanced study management allowing monitors to review data, add data queries, and electronically sign off on forms

Define monitoring plans to review all patients or random subsets with form flagging capabilities

In-depth interactive reports allowing modification of charts and display of general and detailed metrics

Real-time study overview with dynamic dashboards that update based on user selections

Report drug supply data at any time during the study

Dashboards and reports for tracking patient recruitment and accrual metrics

Dashboards providing metrics about subject recruitment, data queries, audit trail, data collection progression, and status tracking

Authorized users can unblind patients in medical emergencies with all events tracked in audit trail

Automatically schedule follow-up visits based on study protocol with date range validation and warning systems

Visit scheduler with monthly, weekly, and daily calendar views plus built-in task list for visit coordination

Configure visit scheduler to include ad hoc appointments not part of standard visit structure

Automated SMS and email reminders for scheduled study visits with tracking

Secure individual data entry fields so only authorized users can access those fields

Fields that are only accessible to authorized users for confidential data protection

Super-administrator access can be executed by Dacima Design Team or principal study manager

Create users and user groups with access control to studies, sites, forms, dashboards, and extractions

Ability to add dynamic visits for patient registries and trials without fixed follow-up visit structures

Create hybrid study designs combining fixed visit structures with dynamic visits for unscheduled visits

Registry designs with higher level grouping events for complex study structures

Built-in workflow and version management allowing creation of new form versions even after study goes live

Automatically compare locally stored and server database and upload only changes for optimized low-speed internet access