Features

Dacima’s flexible and easy-to-use Electronic Data Capture software comes with advanced features!

Dacima Software’s products include all of the below listed features. Our flagship software is the Dacima Clinical Suite which is an innovative, powerful and flexible web based Electronic Data Capture (EDC) software with a variety of features and capabilities that let you design manage and collect your data through a user friendly and intuitive web-based graphical user interface.

We could talk for hours about our software so we listed the most important features in the topics below. Click on each of these features to open up the toggle-down page for more details.

Study Design

Form Designer

Designer module

Dacima Clinical Suite has a powerful designer module that lets you design electronic Case Report Forms and questionnaires without the need for programming expertise. Though a user-friendly web interface you can configure the studies global parameters and create custom form. Design simple forms or using the many advance design features you to create sophisticated data entry forms with capabilities and data types not found in other EDC software. Dacima gives you more design flexibility and options than any other EDC software. Built in workflow  and version management allows you to create your study databases and  moves them to testing and production and version management allows you to create new versions of the forms even after the study has gone-live.

No programming required

The Designer module allows you to created professional databases with no programming required.  Through an easy to use graphical web interface you can access many design features and options not found in any other EDC applications. Dacima offers greater flexibility and design capabilities. All EDC system allow you to create basic data types, but only Dacima offers more advanced data types and options to give you the flexibility you need.

Advanced design features include:

  • Dacima’s Designer module offers options that allow you to tailor your database for all kinds of different study designs: Clinical trials, observational studies (cohort, cross-sectional, case-control), patient registries, post-marketing studies, ePRO, patient diaries, web surveys and telephone interviews.
  • Next generation of advanced form design data types that allow you to create the most user-friendly and intuitive forms, including:
    • Subform to embed a form as a dynamic grid tables to collected as many rows as needed by subject,  or display in form view.  Option to link and filter different subforms based on data already entered.
    • Design static tables with ability to move table cell position with the click of the mouse and merge options let you combine cells to create tables that look like you paper design.
    • Panels allows you to split you design screen into different sections
    • Modal popups and list popups that makes collection complex data simple and intuitive.
    • Image based data entry lets users enter data by clicking on zones of the images.
  • Fixed list and adaptive randomization options.
  • Partial date data type with option to impute missing date parts.
  • Wide variety of design parameters and options that allows you to tailor the workflow to your requirements and not the other way around.

Dynamic Visit Structure

Visit setup

In addition to setting up studies with fixed/predefined visit structures for longitudinal designs, Dacima also offers the ability to add dynamic visits that lets you add as many visits as needed for individual subjects. Dacima’s dynamic visits functionality is designed for patient registies or for trials that do not have a fixed follow-up visit structure.  Dynamic visits allows you to add a subject visit at any time based on the date of the visits.  

Hybrid visit structures

The system also allows you to create hybrid study designs with a fixed visit structure and an dynamic visits which can  be added for the subject as needed (such as for unscheduled visits in trial).  The designer module also allows you to choose from the standard subject selection interface or a dynamic visit interface designed specifically for patient registries that require dynamic visits.

Subject Scheduling

Automatic scheduling
Subjects follow up visits are automatically scheduled. The scheduler projects the visits based on the study protocol and allows you to confirm it as a scheduled visit or change it as needed. With the built in date range the system also display the acceptable visit date window and displays warning for visits scheduled outside of the acceptable date range.

Calender views with tasks management
The visit scheduler allows you to view monthly weekly or daily views as well as a subject complete visit schedule. Built in “task” list help you coordinate and manage the subjects visits.

Custom configuration
The visit scheduler can also be configured to include ad hoc appointments that are not part of the visit structure of the study.

Multi-Stage Enrollment

Hybrid inclusion forms
Dacima’s flexible design features allow you to create single forms or multiple forms for multi-stage subject inclusion/enrollment. In a single form design the subject is included in the study database when the inclusion form is completed. Multi-stage designs allow you to create more than one inclusion forms which are completed sequentially.

Status tracking
The system tracks the status of the subject in the inclusion process. For example, an initial form can be used for the preliminary screening, and then followed by a second eligibility form that is completed after the results of lab tests are received. Once the stages are completed the subject can be randomized. At each step in the process the system tracks the status of the inclusion forms.

Image Based Data Entry

Create clickable fields on any image
Dacima’s unique image based data entry feature allows users to enter data by clicking on regions or zones of an image. From the Designer module the user can upload images and then, using the mouse, define regions or zones of the image that then become data entry fields.  When the data entry users access the form they can then click on the predefined zones of the image to enter data. 

Dynamic subquestions
The system allows you for sub questions to appear based on the image zone that was selected and also allows for background colour of the zones to dynamically change based on the responses to questions on the eCRF.

Randomization

Randomization

Randomization (simple, block or permuted block)

Dacima Clinical Suite is extremely flexible and powerful Electronic Data Capture (EDC) software with an integrated, intuitive web randomization module that lets you seamlessly randomize subjects through any web browser. The randomization module (IWRS) is available as an integrated module within Dacima Clinical as part of a complete clinical trial database or it can be used for randomization alone. With configurable options you can design your randomization for blinded or unblinded trials, simple, block or permuted block randomization with or without stratification. Dacima lets you configure your web randomization with a few clicks of the mouse – easy, fast, efficient and flexible.

Features:

  • Choice of randomization methods (simple, block, permuted block, minimization)
  • Generate fixed randomization lists with the click of the mouse or import externally generated randomization lists.
  • Blinded or unblinded designs
  • Stratification
  • Multiple treatment arms
  • Eligibility forms and checks (single or multi-stage inclusion process)
  • Configuration option to include or exclude ineligible patients
  • Email notifications
  • Recruitment/accrual tracking dashboards and reports
  • Integrates with the Dacima Drug supply management module
  • Emergency unblinding modules allows authorized user to unblind patients in case of medical emergency. All unblinding events are tracked in the audit trail and accessible in reports including the user, date and time of unblinding.

Adaptive Randomization / Minimization

Dynamic Randomization Lists
Dacima’s Randomization module includes an integrated Minimization functionality that uses adaptive randomization techniques designed to reduce imbalances of prognostic factors between treatment arms. The software include different configuration options and features, including:

  • Naive minimization and Biased-coin minimization
  • Option to set base probability
  • Choice of distance measures for computation of imbalance scores (marginal balance, standard deviation, range and variance)
  • Addition of prognostic factors with weighting options
  • The software allows you to run simulations during development
  • Computation of ongoing randomization statistics (total and by prognostic factor) and imbalance scores

Drug Supply Management Module

Specifications:

Dacima’s study Drug Supply Management module fully integrates with Dacima’s web randomization (IWRS) module to allocate drugs to newly enrolled patients and for resupplying patients with drugs. The module designed to track study drug supply at the study sites and automatically notifies the main pharmacy and distribution centers when the site inventory level is low and requests shipments of new inventory.

Functionalities:

  • Configurable product drug names and product codes by study arm.
  • Option to create of distribution centers (e.g. by city, region or country).
  • Configurable resupply trial specific reasons.
  • Customizable supply levels and low inventory level thresholds values for triggering automatic drug supply requests for distribution centres and study sites to ensure sufficient stock availability at the distribution centers and study sites.
  • Configuration of patient drug allocation reasons for initial allocation and for subsequent resupplying.
  • Stock codes upload with option to manually generate site supply requests.
  • Automatic email site drug resupply requests sent to the central distribution center (pharmacy).
  • Consignment completion and shipment tracking by Main pharmacy and distribution centers.
  • Study site shipment receipt tracking.
  • Automatic dispensing code (bottle number, kit number, etc.) assignment to patients based on study arm allocation.
  • Expiry date management ensures that only drug that are not expired or will not be expiring during the treatment period will be assigned to the patients.
  • Automated site shipment algorithms that can be adjusted to your study needs throughout the clinical trial
  • Automatic dispensing code (bottle #, kit#) status tracking with ability to manually update status for missing damaged or lost inventory.
  • Reporting of drug supply data at any time.
  • Permission based access to features allows you to manage access to the different functionalities based on the users job requirements and duties.

Clean and Easy Data Capture

Real-time Validation Checks

Dacima Clinical Suite allows you to configure simple or complex validation checks through and easy to use web interface. No programming expertise required. With many built in functions the software allows you to setup advanced validation controls.

Validation rules:

  • Field level (missing values and ranges)
  • Validation checks across items on the same form
  • Validation checks across items on different forms

Dependencies and piping:

  • Visible and enable skip patterns within the same form or across different forms
  • Colour dependencies let you change background colours to highlight questions dynamically
  • Dynamic table rules to trigger allowable rows in dynamic tables based on other values entered.

Offline Data Entry

Capture data in remote location
Dacima’s offline module facilitates a more efficient approach for electronic data collection in regions lacking web connectivity. The offline mode combines the benefits of web electronic data capture with that of a distributed offline database system. The system automatically generates a client application from the web database, replicating the interface of web database with all the validation checks, form design features, data querying capabilities and data collection workflow of the original master web database.

Smart upload
Research staff can collect data electronically using the distributed database system without the need for internet access. When arriving at the clinical site/office, the software will compare the locally stored and server database and will only upload the changes that have been made to optimize low-speed internet access.

Create users and delegate rights

One superadmin
The superadmin access can be executed by the Dacima Design Team or can be given to the principal study manager. It allows to create users and user groups and give them access to studies, sites, forms, dashboards, extraction and more.

Delegate rights to have complete control over your study and everyone who accesses the database.

Item level permissions
Dacima Clinical lets you secure individual data entry fields so that only authorized users can access those fields. Protect confidential data and restrict access to only those users who require access tot he data.

Dynamic Form Activation

Form triggers
Form activation allows to tailor the study database to display specific data entry form(s) based on values entered in trigger fields. You can design the study to display different forms depending on the treatment allocated to the subject, or activate or hide specific forms based on a variable such as sex.

Interactive dashboards and custom reporting

Real-time study overview
The interactive Dashboards are designed to give you an overview of important study metrics and data. Dashboards are dynamic and update based on user selections.

Various metrics
Users can choose from a variety of dashboards that provide metrics about subject recruitment, data query tracking, audit trail events, progression of data collection process, status tracking and summary statistics.

In-depth reports
The interactive reports allow you to modify the charts and display review general and detailed metrics. The dashboards also allow you to easily and efficiently go directly to related reports and data entry forms with the click of the mouse.

Monitoring Module

Advanced study management
Dacima Clinical Suite’s monitoring and verification module allows monitor users to review data, add data queries for discrepancies and electronically sign off on reviewed forms. The monitoring module allows monitoring plans to be defined, allowing you to review all patients or a random subset, as well as specifying which forms will be flagged for monitoring. The system allows you to create multiple monitoring plans and tracks the status of the plans.

ePRO (electronic Patient Reported Outcomes)

Capture data from any device!
Dacima’s electronic patient-reported outcome (ePRO) module allows you to specify data entry forms for self-completion by the study subject. The module integrates with the Scheduler module and visit structure to automatically send subjects email reminders to complete the specified forms at the appropriate time.

Control your patient’s input
Status tracking and management features allow you to monitor the status of the questionnaires. Simplified ePRO interface allows for easy data entry by study subjects. Interviewer can activate the  forms form self-completion on a computer or tablet, or trigger an automatic email to the subject with an embedded link to the ePRO forms.

Web Survey Module

Dacima’s web survey module is the most powerful web survey software on the market with the flexibility and options that lets you design all types of surveys (marketing, customer satisfaction, patient surveys, physician surveys, population surveys and more). Dacima Survey only web survey software designed with features specifically for  medical/health research, including FDA 21 CFR Part 11 compliance, a complete audit trail, the ability to configure eligibility criteria form with checks, and ability to configure longitudinal survey designs.  The software allows you to design simple or complex web surveys, through an easy to use web interface. No computer programming required! Dacima Survey has features and options not available in other open source and commercial software.

Patient Diary

Dacima’s Patient diary allows subject to complete diary or regular log entries.  Accessible from computers, tablets or smart phones the Dacima’s diary module allows subjects to enter their data directly into the database through easy to use  web forms.  Automatic reminders ensure that subjects’ are notified if they fail to complete an anticipated entry.

Easy Access to Your Data

Data Importation Module

Dacima Clinical Suite includes the ability to upload external data files into the database. Automatic mapping of variables makes uploading easy and the simulator option you can test you importation to detect any potential data anomalies.

Advanced Data Extraction

Extract full database or subsets
Dacima Clinical Suite allows you to extract your data through a powerful data extraction module that lets you extract all the data or create subsets of the data through the built in filters.

Complex configurations
Configure and save your extraction parameters and re-run it whenever you need through our easy-to-use Graphical User Interface. Dacima Clinical Suite saves a history of all extractions and even provides warning if data sets have been updated after the extractions have been performed.

SPSS Code Generator

Dacima Clinical Suite includes a SPSS code generator as part of the data extraction functionality and the writes your SPSS import code, item labels and list value labels statements saving you time and simplifying data analysis. The feature dynamically generates the SPSS code from the meta database and creates syntax that corresponds to the parameters specified for your data extraction.

SAS Code Generator

Dacima Clinical Suite includes a SAS code generator as part of the data extraction functionality and the writes your SAS import code, proc format statements and SAS label syntax saving you time and simplifying data analysis. The feature dynamically generates the SAS code from the meta database and creates syntax that corresponds to the parameters specified for your data extraction.

Specialized Coding

21 CFR 11, HIPAA & GCP

21 CFR Part 11

Dacima Software complies with FDA regulatory requirements:

  • Comprehensive and complete audit trails that track all changes to study data, and all user access, actions, and sessions
  • Electronic signatures
  • Access restrictions to protected health information (secure fields allow access by authorized users)
  • Standard Operating procedures (SOPs) that protect data integrity and confidentiality

HIPAA

All products of Dacima Software are compliant with HIPAA.

    HIPAA, the Health Insurance Portability and Accountability Act, sets the standard for protecting sensitive patient data. Any company that deals with protected health information (PHI) must ensure that all the required physical, network, and process security measures are in place and followed.

ICH-GCP

Dacima Software conducts its processes following Good Clinical Practice guidelines.

    The Good Clinical Practices document describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCPs cover aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigator’s Brochure which had been agreed earlier through the ICH process.

CDISC Wizard

Through Dacima CDISC wizard you can create forms that allow you to generate SDTM compliant data. The easy to use wizard simplifies the setup of CDISC compliant forms by selecting domains and fields. Dacima also allow you to output study databases in ODM compliant format and import ODM snapshot or transactional databases into Dacima Clinical Suite.

MedDra

Dacima Clinical Suite integrates with the MedDRA dictionary and automates and simplifies adverse events coding. The system automatically searches the MedDRA hierarchies and preferred terms for the text entered in the  adverse event fields.  If adverse events codes are not found the system identifies uncoded terms and allows the users to added corrected terms. This powerful coding functionalities simplifies MedDRA coding.

WhoDrug

“The WHO Drug Dictionary Enhanced™ (WHO DDE) assist pharmaceutical companies and CROs to secure better clinical data, speed-up its analysis, and submit the results. It’s the most comprehensive and actively-used drug reference work in the world – an indispensible source of medicinal product information for drug development and safety surveillance.”

Other features

  • Built in standard reports or built your own ad hoc reports through the Dacima Query Builder
  • Form Library
  • Complete audit trail, build in data clarification forms and reports (data queries)
  • Powerful design features (subforms, modal popups, tables, upload images, upload files, and more)