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.
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:
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.
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.
The visit scheduler can also be configured to include ad hoc appointments that are not part of the visit structure of the study.
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.
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.
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.
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 (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.
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:
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.
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.
Dependencies and piping:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
21 CFR Part 11
Dacima Software complies with FDA regulatory requirements:
All products of Dacima Software are compliant with HIPAA.
Dacima Software conducts its processes following Good Clinical Practice guidelines.
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.
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.
“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.”
Dacima Clinical Suite integrates with Rybbon, a digital gifting platform that lets you automate and streamline the rewards fulfillment process.
Now you can automatically send rewards to participants who have completed your trial or study rather than managing the process manually. They’ll get to choose incentives like e-gift cards, Visa and MasterCard Prepaid cards, or charitable donations. And with rewards that can be redeemed in more than 150 countries around the globe, you can incentive participants no matter where they live.
Dacima Clinical suite integrates with SaleForce to automatically transfer your SaleForce contacts mailing information to Dacima Clinical Suite web survey and electronic Patient Reported Outcomes (ePRO) mailing list feature for sending study subjects invitations.
Dacima Clinical Suite offers Application Programming Interface (API) Web services for integration with third party system for automatic data transfer.
Dacima supports ODM version 1.3 for clinical data POST and metadata POST and GET requests.
ODM is represented as an XML document and consists of a hierarchical tree of elements. These elements may have attributes which define their features. Elements and attributes in the Dacima Web Services API follow the CDISC ODM 1.3 standard and the ODM 1.3 rules on the hierarchy of elements.