By: Lauren Sims
As the Clinical Trial process has continued to improve over the last several years, the benefits of using an EDC system has become widely known throughout the industry. Organizations are more familiar with the basic functions of their EDC and are learning what to expect from the software. This includes form design options, data entry and cleaning options, query management and the ability to export data. This now common knowledge leaves many looking for the next step to improve their workflow, while considering the cost of adding new tools and processes, and the potential challenges they’ll face while implementing them.
One way to continue to move forward while addressing these difficulties is to implement a single platform that not only covers the basic functions needed, but provides access to other solutions and security. Using a more comprehensive EDC tool, where all of the features can be found in one place, will also provide data in a central location. There are wide ranging opportunities for cost savings as well, as processes are streamlined with the use of a single system.
Staring with the basics, your EDC tool should include:
- eCRF Designer – The ability to design studies with a user-friendly option that includes a variety of field types and templates.
- Data Review – Source Data Verification and data cleaning workflows to identify and correct errors in the data.
- Query Management – Options to identify, track, and resolve questions or discrepancies in clinical trial data.
- Data Export – Options that allow study data to be exported out of the system.
- Reports – Standard and Ad-hoc Reports
In addition to these basic functions, a more comprehensive EDC system will provide these additional products and features:
- Easy Mid-Study Change Implementation – The process to implement mid-study changes should be simplified with your partner and system, and you should never expect downtime when changes are applied. This is helpful as updates can be done quickly with no impact to the sites or patients.
- Randomization and Trial Supply Management – Having supply management and randomization built into your EDC tool provides the most convenient option. Beyond that, you should have the ability to implement simple or complex randomization schedules to fit the need of each trial. The inventory management option should allow for tracking of drug assignment and containers, as well as shipments.
- ePRO/eCOA/eConsent – Implementing an ePRO solution to capture eCOA and eConsent is one of the most valuable investments an organization can make. This enables virtual participation by collecting information on an app from wherever the patient is, giving you opportunities to conduct clinical trials that go beyond site visits. Patients should have access to forms that are easy to read and complete. These may include video, pain scales, slides, multiple-choice and other helpful options. They are notified when forms are due and have the ability to submit data at any time. Even better, the data will be immediately available to clinical staff.
- Centralized Cloud Database - Cloud storage as a part of a single tool is going to have several advantages. It is important because it allows data to be centrally accessed from multiple systems at any time. That accessibility will provide the most convenient option and the most effective data sharing opportunities for the team. Each time a change is made to data it will be updated across all of your products and made available right away. The EDC tool should also have appropriate encryption and regulatory related compliance standards to ensure that you are not compromising the care and well-being of your participants by exposing their data.
- Imaging & Endpoint Adjudication –Data files should be accepted from both users and systems as a part of your EDC solution. Once data is available, it should be immediately available for metrics on image anonymizations and assessments. The system should also provide the ability to define workflows for endpoint adjudication and review based on the individual study requirements.
- Easy Communication Channels – These options should be robust and allow users to communicate with both patients, clinical staff and study teams easily. Options should include the ability to create and send e-mails to designated individuals or groups on a whim, but also allow for scheduled and automated emails to be sent, with reporting and analytics included as needed. The opportunity to send notices or reminders through the app to patients provides an added benefit and virtual communication option for them.
- Medical Coding – Access to the MedDRA and WHO Drug Dictionary Codes should be available, along with the ability to import, add or maintain data entry values and assign the appropriate codes as needed. The platform should provide the ability to assign synonyms for existing entries to improve efficiency in the trial. It should also give users the ability to identify values or entries which are not matched with a code and find/apply the appropriate code easily.
- CTMS –A CTMS solution will improve visibility when managing resources across multiple studies and also provide insight into a variety of data sources for clinical management and forecasting. The option should be easy to use, empowering users to take control through the use of customized forms, reports and exports. Users should be able to simplify regulatory submissions and eliminate data redundancies all while increasing monitoring of productivity.
With these options, you are able to provide immediate access to data throughout your organization from a single, secure, cloud-based database. The system should offer a cost-effective solution with a single partner and also support mid-study changes with ease.
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