Electronic data capture in clinical trials has been used for a couple of decades, with more EDC systems available today than one can count. From the big, well-known EDC providers to smaller vendors and homegrown EDC solutions used internally by researchers, the features and functionality offered by each system vary greatly.
Selecting an EDC solution has become a complicated effort and one task that many pharma, biotech, and CRO companies dread. Some stick with the long-standing EDC providers they’ve always used. Others go with the flashy, well-marketed systems that spend millions on advertising and trade shows.
If you are looking to implement a new EDC solution or add another EDC system to those currently offered, here are six considerations for choosing an EDC solution (in no particular order).
1. Ease of System Administration for EDC in Clinical Research
Are you able to have full control over administering your EDC system, or do you have to turn to the EDC vendor for such services?
Being able to fully administer all users, roles, privileges, and study access should be a function extended to your team. The ability to administer these basic EDC system tasks when needed will keep you from having to go back and forth with the vendor and paying for basic administrative services that you should be able to complete yourself.
For organizations using EDC in clinical research, having direct control over system administration helps reduce reliance on external support.
2. Flexible Hosting Options
Most EDC vendors offer SaaS or cloud hosting models, often requiring long-term contracts for hosting. This is suitable for many clinical research companies, as they may not have the IT resources available to host systems themselves.
However, some organizations already host other internal systems and have the IT expertise and data center infrastructure available.
The EDC vendor should be flexible enough to allow both on-premises hosting by the customer and SaaS or cloud-hosted solutions.
3. End User Usability in EDC Clinical Trials
Your EDC solution should be up to date with modern technology. The interface should be intuitive for end users and take advantage of automated workflows.
Modern EDC systems should support commonly used web browsers across platforms and avoid unnecessary restrictions that require users to work with a specific browser.
When evaluating EDC for clinical trials, usability is an important consideration for clinical research teams working across different sites and locations.
4. Electronic Data Capture: Access to Reports and Exports
It’s all about the data.
Having easy and instant access to your clinical trial data is a major consideration when selecting an electronic data capture solution.
The EDC system should be able to provide real-time data in multiple formats, such as online reports or exports in Excel, SAS, and other file formats.
You should be able to connect online and retrieve the latest data from your clinical trial whenever you need it. You should not have to submit a request to your technology vendor and wait a week or more to receive your clinical trial data.
5. Simple Study Design
An EDC system should allow you to remain in control of your trial.
Through an intuitive interface, you should be able to easily design your eCRFs, create edit checks, define the visit structure, and set up various dynamic rules and notifications.
All of this should be possible without programming or advanced IT skills. Any data manager should be able to fully build out an EDC study and administer it from study startup through completion.
Another important aspect to keep in mind is support for CDISC/CDASH standards and the ability to store eCRF forms and codelists in a library for reuse in future clinical studies.
6. Pricing
Pricing is possibly one of the biggest drivers when selecting an EDC solution or any technology platform.
This does not necessarily mean you should select the vendor with the lowest pricing. Likewise, the highest-priced EDC solution is not necessarily the best.
You should select a vendor that offers a complete EDC solution, with the flexibility to implement various modules, maintain full control over your EDC environment, and access the functionality you need at a price that corresponds to the value received.
The total cost of ownership should be considered, including system implementation, training, ongoing support throughout the study, and software licenses.
Many vendors make as much money supporting the EDC system throughout a study, including eCRF updates and study amendments, as they do from the initial implementation.
About Ennov Clinical
Ennov is a life sciences technology vendor with solutions across four primary areas: Clinical, Pharmacovigilance/Safety, Regulatory, and Quality.
The Ennov Clinical platform includes Electronic Data Capture (EDC), Electronic Patient Reported Outcomes (ePRO), Clinical Trial Management System (CTMS), and Electronic Trial Master File (eTMF).
Ennov EDC includes several supporting modules that make it a comprehensive solution for managing electronic data capture in clinical trials. These supporting modules include:
- EDC Mobile (iPad app with online/offline capabilities)
- Randomization and Trial Supply Management
- Monitoring
- Medical Coding
- Data Import/Export
- Double-Data Entry (for paper studies)
Interested in learning more about the Ennov Clinical platform? Reach out to our team.