Electronic Data Capture (EDC) solutions have been used for a couple of decades now with more systems available today than one can count. From the big, well-known EDC providers, to the small not so well known vendors, to homegrown EDC solutions only used internally by some researchers, the features and functionality offered by each of these EDC systems vary greatly.
Selecting an EDC solution has become a complicated effort and one task that most Pharma/Biotech/CRO companies dread. Many just stick with the long-standing EDC providers that they’ve always used. Many 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 an additional EDC system to those systems currently offered, here are 6 considerations for selecting an EDC solution that you should take into account (in no particular order).
- Ease of System Administration
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 out to your team. The ability to administer these basic EDC system admin tasks when needed will keep you from having to go back and forth with the EDC vendor and paying for basic administrative services that you should be able to complete yourself.
- Flexible Hosting Options
Most EDC vendors only offer SaaS or Cloud hosting models, forcing you into long-term contracts for hosting. This is ok with most clinical research companies, as they don’t have the IT resources available to host themselves. However, many are hosting other internal systems already and have the IT expertise and datacenter infrastructure available. The EDC vendor should be flexible enough to allow both on-premise hosting by the customer as well SaaS or Cloud hosted solutions.
- End User Usability
Your EDC solution should be update to date with the latest technology. It should look like an application from 2017, not some old antiquated technology from 10-20 years ago. The interface should be intuitive for end users and take advantage of automatic workflows. Today’s EDC systems should support all web browsers across any platform and not restrict a user to a certain browser.
- Access to Data (Reports and Exports)
It’s all about the data. Having easy and instant access to your clinical trial data is a major consideration. The EDC system should be able to provide real-time data in multiple formats, such as through online reports, or through Exports in Excel, SAS and other file formats. You should be able to connect online and retrieve the latest data from your clinical trial any time you need it. You should not have to put in a request to your technology vendor and wait a week or more to get your clinical trial data.
- Simple Study Design
An EDC system from today should allow you to be 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 with no programming or advanced IT skills involved. Any data manager should be able to fully build-out an EDC study and administer it from study start-up through completion. Another important aspect to keep in mind is support for CDISC/CDASH and being able to store eCRF forms and codelists in a library to be easily reused for future clinical studies.
Pricing is possibly one of the biggest drivers for those selecting an EDC solution, or any technology platform for that matter. This does not necessarily mean you should select the vendor with the lowest pricing. Also, the highest priced EDC solution does not necessarily mean that the solution is the best. You should select a vendor that offers you a complete EDC solution, with the flexibility to implement various modules of the EDC system, have full control over administering and controlling your EDC environment, all at a price that corresponds to the value received. The total cost of ownership should be considered, which includes the system implementation, training, support through out the life of the study and the software licenses. Many vendors make as much money on supporting the EDC system throughout the study, supporting eCRF updates and study amendments as they do on the initial implementation costs.
Ennov is a leading Life Sciences technology vendor with solutions across 4 primary areas including 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), Electronic Trial Master File (eTMF), and eLearning solutions. Ennov EDC includes several supporting modules that make the system one of the most complete available on the market today. These supporting modules to Ennov EDC include: EDC Mobile (iPad app with online/offline capabilities), Randomization and Trial Supply Management, Monitoring, Medical Coding, Data Import/Export, and Double-Data Entry (for paper studies).
Interested in learning more about the Ennov Clinical platform? Join us for our Introduction to Ennov Clinical webinar on Tuesday, 14 November 2017 at 11 am EST. To pre-register for the webinar click here.
Phillip Strickland is a Clinical Solutions Consultant with Ennov, based in North Carolina, USA. He has over 16 years of experience with the validation/testing, project management and project implementation of various eClinical technologies (EDC, CTMS, ePRO, eTMF, RTSM). You can contact Phillip at firstname.lastname@example.org.