Sponsor (pharmaceutical, biotech, medical device) companies use Electronic Data Capture (EDC) systems to collect and process clinical trial data. It is a common practice for these sponsor companies to contract out the build process for these studies to an outside vendor, such as a Contract Research Organization (CRO) or consultants specializing in study builds.
A study build involves creating the Case Report Forms (CRFs) in the EDC system, configuring data integrity rules (edit checks or Conditional Actions) on those CRFs, creating sites and users in the system, and configuring other functionality such as randomization and role security. Here are five advantages for sponsors to build their own study in EDC.
1. You don’t need to be a programmer
The days of navigating through complex code to achieve basic functionality are over. Knowledge of the underlying HTML code is not required to create great web pages, thanks to modern web design software. Similarly, with modern EDC systems such as Clinical Studio, you simply use the drag and drop interface to create CRFs and configure edit checks.
2. You know your product best
As a sponsor, you know best what data is relevant to collect and which data integrity rules should be implemented for maximum effect. If there is a particular oversight during the specification process, it can be detected during the study build IF the build is being done by a person who knows and understands the drug/product/therapy being tested in the trial.
3. You’re already answering all the questions asked by your CRO or vendor
Assuming that your CRO or vendor is actually doing a thorough job of reviewing the specifications, they will come across questions that they do not have the answer to. Related to the point above, they will ask you, the product expert. Make the process more efficient and do the build yourself. This leads us to the next point.
4. Simple changes should be made fast
Any sponsor familiar with the traditional model of outsourcing the EDC build is familiar with the frustration of making simple changes on an EDC system you have no control over. High price tags, long implementation times, or both frustrate sponsors who sometimes sometime ask, “How much does it cost to update a label?!? And why does it take so long?”
5. Spend the budget on more productive fronts
In this day and age, is the best use of your budget to hire an administrative assistant to hear you dictate a letter and then go type it up in Microsoft Word? In the same vein, is it the best use of your budget to hire somebody to create a study in EDC after you have spent the time to create the specifications yourself? And if any questions come up, you are the one that answers them anyway? Clearly not, especially given tools such as Clinical Studio, which empower you to build and configure your own EDC study without any programming.
Okay, so there is actually a sixth reason. It’s fun and empowering! Schedule a product demonstration to see for yourself how simple it can be.