Clinical Trial Database Design: Behind the Scenes for a 6-8 Week Launch

How long should it take your data management CRO to go from receipt of final protocol to database go live? Here at PharPoint, our standard database build timeline is about six to eight weeks.

So what does the process look like behind the scenes?

Upon receiving the finalized protocol, PharPoint’s data management and database programming teams work closely together to begin building electronic case report forms, or eCRFs. eCRFs are digital, typically web-based, protocol-driven questionnaires used to collect specific study data during a clinical trial.

The primary purpose of eCRF design is to preserve and maintain the quality and integrity of data. eCRF production often includes collaboration with biostatisticians and clinical operations teammates to ensure all unique end goals are considered during database design.

At PharPoint, eCRFs are typically produced, internally reviewed, and delivered to the client for their review and approval in 10 business days, depending on protocol complexity.

For a typical project, a lead database programmer is assigned as the build’s primary architect. PharPoint’s in-house programming team are all US-based employees that have deep familiarity with several EDC systems, including Medidata Rave and Medrio.

One unique aspect of PharPoint’s workflow during database build is how we approach initial eCRF development and review.

Rather than providing a spreadsheet of specifications for eCRFs, PharPoint’s team programs the unique eCRFs up front and delivers them with annotations for sponsor review and approval. We’ve found this approach helps streamline review by providing sponsors with a more intuitive sense of how the final product might look.

Following the full approval of unique eCRFs, our team begins building visit structure and database structure.

For studies without complex integrations or external vendor dependencies, our team completes this entire process, both build and review, in approximately five business days.

At this point, screens and structure and functionality of the database are complete, so are we ready to go live? While it’s possible to go live at this point, the PharPoint team typically recommends go live to occur with edit checks in place. This ensures data will be cleaned the minute it hits the database.

That said, if the database is needed due to a planned first patient in, a split go live can easily be utilized. Now let’s discuss PharPoint’s process for the creation of custom edit checks.

A typical study has somewhere around 400 edit checks. However, this number can range significantly, as it is not uncommon for complex studies to have upwards of a thousand.

The edit check process begins with the creation of specifications. Edit check specification planning relies on multiple sources of information, including the study protocol, the data management plan, finalized eCRFs, and collaboration with other functional experts.

Once edit check specifications have been approved by the client, programming begins. PharPoint typically completes edit check programming and user acceptance testing in approximately 12 business days. At this point, the database is ready for final sponsor approval and go live.