In my R&D role at Endo Pharmaceuticals, I have seen the lines between operations and clinical data functions becoming more and more blurred. Specialized technical skills are vitally important and they become ever more valuable when the people who possess them come together to work on solutions in a facilitated, collaborative environment.
We presented BioClinica with a challenge in October 2013:
- Provide an EDC solution that enables studies to be built in an accelerated way without compromising focus on site needs.
During our initial meeting, BioClinica identified an immersive, collaborative UAT as a vital component to success. We welcomed the concept as it fits well with our own vision and aligns with the five basic tenets that guide our clinical trials:
- Collect no more data than we can consume. (This means managing ourselves to not do that!)
- Consider the impact on sites first and the needs of the study team second.
- Avoid the 100% default for SDV and queries.
- Maintain data standards in agnostic format (CRFs use CDASH; dropdown choices use standard terminology and display relevant options; clinical data and metadata is exchanged in a system-independent format, i.e. ODM xml)
- Eliminate waste, accelerate build, and stay nimble!
Solutions & Results
That immersive, "killer collaborative UAT" proved central to rapid study start up. It collapsed the entire process, and eliminated the typically time-consuming back and forth exercises.
In the four studies we initially presented BioClinica, a 100% delivery success rate for rapid study build was achieved. This included building two higher complexity Phase 3 studies in parallel. We followed a three-step process. We began by building the first study in its entirety and then built the unique components of the second study. From there we copied over common forms, once they had stabilized, in order to minimize duplicate effort.
We referred to data flow diagrams created by Jagadish Kumar, our informatics and programming manager at Endo, for a graphical illustration of all data sources and transfer systems involved in each of the studies. Keeping that complete picture top of mind helped us make decisions about where individual data elements would be captured (e.g. CRF or IRT) and forced us to acknowledge and solve for potential duplications.
Another critical time-saving factor was incorporating the use of CDISC standards into the study build process right from the start. Before we initiate any study build, Jagadish populates a detailed data map using a study modeling tool that conforms with the CDISC ODM Model. Drop down choices for standardized variables are built from published, up-to-date, controlled terminology. Then, the Endo team "walks through" the map, making sure we understand all sources and uses. As we completed the study builds, with BioClinica’s data management experts enhancing the specifications and associated edit checks, we all kept the end in mind ─ the SDTM data.
BioClinica’s immersive UAT process reduced the number of data points requiring verification. While our organization does 100% SDV, there is far less D to SV!
In addition to achieving accelerated delivery, working with BioClinica:
- Increased stakeholder intimacy with the database;
- Instilled confidence in the person performing in our new hybrid monitor/data manager role
- Enabled us to keep data standards housed in our own library; and
- Served as a foundation for future risk-based monitoring programs
What Did it Take?
Effective collaboration between BioClinica and our team was essential. Both sides came with the right attitude. BioClinica cared about how we wanted to work. They made a schedule with built-in touch points and the "killer collaborative UAT" that brought our teams together with all the right tools and people in a great work environment in their Audubon office. Clinical data, operations, programming and monitoring perspectives were represented in the room. We quickly established a rapport that grew into a rewarding working relationship. In addition to their investment in face time, we were given the necessary resources and were guided by disciplined project management.
In these meetings, we avoided burdensome agendas and documentation — except for the things that really matter. At each step in the process, BioClinica clarified exactly what we wanted. Not only did this eliminate misunderstandings and faulty assumptions, but also kept quality high and condensed the timelines.
Overheard in the UAT War Room 1
- "The body systems in the standard p/e form do not match the protocol…"
- "Our monitor is smarter than the CRF."
- "The TLF will look weird if that column is blank"
- "Wow! You made that change already?"
We were able to implement and review UAT changes on-the-fly. The BioClinica team made the changes we requested as we watched on a big screen. It is hard to describe just how valuable it was to have a form layout one might have imagined and then failed to accurately describe, be instantly translated into a visual. This allowed us to see the form, try it out and make changes to get exactly what we wanted. The BioClinica team did a lot of analysis on circumstances to test whether edit checks could be eliminated everywhere possible. All told, we estimate weeks were shaved from the schedule.
This is a repeatable process — one that aligns with our approach to data quality management. We did it four times so we know it will work for other studies. We know it works when we collaborate with BioClinica because their people show us repeatedly they care about our goals as much as we do. We achieved our goals and enjoyed the experience!