“Indeed, it is a bit of a black box. We wait for three weeks, and then something comes out of it, and then we have to say hold on. How did you turn our request for a boat into a bicycle?”
“We have a system designer, and then a validation group, and then a translation vendor, and a licensing group. It’s a lot to manage”
These are the words of two separate pharmaceutical executives talking about the process of building clinical trial systems that occurs prior to launching a trial. Recently, Medable worked with a leading market research consultant to identify the pains and processes that sponsors and CROs encounter when building trials. Of the many that were presented, one issue kept reappearing, the back and forth processes for building COAs.
This feedback was instrumental in the development of Medable Studio, which was built to simplify the study build process, take eCOA off the critical path, and give sponsors and CROs total control over the trial build process.
In fact, Medable had the opportunity to work with a new clinical research organization (CRO) client just after launching Studio. The client, who had run hundreds of trials before, was used to the traditional approach of building clinical studies from paper-based documentation. They stated that this process used to "take weeks," as they needed to describe their requirements to a vendor, who would then code it. The client would then work with the vendor's coder until the solution met the specifications.
Simply put, clients may "ask for a boat and get a bicycle," communicating back and forth to correct the specifications until it's precisely as requested.
However, with Studio, a process that typically takes weeks was accomplished in a single day. Here's how we did it.
A new approach: people, process, product
In November, we upgraded Medable Studio with its latest AI features. That update enabled Studio to read any client’s clinical trial documentation and generate a build in real time. From there, users can tweak anything within the study build as they see fit. As such, we used the client’s documentation to generate a study build almost instantly and conducted review sessions that facilitated immediate feedback and real-time adjustments.
This allowed us to secure client signoff during these sessions, speeding up the process exponentially. Additionally, the direct visibility into the development process strengthens communication clarity between teams and clients, eliminating misinterpretations that previously caused delays and revisions. Studio’s interface has streamlined our production pipeline by breaking down traditional barriers between conceptualization and implementation while significantly enhancing collaborative efficiency.
The benefits of control, transparency, and ease of use
The impact was immediate and measurable. We completed the kickoff on Wednesday and received the client's sign-off on Thursday. They were pleased with how quickly they verified that specifications matched implementation and that there were no gaps between expectations and delivery.
While the rapid turnaround is impressive, the real benefits are control, transparency, and quality. With Medable Studio's latest updates, clients get precisely what they specify, every aspect of the study is visible within the system, and the final product perfectly matches requirements.
The feedback has been overwhelmingly positive, with the client describing us as "one of the best management vendors we've worked with" due to the experience.
You can see the impact of this process here, with this blinded quote from a Studio client:
"I'd like to take a moment to sincerely thank you and the broader Medable team for bringing everything together! As I shared during our call, it was truly a collaborative effort, and the entire process was very efficient. You explained the steps clearly and ensured that we stayed on track with our commitments to achieve the study timelines while optimizing an efficient build for our future study participants.
I valued your team's responsiveness and was also impressed with the minimal number of bugs in the initial set up, which allowed us to only need to complete 1 round of UAT. Thank you again, and I look forward to continuing our collaboration!"
Sr. Clinical Trial Manager, major biotech
See a two-minute demo of Medable Studio here: https://info.medable.com/Book-a-demo.html
Conclusion
This combination of innovative technology and personal approach has helped us further refine our communication, implementation, and process. When clients can see what they're getting immediately within the system, everything becomes much more manageable and far less stressful, as specification, build, and signoff become a seamless continuum rather than disconnected steps.
