The eClinical Quicksand: Documentation

If you’re a clinical trials professional, you know the feeling. You’re project is cruising along nicely.   The protocol is written, the plan laid out, contracts signed, sites chosen and your eClinical projects are ready to execute.   Then, the equivalent of Tolstoy’s “War and Peace” lands in your inbox.   Only the title is different, “eCOA/ePRO Requirements and Specifications Document.”

A big outline becomes a huge set of requirements.   You now have two feet planted in quicksand and you form a human chain with your colleagues to try to get you out.    It's a time consuming, tedious, frustrating process that slows the project down.

OK, we know that eClinical project documentation is an important part of the process.   It's a key component to any mature SDLC (Software Development Life Cycle) and ratifies agreement on how the subject diary needs to work.  It helps CRO’s and sponsors to think about how to best reflect the protocol’s stated objectives in eCOA form and specifies behavior like edit checks, navigation, complex logic and even look and feel.   Struggling only sinks you further in the sand, so you grit your teeth and put in the work.  Out of the sinkhole!

What if you forgot something? The first patient will be enrolled in a week and UAT (User Acceptance Testing) is tomorrow!  Here comes the dreaded change order and a requirements/specifications revision.  Out of one sinkhole and into another.

Is there a better way to get out of the documentation quicksand?  What if we could just avoid the sinkhole altogether?   Altavoz Sculptor allows CRO’s and Sponsors to build their own eCOA/ePRO solutions using a simple and intuitive ‘drag and drop’ interface.   As you design your diary, your requirements and design documentation is automatically created in real-time, so your documents reflect the exact design and behavior of your beautiful eCOA creation.  If there is a last minute change, you only need to configure the change in Sculptor.  That’s it! Your documents automatically reflect the update and are ready for signature.

With modern technology, we can change the way eClinical projects are built and deployed, while increasing quality and decreasing the time and expense.  Let’s trade the quicksand of the desert for the serenity of the beach.

Interested in learning more or seeing Altavoz Sculptor in action?   Contact us to schedule a demo or become a Certified Altavoz Sculptor today!

Shae Wilkins