It means different things to different people. To my kids, it's an avenue of social media and entertainment. To my parents, it's confusing but they keep trying it to connect more frequently with family. Especially in the last 2 years, it's a means to be able to continue our daily work.
Technology can make or break your workday. A bad connection on a call, an update that fails, a report that won't run, a system that doesn't retain 2 hours of data entry (UGH, right?!). Or it can run seamlessly, providing all of the information needed to conduct any job requirements. Could it also do the work for me instead of having to manually compute and analyze data?
Someone once told me during a product development session that it's like Christmas - tell me what you want and need the technology to do for you. Talk about opening up the "Creativity Lane!"
So here I go; I need a system that has automation, intelligence, and experience to do the work for us. The intelligence to put industry experience and knowledge into technology. For the data to feed from one area into another and back again. I want a system that automates what the risks are- both initially and then continually throughout the trial. I want to be able to see the risks and not have to perform a deep dive into a plethora of data to derive what my perspective of risk might be. I want it to scream and shout to me, glare at me in color, to tell me what I should be concerned about today (or not) and what the potential for risk is within the next three to six months.
And I want it to fit a phase 1 study in Oncology as well as a phase 4 study in Internal Medicine. I want it to tell me whether the risk is to a site, to data quality, to subject safety, to the potential for risk to my eTMF. Whew! Right now I sound like one of my kids with "I want, I want, I want," but I do want! Can you imagine the reduction of workload for what has traditionally taken trial leads basically an entire weeks-worth of hours to create risk planning and then the multitude of hours to monitor the data? It makes me tired to just think about it.
There are so many technology needs to run a clinical trial and even more than what was on my wish list. From regulatory and start-up, to site and subject-related communications, more eCOA than ever before, each business unit having its own tech demands. Add to that, the tracking of so many different components, bringing them together to make a cohesive and intelligent narrative that can be leveraged by each role to align with and even automate necessary next steps.
But can you trust the narrative? Where is the data originating? Is it siloed data manually derived and construed from one user's concept of the information needed vs data that matters? Or data that could matter if it was reviewed holistically vs from that siloed perspective? Or data that could be looked at from an AI/ML perspective that could reach further depths of understanding?
When you consider the abilities of such a system that provide automation, true data analysis, interoperability across risk planning, monitoring, resourcing, and content management, it provides a full risk management aspect. Why wouldn't you want such a system?
What if you only needed a portion of the system or wanted to start with a portion and build on it. What if you are mid-way through a trial, and issues are identified about safety and eligibility of subjects randomized (yikes!)? Do you have any recourse (besides thoughts of quitting your job and finding a new job on a Caribbean Island or standing up and yelling HELP!)?
YES! A resounding yes, at that!
This technology exists and it doesn't break the bank! It fits any therapeutic indication of any trial size in any trial phase. It can be set up on Day 1 of trial or protocol planning or mid-trial in a rescue study. It meets and exceeds regulatory requirements and automates where you thought automation wasn't possible. It's able to be used in parts or as a whole solution.
It's an intuitive, intelligent, interoperable, and scalable system, that by nature of being RBQM, saves costs, improves quality, and applies direction to the real trial needs. It identifies outliers within normal data parameters as well as outside the norm. It continues to advance in technology based on trial and therapeutic findings and analysis. It advocates subject safety. The system that ingests data to provide a detailed to holistic view of the trial. And it meets regulatory risk requirements. It’s a system that can provide cross-trial data against a portfolio of trials. There’s so much it can do and it’s right for you whether you are a Sponsor or a CRO. It’s the solution!
Next up: Integrated Monitoring as a Solution!