Munther Baara, Vice President of Product Strategy and Innovation at EDETEK, has more than 30 years of experience in the industry and was in Boston at DPharm 2023. He was there to talk about accelerating access to your digital data pipeline with Kris Kokomoor, associate director or data acquisition, clinical image, and specimen management from Pfizer Global R&D.
On the relationship with EDETEK, Kris said: “During our RFP process, we noticed there was another group of folks within Pfizer who were also talking about the exciting opportunities to consume electronic health records (EHR) and real-world data. We looked at how we might be able to align on a unified solution. In 2013, the US FDA released guidance documentation on e-source data to help, influence, and encourage the industry to move towards innovations. There have been a lot of disruptive innovations in data management that really disrupted the music industry and the movie industry and many others, but we were, as a group, slow to adopt them.
Redesigning data acquisition and infrastructure
“In 2015, we began to develop our set of requirements and how we might be able to reimagine and redesign our data acquisition and infrastructure. The result of that was we picked the best partner that we defined at the time and that is how we ended up with this this good relationship with EDETEK.”
Munther started his talk by asking who remembered the great fire in Baltimore.
He explained: “Everybody remembers the great fire took place, the fires that burned down on the whole of downtown Baltimore. Firefighters came from different states trying to put the fire out. Unfortunately, as the best firefighters stood aside and watched the fire, they did not do anything. Why? Because there was no standard. The fire hoses were different sizes compared to the fire hydrants in Baltimore so they could not hook up their fire hoses. They could not help.”
He asked whether this felt familiar within the industry with all the silos that exist throughout the clinical development lifecycle.
“Due to the silos that exist, stakeholders may not be aware of the status of their studies. Project managers or the study teams say ‘my study is green. Everything's perfect’. Then six months down the road, when they conduct the first DMC or the first interim analysis, the study suddenly becomes yellow, if not red, because this is the first time that they have put the data together.
He pointed out that there had been a lot of talk about the patient being at the center of the clinical trial. If we proactively aggregate data early on and eliminate the silos, we can identify and proactively flag any issues early in the study. In turn, you will see a reduction in protocol deviations, missed timelines and ultimately leading to more time to focus on the science and the patient.
He added: “I want to talk about moving the study from being sponsor-centered into patient-site-sponsor-centered and how we can achieve that through our solution.
“I'm proud to stand here with Kris, I wanted to do this three years ago, but I didn't do it because I didn't want to stand here as just another vendor without enough data to back me up.”
He explained that CONFORM, EDETEK’s Clinical Informatics platform, could make the data readily available for downstream consumption so that stakeholders can take proactive measures by seeing their data collectively all at once in near real-time. This is the differentiator.
Data collection in near real-time
He said clients should have expectations that things are going to work and that when they start their first study, there is no waiting around for six months to ‘hook up all the right wires’. “Our platform enables us to give sponsors the flexibility to create that orchestration, along with full data lineage, which is very critical as we start shifting the data collection from legacy data collection to direct data collection. Think about this, more than 75% of the study data is electronically sourced as we are moving farther away from the CRF standard way of collecting data and getting closer to the patient to collect the data.”
Munther said there should be a nice way to show sponsors the data lineage which is what EDETEK does now. Visually you can right click on any data points and see exactly where the data was collected and what additional transformation was applied. As a result, because the data can be spotted in near real-time, it can be acted upon quickly, which he said was a ‘huge difference’.
He said: “When the golden gate bridge was built to connect the different parts of San Francisco, whoever imagined that? Everybody said it's not doable and everybody crushed those behind it saying the whole thing is too big and you're never going to achieve that. And guess what, four and a half years later, they built the golden gate bridge. And you can see where we are now.
“I challenged my team with my aspiration or vision for the digital data pipeline to accelerate database lock to CSR from 148 days to three days. And everybody says ‘you're crazy, you're out of your mind. You don’t know what you're talking about because it will never be achieved. Get out of here.
“Yes, you can say that. But I aspire for that vision. And I think we will achieve it. And that's what I wish for the industry.”
Laughing at the audience reaction he added: “Wait! Okay, so let's go through this one more time. You must be thinking 'are you crazy? You expect this to happen?' You just talked about database lock. And in three days, how are you going to achieve this? To achieve the database lock, you need to have control over your study. You need to take a step back and understand the big picture and how the data is going to flow.
The four Cs - connect, collect, conform and consume
He said it could be done by a simple four Cs concept - connect, collect, conform, and consume. Connect and collect the data, conform it to any standard and consume it in a user-friendly way.
“So, in the Connect piece, this is when we connect to disparate source systems. We built a library of over 120 connected data sources. You may have central labs, eCOA devices, or any data source that you're using. You can select the connectors from our library, configure them to your study and then you are connected and can start collecting data. As data is ingested in the system, it is validated, transformed to conform to business rules and standards, aggregated and can be consumed by end users. This means that from the beginning, you can see all the data together and can evaluate the quality of the data.”
“I'm seeing all my data together. I can make proactive decisions. And that's where we make the difference. Yes, with Pfizer we did the connect and collect use case. And our platform does the four Cs, but we don't force it and everybody you can select which one of the Cs that they want to use to fix the problem they're trying to solve. CONFORM, he says, has the flexibility and the ability to be configured to address specific problems its clients are trying to address.
Two clicks or less
“We conducted many usability sessions with end users, focused on user experience. Our goal is to take any action and perform it in two clicks or less. That's what I put my team through and now 90% of any function in the consume interface is achieved by two clicks or less.”
“Looking at the big picture, I'm pushing my team to do 10 times better, not 10% better. That's where our attitude should be when we leave this conference. Now you can look at the different anomalies. You can look at the big picture. You can see the patient profile that has three years’ worth of data in a single view. You can easily see the different information all lining up, and when there are issues, you immediately spot them. They're all intertwined and connected, focusing on the stakeholder’s user experience.”