In this interview, conducted at the MIT Chief Data Officer and Information Quality Summit (MIT CDOIQ), ERT’s Chief Data Officer, Prakriteswar Santikary, PhD, discusses the data challenges facing the pharmaceutical industry today, including the need to integrate and harmonize clinical trial data from various sources in order to demonstrate safety and efficacy. He also reviews how ERT addresses these challenges through a modern, cloud-based data platform that ingests any type of data from any source, and delivers real-time analytics on trial risks so you can run complex clinical trials with confidence.
Q: What does ERT do?
A: ERT is a global data and technology company that minimizes risks and uncertainties in clinical trials for our customers ─ the world’s top pharmaceutical, biotech and medical device companies ─ who trust us to deliver the data they need to bring life-enhancing, and life-saving drugs to the patients who need them.
We help our customers demonstrate drug safety and efficacy, two critical components required by the FDA and other regulatory authorities. Not only do we provide data and technology expertise, we also provide scientific, regulatory and therapeutic expertise. Drug developers around the world know they can trust us based on the collective wisdom we’ve gained over the past 50 years – and the fact that our solutions have been used in the development of more than 50% of all FDA-approved drugs year after year.
Our solutions include cardiac safety, imaging, respiratory, and electronic clinical outcome assessment (eCOA) services as well as a suite of data analytics solutions that provide real-time trial information so that our customers can proactively identify and mitigate risks to keep their trials on track and on budget.
Q: What challenges do researchers face when collecting this important clinical trial data during drug development?
A: New drug development is very complex. It takes ten to fifteen years and costs about $2.5 to $3 billion to develop and commercialize a drug.
Clinical trial complexity has increased exponentially in recent years, creating significant data aggregation, management and reporting challenges. In addition to as many as 12 different data capture systems being used in any given study, the average number of sites and endpoints per trial has increased by 58% and 70%+, respectively. And since trial sponsors typically outsource all of this data collection to different vendors, they also have to coordinate with numerous providers and get them to collaborate with each other.
This is why data plays such a big role in clinical research ─ because now the data are everywhere, across different systems, and those systems don’t talk to each other. So how can you see what’s going on in your trial in order to make effective decisions when you don’t know where your data are? Having access to this important data in real-time is critical to keeping trials on track and on budget. This is where ERT’s data platform comes in.
Q: What data imperatives does ERT build into its platform to help customers overcome these challenges?
A: Trial sponsors are drowning in different types of data from many different sources: EDC data, lab values, data from wearables, eCOA, imaging data, etc. ─ all of which could be structured, unstructured or binary ─ and they normally don’t fit in one data store. So ERT has created a unique platform that gathers data in real time, in a data lake. And we implemented that platform on Amazon Web Services (AWS), a cloud-based, scalable data infrastructure, which gives us the ability to ingest as well as integrate data of any type or volume and coming to us at any velocity.
Q: What ERT products and services does this platform support?
A: Our core data platform supports all ERT services. So people can log on to our portal to get the info they need at any time. But we’ve also listened to our customers to design reporting and analytics solutions that take things to the next level. One of these is our Business Intelligence Suite, which centralizes clinical trial data capture from multiple disparate sources – whether via ERT’s safety and efficacy endpoint solutions or other clinical and operational data feeds ─ and gives sponsors/CROs powerful insights on the progress of their studies through configurable and customizable reports.
Another product is our Trial Oversight solution, a performance and risk management application that presents holistic, real-time clinical and operational data based on performance metrics, key risk indicators, and study milestones to give our customers greater predictability, protection and control of their studies. This allows them to proactively identify risks before they become costly problems.
Q: How does data governance come into play with the platform?
A: As you might expect, data governance is key because it indicates who owns which data and ensures its quality over time. We use a combination of tools, technologies, and processes to do this. And, as custodians of the data, we have a fiduciary responsibility to make sure that the data are ingested, gathered and integrated properly and then made available for real-time decision making. This enables our customers to make the right decisions based on the right information.
ERT’s clinical trial data platform and the solutions it supports enable us to deliver the highest quality data and really help our customers. That’s the end goal: To deliver high quality data they can trust.
Click here to learn more about how ERT’s Trial Oversight solution helps sponsors and CROs keep clinical trials on track and on budget.
Prakriteswar Santikary, PhD is ERT’s Chief Data Officer.